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FDA Simultaneous Marketing ANPRM

Bracketed Comment Letter Report

COMMENT NUMBER - 2005N-0345-EC11670

2005N-0345-EC11670 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Farren, Wanda

2005N-0345-EC11670 - TEXT

Issue Areas/Comments

A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC drug product?

<1: 3.9.1>FDA has precedent for simultaneous prescription and OTC usage, whether at the same or at different doses. The nicotine patch and ibuprofen are two examples. The patch is restricted to buyers ages 18 and older. </1: 3.9.1>

A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a matter of law?

<2: 6.4.1>Nicotine replacement products available OTC are "restricted" to persons 18 and older. </2: 6.4.1><3: 7.5.2>As a practical matter, enforcement appears to be up to vendors. I don't see local drugstores listed in the paper as being in violation of underage sales, and given FDA's personnel shortages, "enforcement" that would single out emergency contraception would reflect bias in the agency's priorities.</3: 7.5.2> <4: 6.7>Either science dictates an age cutoff, or it doesn't. </4: 6.7><5: 6.3.5, 6.4.1>In the case of nicotine replacement products, the legal age for purchase of nicotine is 18, so conforming labeling only makes sense. If the rule of law is cited for limiting distribution of an OTC product, it should be consistent with relevant statutes. In the case of EC, relevant statutes might be age of consent laws. These laws vary significantly from state to state, with the average age of consent being 14, but as low as 11 or 12, and as high as age 18. Nonetheless, this should not stop availability to persons who have aged out of those covered by these laws, and age 18 would be an appropriate cutoff age nationwide. </5: 6.3.5, 6.4.1>

B. If it could, would it be able to do so as practical matter and, if so, how?

<6: 7.4.1>Leaving the product behind the pharmacy counter would ensure only certain persons get the product, but it would also pose a barrier.</6: 7.4.1> <7: 6.5.4>Condoms are available OTC; there is no age verification.</7: 6.5.4> <8: 7.5.3>Cigarettes are available only behind the counter, but this has not stopped underage purchase, or purchase by older persons on behalf of those under age. Beer (and wine) in some states is available "OTC"--and while there are requirements for age verification, it is inconsistently done.</8: 7.5.3> <9: 7.4.6, 7.5.3>For a product that could be sold single-dose (or "use"), and for which the adverse effects are exceedingly rare, it makes no sense to try to screen every possible purchaser. As a practical matter, a purchaser under a state's legal age of consent should be reported to child protective authorities. I seriously doubt that retailers are prepared to do this. </9: 7.4.6, 7.5.3>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<10: 8.1>There would be no obvious reason why this would not be the case.</10: 8.1> <11: 8.4.1>The burden on the manufacturer would be less. There would be no particular reason a pharmacist could not dispense the individual product (dose of pills, whatever it is) via usual packaging for that pharmacy, however. </11: 8.4.1>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<12: 8.4.1>It would be inappropriate to charge any additional fee for either package; the price should be the same. </12: 8.4.1><13: 9.2.2>I can't imagine why it would be inappropriate to have simultaneous distribution channels, under any circumstances. This would be regulation run amok. </13: 9.2.2>

COMMENT NUMBER - 2005N-0345-EC117

2005N-0345-EC117 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Dorn, Kellie

2005N-0345-EC117 - TEXT

Issue Areas/Comments

<1: 1.2.3, 6.3.5, 7.5.3>I agree with the FDA's initial long-standing decision that a drug should not be used simultaneously both by prescription and used over-the- counter. It would be too dificult to enforce this decision to make Plan B OTC only to individuals 16 or older. Many teenagers don't have a driver's license until 17 or 18 years of age, so proof of age in itself is a problem. Also, even if the individual purchasing the contraception is 16 or older, what is to prevent these individuals from diverting Plan B to teens who are under 16 years of age? What is the magic age of 16 that makes this medication suddenly safe? I don't see a huge difference in judgement between a 15 year-old and a 16 year-old or 17 year-old for that matter. Finally, I feel that by making this emergency contraception available over-the-counter to anyone, it will replace a visit to a doctor, which provides a valuable service. In a single visit, a doctor can screen for STD's, pregnancy, HIV, and give a pap-smear. A patient could conceivably purchase a Plan B pack every time that this person has sexual intercourse and never see a doctor in her entire lifetime. This will raise the number of undetected STD's, increase the rates of undetected ovarian, endometrial, breast, and uterine cancers, increase the number of undetected HIV cases, and prevent patients from using conventional monthly contraceptive methods which require thought before engaging in sex and which require a yearly physical exam. I strongly urge you to consider the points I have made and retain Plan B as available by prescription only.</1: 1.2.3, 6.3.5, 7.5.3>

A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously market in both a prescription drug product and an OTC drug product?

<2: 3.8.4>I agree that if a medication is unsafe for some, it should remain as prescription only.</2: 3.8.4>

<3: 7.5.4>I don't feel that this law is enforceable, as not every teenager has state-issued identification, and significant diversion would occur to teenagers under 16 years-of-age.</3: 7.5.4>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<4: 8.2, 8.5.1>No these products could not be sold in the same package, as the law requires OTC products to comply to specific labeling requirements which are explicitly different than prescription labeling requirements. The labeling requirements for an OTC product are designed to educate the patient on safe use of the product, and the prescription packaging is designed to assist the health professional in education of the product.</4: 8.2, 8.5.1>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<5: 9.1.2>It would never be appropriate. </5: 9.1.2>

COMMENT NUMBER - 2005N-0345-EC12

2005N-0345-EC12 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Reynolds, Charles

2005N-0345-EC12 - TEXT

Issue Areas/Comments

<1: 3.8.1>Yes, this is an important decision for the future of health care in the US.</1: 3.8.1>

Yes, this is an important decision for the future of health care in the US.

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<2: 3.8.1, 4.5>The issue is not one of confusion. The question becomes one of establishing defined criteria for which a drug may be used and marketed both OTC and Rx.</2: 3.8.1, 4.5>

<3: 6.7>Unknown if the FDA has the ability to regulate this under its jurisdiction.</3: 6.7>

B. If it could, would it be able to do so as practical matter and, if so, how?

<4: 7.4.1>Yes. By creating a class of drugs that can be directly sold only by a licensed pharmacist. This makes a specific person responsible for effectively implementing what the FDA wants. It also protects the health and safety of US citizens by making them interact with a health care professional who can assess the request for appropriateness as well as potential problems.</4: 7.4.1>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<5: 8.1>Assuming there is no specific legal prevention, this would be acceptable.</5: 8.1>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<6: 8.5.3, 9.1.1>Can't think of any problems, unless regulatory action would require special record keeping to separate OTC use from Rx use... then separate packaging (and thus NDC code) would be important.</6: 8.5.3, 9.1.1>

GENERAL

<7: 1.1>This question, prompted by 'Plan B' product will become more prominent as time goes on unless the US deals with its health care crisis. </7: 1.1>

COMMENT NUMBER - 2005N-0345-EC121

2005N-0345-EC121 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Slee, April

2005N-0345-EC121 - TEXT

Issue Areas/Comments

<1: 3.2, 3.8.8>No. There are two reasons to have a drug available by prescription. One is so insurance covers it, like blood glucose test strips. The other is that a reasonable person can't be expected to take it safely and correctly without the direction of a doctor. On this second part, either a drug is safe enough or it isn't. Besides, anyone who is 15 is smart enough to get a 16 year old friend to buy it for them.</1: 3.2, 3.8.8>

No. Same reason. By the way, there's a typo here.

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<2: 4.2>No, I think the interpretation is reasonable and correct.</2: 4.2>

<3: 6.2, 6.3.4>No way. As a teenager, you need an 18 year old friend to by you smokes, a 21 year old friend to by you booze, and now you'd just need a 16 year old friend to buy you emergency contraception.</3: 6.2, 6.3.4>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<4: 8.2, 8.6.2>No. Obviously you are worried that the population needing the prescription can't be trusted to take it without the prescription, so you need warnings that address these concerns.</4: 8.2, 8.6.2>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<5: 9.1.1>If the risks are different, you need different warnings. </5: 9.1.1>

COMMENT NUMBER - 2005N-0345-EC12379

2005N-0345-EC12379 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Mershon, Claire-Helene

2005N-0345-EC12379 - TEXT

Issue Areas/Comments

<1: 1.2.1, 3.1, 3.8.5>Yes. Plan B should be available OTC, and while I disagree that it should be split between OTC and prescription, I understand the concerns of the FDA in taking the action for women under 16. However, this should not keep the FDA from keeping it off of the shelves completely. If an active ingredient is judged to be safe for use OTC by women, it should be sold that way. If it is necessary to make the drug prescription for one population in order for that to happen, then the FDA should review its rules and allow the drug to be available in both forms.</1: 1.2.1, 3.1, 3.8.5>

<2: 6.6.3>Yes. If the age of a person buying cigarettes or alcohol is subject to legal enforcement, why would this limitation not be enforceable?</2: 6.6.3>

B. If it could, would it be able to do so as practical matter and, if so, how?

<3: 7.4.1>One possible way to enforce this, if the FDA is worried about the populations purchasing the drug, is to keep it behind the pharmacy counter. The only stipulation would be that there must be one pharmacist available at all times who could not refuse to sell the drug to a customer because of its intended use. If the pharmacy were to control this sale or distribution, they could check identification in an area that is somewhat more private than the cash register, and they would also be available to answer any questions a woman might have about how to use the product.</3: 7.4.1>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<4: 8.1, 8.4.1>Yes. This would remove the burden on the part of the manufacturer to create different packaging. In addition, the current packaging is extremely straightforward, and they have made it easy to understand. If the current packaging works, as was ruled by the advisory committee, why complicate it further?</4: 8.1, 8.4.1>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<5: 9.2.1>I don't know what circumstances would make it inappropriate, but I don't believe that this is one of them.</5: 9.2.1>

COMMENT NUMBER - 2005N-0345-EC126

2005N-0345-EC126 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Dougherty, Anne

2005N-0345-EC126 - TEXT

Issue Areas/Comments

<1: 3.1>Yes</1: 3.1>

Yes

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<2: 4.1>Most consumers do not understand section 503(b)</2: 4.1>

C. If so, would a rulemaking on this issue help dispet that confusion?

<3: 5.3.2>It might, yes. Consumers look only at the availability and price of health care items. In an era where health care is available to far fewer people at an affordable price it is vital that the patient feel he or she is involved in healthcare decisions.</3: 5.3.2>

<4: 6.6.3>Limiting the sale of the "Plan-B" drug over the counter is no different under the law than limiting the sale of tobacco to people over 18 or alcohol to people over 21.</4: 6.6.3>

B. If it could, would it be able to do so as practical matter and, if so, how?

<5: 6.6.3>Yes, I believe so. Requiring proof of age is in no way an infringement on the right to privacy. As long as it is only proof of age, in the form of a government issued identification, that is required, enforcement of such a regulation could be turned over to the same agency that enforces alcohol and tobacco regulations.</5: 6.6.3>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<6: 8.4.1>Unless there is a dosage difference, I believe that marketing exactly the same product in different packaging would cause undue stress to the consumer of the product. Anyone considering using the "Plan-B" contraceptive is already facing a tough decision; packaging and marketing should not add to any already existing impediments.</6: 8.4.1>

COMMENT NUMBER - 2005N-0345-EC13

2005N-0345-EC13 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Clague, Alexander

2005N-0345-EC13 - TEXT

Issue Areas/Comments

B. If it could, would it be able to do so as practical matter and, if so, how?

<1: 7.4.4>There are two obvious circumstances where products are limited for purchase on the basis of age: alcohol and tobacco. If a pharmaceutical product were to be sold based on age-related criteria, similar protocols from what are in existence today should suffice to ensure compliance with the laws. In addition, since Plan B is not habit forming, the way alcohol & tobacco products are, some of the restrictions on advertising which exist for tobacco would not be necessary in the case of Plan B.</1: 7.4.4>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<2: 3.9.1, 8.3.1, 8.7>This is an odd question, since omeprazole (brand name Prilosec) is currently being sold both as a prescription and as an OTC product. The distinction that the OTC product is a different salt than the prescription product has no biologic significance. Accordingly, the same package may be used so long as the "OTC" product contains whatever required language the "prescription" product would require so that there would not be any problems where a pharmacy were "out of stock" of the prescription product while still having an inventory of the OTC product.</2: 3.9.1, 8.3.1, 8.7>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<3: 9.3>only if the "package insert" information is not available for the "prescription" sale.
</3: 9.3>
GENERAL

GENERAL

<4: 1.2.2>Plan B is safe and should be sold over the counter. If young girls are required to obtain a prescription for it, the packaging should be created to ensure flexibility regarding the type of sale so that there are no inventory "shortages" for either the OTC or prescription sale. </4: 1.2.2>

COMMENT NUMBER - 2005N-0345-EC13026

2005N-0345-EC13026 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Thomas, Tiffany

2005N-0345-EC13026 - TEXT

Tiffany N. Thomas
Paper Assignment
Political Science 3700
October 31, 2005

ANPRM published in the Federal Register vol 70 no. 169, pages 52050-52051;
Docket No. 2005N-0345 and/or RIN number 0910-AF72,

<1: 7.5.3>In response to the Advance Notice is Proposed Rulemaking, about what types of drugs should be sold simultaneously both by prescription and over the counter, and it has major implications for the so-called "Plan B" emergency contraception. I think that all drugs should only be available through prescription or over the counter and not both. In my opinion it is absurd to have both. Like many others I think there is no point in going to the doctor and when one could just go to their local CVS or Eckerd and buy the same thing they are getting with a prescription over the counter.</1: 7.5.3> <2: 3.11>Another issue I have with having both is will the dosage be the same. If you are going have both, then the amount of the active ingredient should be less in the over the counter drugs. </2: 3.11>

<3: 3.8.4>According to Lester M. Crawford at one time the Federal Drug and Administration "used to prohibit products from being sold both over the counter and prescription at the same. The idea was if an active ingredient was safe and effective with out practitioner's supervision it had to be over the counter." I think that is a major reason that drugs should only sold either over the counter or by prescription no simultaneously. Prescriptions have physician advisory; your doctor can control the amount of the drug you receive and how often you receive it. Whereas, with the over the counter you are only consulting your pharmacist, who does not know you medical history and can not adequately make sure that it is safe for someone's particular body type. This could be dangerous and harmful to your health. Also, with prescriptions somebody can keep track of how much you receive and you can only get the amount that your doctor has prescribed. When a drug is sold over there is no way for you to keep track of who gets what and how much. With drugs such as the "Plan B" drug there would need to be some sort of data base to keep track of who purchases, so that people could not abuse the system, and go from store to store every other day and be like I need this pill. There should a limit on how much you can receive with in a certain time frame.</3: 3.8.4>

<4: 3.11>Another big factor in determining whether drugs should be sold in both prescription and over the counter is the amount of the active ingredient that is in the drug. If the drugs are going to be sold simultaneously then the dosage should be different in the over the counter drug than it is the prescription drug. That way people could not abuse the drug. In regards to the "Plan B" drug lowering the dosage and selling it in a single package would be essential in making sure that women do not act irresponsibly and try to take multiple dosages of the drug. </4: 3.11>

<5: 7.5.3>One of the questions regarding the "Plan B," drug is "should age by a criterion on which we decide whether a drug is sold as a prescription product, or an over-the-counter product…how as a practical matter, would such a limitation be enforced." This is a big question and is one that is difficult to answer; we can not fully enforce keeping kids from smoking and drinking so how can someone enforce keeping underage girls from gaining access to this drug. I think that if the "Plan B" pill is sold by prescription only then it would make it harder for underage girls to get. With a prescription the girls will have their doctor's supervision and it will adequately prescribe to their particular body type. When it is sold over the counter to older girls the younger teens will just ask their friends who are of age to go and buy it for them the same way in which they do other things they are to young to buy for themselves. Another major reason that it drug should be sold by prescription only is there would be no way to really enforce the age limit, girls could get fake identification and then what would be the point, with a prescription then the pharmacist knows who the person is and what their real ages. </5: 7.5.3>

<6: 7.6>Furthermore, how would this affect insurance? If the drug is sold over the counter how would this affect your insurance; would your insurance provider tell you to buy the over the counter version instead of the prescription version of the drug? If you sold the drug both over the counter and by prescription, then I think the over the counter version should be more costly than the prescription this would also prevent people from misusing the drug. If the over the counter drug cost more than the prescription then people would be more careful and would take the time out to go to the doctor and get a prescription instead of just going the pharmacist.</6: 7.6>

<7: 3.11>There is no reason for a drug to be sold over the counter and by prescription simultaneously, it is absolutely pointless. It should be sold either by prescription or over the counter not both, there is no way that you could regulate how much a person receives and how often if it is sold both ways. When a drug such as the "Plan B" pill is sold both ways there would be no physician advisory for the people who received the drug over the counter there would be no way to tell what the effects were on their bodies this could possibly be dangerous to our society. Many may argue that this is a good idea especially in special circumstances like rape, because then the drug will be very assessable in a limited amount of time. However, I do not think that it is even a good idea in special circumstances such as rape, because once again this would cause people to not to see their physicians who can adequately tell what is right for a particular body type. When something is sold over the counter it can be misused easier than prescription drugs and there is no way to limit and record who takes it and how much, therefore all drugs should be sold either by prescription or over the counter.</7: 3.11> <8: 1.2.3>The "Plan B" is one of those drugs that should be sold only by prescription and not over the counter. </8: 1.2.3>

COMMENT NUMBER - 2005N-0345-EC13197

2005N-0345-EC13197 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Chihane, Ziad

2005N-0345-EC13197 - TEXT

GENERAL

See Attachment

2005N-0345-EC13197-Attach-30.DOC

ATTACHMENT:

Ziad Chihane
3027 Henderson Mill Rd.
Atlanta, Ga 30341

Drug Approvals: Circumstances Under Which an Active Ingredient May Be Simultaneously Marketed in Both a Prescription Drug Product and an Over-the-Counter Drug Product.

Agency: Food and Drug Administration, HHS
Action: Advanced notice of proposed rulemaking.
Docket No. 2005N-0345
RIN: 0910-AF72

<1: 3.1, 4.1, 5.1>The rulemaking in question is of utmost importance in regards to health and safety of citizen of the United States. The FDA should absolutely initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously marketed in both a prescription drug product and an OTC drug product. The act in itself is unclear and with the high degree of importance that medicine serves to citizens it is imperative that there be rulemaking in regards to this issue. The confusion that occurs with the FDA's interpretation of section 503(b) is that they have set limits in the amount of dosage that something can have depending if it is OTC or a prescription drug. But this is not very clear this is why I believe that FDA should go into a more effective rulemaking process to better regulate this issue. The way that the rule is currently setup I believe leaves a lot of room for speculation, which is not something that needs to be done with prescription or OTC drugs. If we don't put a more effective rule on the section 503(b) it could eventually get out of control. So yes I do believe that rulemaking on this issue would dispel the confusion that is along with this section 503(b).</1: 3.1, 4.1, 5.1>

<2: 6.1, 7.3.1.1>The FDA like other Federal administrations has many processes to ensure that the rules that they make and administer are followed. So if the FDA does continue with rulemaking in respects to the section 503(b) they would certainly be able to enforce the rules that have been made. As long as the FDA makes the law so that it is constitutional then there should not be a enforcement problem in respects to the rules made. I think that this would be somewhat of an easy thing to control because the enforcement would be on a broad level. The FDA would have to regulate the pharmaceutical companies by telling them how the product will be distributed and then the pharmacies that distribute the drugs will only do so if a licensed practitioner prescribes it. Although this would be more difficult if the rulemaking affected drugs that where previously OTC and then they become prescription drugs. This I believe would cause a problem in regards to enforcement because people will be upset over the new rule but in the end the new rule will be more effective. The rulemaking enforcement would be practical from a forward perspective clearly it would take a while for companies and pharmacies to change in respects to the new rules but it would be done and it will be affective.</2: 6.1, 7.3.1.1>

<3: 8.2, 8.9>With the new rulemaking if the prescription and OTC product are going to be allowed to be sold they should not be sold in the same package. Depending on what you need the medicine for if they are packaged together this may lead to abuse of the product and that would clearly not be the purpose of the rulemaking. I don't agree with the being sold in the same package but if it was to do so I believe that it would be inappropriate if the packaging didn't clearly state the differences between the two different levels of drugs that would be contained inside the packaging. I also think that it would be inappropriate to package the two drugs if they had side effects that may be different depending on the dosage cause I feel that this would also lead to abuse.</3: 8.2, 8.9>

<4: 4.1, 8.2, 8.6.2>Overall I don't believe that drugs should be packaged together or that there should be higher doses that could be taken without a practitioner to determine the level of drug that is needed. Drugs are a serious problem in the United States and if the FDA loosens up the restrictions on higher dosage drugs then this will lead to a more abusive situation in regards to prescription and OTC drugs. Also I do believe that if this was done it will take away some of the professionalism from the health professionals and people will self medicate without the proper knowledge and this could lead to serious side affects. Clearly there needs to be a more clear interpretation of the section 503(b) so that it is more effective clear and most importantly that it will have safe rules for people. If this can be done the FDA has done their job on this matter.</4: 4.1, 8.2, 8.6.2>

COMMENT NUMBER - 2005N-0345-EC132

2005N-0345-EC132 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Peters, Jeanette

2005N-0345-EC132 - TEXT

Issue Areas/Comments

<1: 3.8.3, 3.8.5>It is logical to update codes to include provisions for the simultaneous marketing and selling prescription and OTC drugs. This is especially clear in a case where age is the deciding factor: adult users should not have road blocks put in their way when they seek to buy safe, legal medication. Consider: we do not need a prescription or other form of authorization to buy alcohol, though its selling is age-based. In the case of medication, the issue of accessibility can be much more critical: patients rarely have a chance to get a prescription over the weekend, for example, and some medications are heavily time-sensitive.</1: 3.8.3, 3.8.5>

It is logical to update codes to include provisions for the simultaneous marketing and selling prescription and OTC drugs. This is especially clear in a case where age is the deciding factor: adult users should not have road blocks put in their way when they seek to buy safe, legal medication. Consider: we do not need a prescription or other form of authorization to buy alcohol, though its selling is age-based. In the case of medication, the issue of accessibility can be much more critical: patients rarely have a chance to get a prescription over the weekend, for example, and some medications are heavily time-sensitive.

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<2: 4.1, 4.3.4>Significant confusion exists, especially in light on concerns that section 503(b)'s criteria may unfairly and negatively impact accessibility to legal and scientifically-validated medications.</2: 4.1, 4.3.4>

C. If so, would a rulemaking on this issue help dispet that confusion?

<3: 3.7.1, 5.1, 5.3.1>Rulemaking, in accordance with ADA section 553, is needed as a matter of public health via increasing accessibility to safe, legal medications and removing the unfair burdens currently upon consumers.</3: 3.7.1, 5.1, 5.3.1>

<4: 6.6.3>Analogously to the ATF and tobacco/alcohol regulations, a limitation on availability to a subpopulation could be enforced.</4: 6.6.3>

B. If it could, would it be able to do so as practical matter and, if so, how?

<5: 6.6.3, 7.4.4, 7.4.6>Insomuch as any other law may be practically enforced, the FDA would be able to enforce regulation concerning availability to a subpopulation. As with other agencies' laws, a large pool of enforcement possibilities exist. On the front end, consumers regulations can require that customers prove their age, as with alcohol and tobacco purchases. On the back end, penalties including but not limited to fines and eventual closure of offenders' operations have been used to enforce agency laws.</5: 6.6.3, 7.4.4, 7.4.6>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<6: 8.6.2, 8.6.4>Assuming that it is legal to market the same active ingredient in both a prescription and OTC product, product labeling remains an issue very distinct from the allowing for availability of a product to a subpopulation. The FDA should seek a removal of barriers on consumers that impede their access to safe, legal medications, especially when these medication are time-sensitive in nature. While diverse labeling costs the manufacturer somewhat more, labeling OTC products differently from prescription products when both are simultaneously available will facilitate in avoiding customer and seller confusion, and allow for easier enforcement of regulations concerning sale to a subpopulation.</6: 8.6.2, 8.6.4>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<7: 8.5>As discussed previously, ease of enforcement and concerns about vendor and/or customer confusion would warrant selling the products under different labeling.</7: 8.5>

COMMENT NUMBER - 2005N-0345-EC135

2005N-0345-EC135 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Severance, Peter

2005N-0345-EC135 - TEXT

Issue Areas/Comments

<1: 3.2, 3.8.8>No. Why are you complicating this? The FDA is supposed to regulate drugs based on clinical evidence, not make social policy.</1: 3.2, 3.8.8>

Is this a mistake? You have two Issue Areas marked 1 A -- with slightly different wording...both of which seem to be grammatically incorrect and/or contain spelling errors?

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<2: 4.1, 4.3.4>Yes. Unfortunately, it is the FDA which has created the confusion. If there is clinical evidence that a significant portion of the target population may be adversely affected by dispensation under non-prescription protocols, then the drug should only be dispensed as a prescription drug.</2: 4.1, 4.3.4>

C. If so, would a rulemaking on this issue help dispet that confusion?

<3: 5.2>No</3: 5.2>

<4: 6.5.4>Irrelevant. The FDA would be creating an overly-complicated system of enforcement.</4: 6.5.4>

B. If it could, would it be able to do so as practical matter and, if so, how?

<5: 7.5.4>Irrelevant. The FDA would be creating an overly-complicated system of enforcement. </5: 7.5.4>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

Irrelevant. The FDA would be creating an overly-complicated system of enforcement.

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

Irrelevant. The FDA would be creating an overly-complicated system of enforcement.

GENERAL

<6: 3.8.4, 3.8.7>You should not be growing a government bureaucracy in order to achieve someone's idea of social policy. If a drug carries clinically proven risks to the affected population, it should be dispensed only by prescription. Period. End of story. Don't play games with drug regulation. The agency's credibility is already on shakey ground.</6: 3.8.4, 3.8.7>

COMMENT NUMBER - 2005N-0345-EC13643

2005N-0345-EC13643 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Kwak, Eugene

2005N-0345-EC13643 - TEXT

GENERAL

see attachment

2005N-0345-EC13643-Attach-33.TXT

ATTACHMENT:

Eugene Kwak
3078 Devauden CT
Duluth, GA 30096

Comment on Notice of Proposed Rulemaking
FDA
Docket #: 2005N - 0345

The benefits that may arise from selling some prescription only medicines over-the-counter as well to the end-user consumer are greater than any possible affliction it may cause upon society. For instance it allows for better accessibility, raised competition amongst businesses, and promotes the idea of free choice and personal accountability. There are, however, many possible drawbacks if this were to happen, but the benefit makes it a greater need.

<1: 3.9.1>One may argue that if pharmaceuticals were placed as an over-the-counter drug, it would allow abusers to gain easier access to a substance. Well, naturally the FDA would be drawing a line as to what is and what isn't going to be sold in both market areas. Drugs such as hydrocodone, a powerful painkiller and opiate, would not move from its prescription-only status, naturally due to its potency and highly abusive properties. There are already drugs being in both areas, even today. Acetaminophen, Tylenol's active ingredient, is sold in its original non-prescription form and in prescription strength. What is the difference between the two and why is Tylenol given such treatment? Acetaminophen, unlike hydrocodone, is not highly addictive and doesn't have a likelihood of being abused. Also, the non-prescription form is roughly one-third the amount of acetaminophen per pill. So, if we were to avoid the problem of abuse, then a line should be drawn as to what can and what cannot be moved to the shelves.</1: 3.9.1>

<2: 3.8.3>Accessibility would be such an advantage to almost every person there is. Not everyone can go to a doctor at 12am midnight to get a prescription for some powerful nasal decongestant when that person needs it. If the prescription strength nasal decongestant was moved down to the over-the-counter level, it would be available to the person at all times. Also, the less fortunate low-income families would be allowed greater access to medicines as well. Doctor fees are expensive and many of the country's poor are unable to pay these fees and receive proper treatment or medication for their problems, simply due to being unable to pay the costs. If some medicines moved over-the-counter, even these people would benefit for having access to the drugs without the hefty doctor fee.

Moving medication to the shelves can also heighten the level of business competition. It would increase the market size that these companies can sell to. This would make more companies strive harder to reach this market at even further horizons. An initial effect and end effect would be the lowering of costs for medications for the end-user consumer as well. Also, if companies are doing better here, that shows in the status of the country's economy as a whole, so I cannot see where we are being hurt on this matter by going through with this process.</2: 3.8.3>

<3: 3.8.3>America's governing principle is that of liberty, which is also being able to choose and take accountability and responsibility in your actions and the choices you decide to make. So how would moving medicines over-the-counter promote this ideology? Well, if the people aren't able to choose what they can and cannot do for themselves, then isn't that a lack of liberty? Currently, the liability and accountability, for the use and sales of prescription medicines is placed largely on the doctors who prescribe them. If they were to prescribe a patient the wrong medicine, then that doctor would be facing some form of punitive measure. If people were allowed to choose for themselves what is best for them, they would simply be taking liability and responsibility for their own actions. This is the first fundamental step to liberty. People should be able to choose whether or not to take some medicines if they felt the need to be treated.</3: 3.8.3>

<4: 3.8.3>What should the FDA do? I believe the FDA should follow through with this rule, but make sure there is some form the threshold in place to insure that highly abusive substances, such as hydrocodone, be kept out of the open market and behind the counter as it is today. However, going through with the process would enhance accessibility of the medicines to anyone in need, business competition would be heightened, the idea of personal liberty and accountability would be nothing but promoted to a greater degree. These are but a few of the reasons as to why the FDA should follow through with this rule.</4: 3.8.3>

COMMENT NUMBER - 2005N-0345-EC13845

2005N-0345-EC13845 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Rahl, Michael

2005N-0345-EC13845 - TEXT

Issue Areas/Comments

There is sufficient reason for the FDA to initiate a rulemaking to codify its interpretation of Section 503(b) as to when an active ingredient can be simultaneously marketed in both a prescription drug product and an OTC drug product because the lack of legislation has created interpretations that have had some success but whose scope is not broad enough to address concerns that arise outside of their margins that focus primarily on the safety to the consumer. In the absence of such codification we find misspent FDA resources, delay on the marketing of certain drugs, a consequent profit loss by pharmacies and pharmaceutical companies, and specific needs of members of our society have been put on hold while the FDA balks in this decision making process. In codifying the aforementioned interpretation of section 503(b), the FDA could maximize its procedural efficiency and increase its service level output to the nation which would generate broader levels of satisfaction to society?s needs.

2005N-0345-EC13845-Attach-34.TXT
2005N-0345-EC13845-Attach-35.DOC

ATTACHMENT:

Michael Rahl
7931 Roswell Road Apt. F
Atlanta, GA 30350
Food and Drug Administration
Docket: 2005N-0345

<1: 3.1, 3.8.1>There is sufficient reason for the FDA to initiate a rulemaking to codify its interpretation of Section 503(b) as to when an active ingredient can be simultaneously marketed in both a prescription drug product and an OTC drug product because the lack of legislation has created interpretations that have had some success but whose scope is not broad enough to address concerns that arise outside of their margins that focus primarily on the safety to the consumer. In the absence of such codification we find misspent FDA resources, delay on the marketing of certain drugs, a consequent profit loss by pharmacies and pharmaceutical companies, and specific needs of members of our society have been put on hold while the FDA balks in this decision making process. In codifying the aforementioned interpretation of section 503(b), the FDA could maximize its procedural efficiency and increase its service level output to the nation which would generate broader levels of satisfaction to society's needs.</1: 3.1, 3.8.1>

<2: 3.9.1>The FDA has deemed it appropriate to market the active ingredient in both formats under four conditions: indication, strength, form of dosage, and the manner of product administration. The impetus for these four criteria and the permission to market dual forms of an active ingredient that has varying formula constitutions have been based on the relative safety of the individual that is using the products. A drug such as Meclizine, which in its prescription form is used to treat vertigo and nausea in its OTC form, was tested and deemed to be safe for public consumption in either of the two forms. If one were to examine several of the other drugs that have been evaluated in a similar fashion by the FDA, they would witness the development of a theme which binds this accepted category together: these drugs are not ethically, morally, or normatively questionable to society. </2: 3.9.1>

<3: 1.2>Why should social values be mentioned at all? There are new classes of drugs that are emerging whose utilization challenges the moral consciousness of an influential and conservative sector of America. A case in point is the drug Levonorgestrel, or Plan B, that was created by Barr Laboratories. After The Center for Drug Evaluation and Research (CDER) completed its review of Barr's amended application, it scientifically concluded that the drug was safe to use as an OTC product for women who are 17 years of age and older. Still the FDA is unable to reach a decision on the acceptability of the application because it contends that it has never determined whether a drug may be simultaneously prescription and OTC based on the factor of age, it questions how the an age minimum could be enforced, and it has not dealt with the issue of versions of the same active ingredient being marketed in a single package. These newly emergent issues do pose as a legitimate policy oriented challenge to the FDA, but it cavaliers this as a façade because it is overwhelmed by the extraneous pressure exerted on it from morally conservative groups that have political and economic clout in the United States. </3: 1.2>

<4: 3.8.1>In codifying its interpretation of section 503(b), the FDA will need to include direct and coherent policy statements that diminish the incomprehensive rhetoric that it currently ascribes to its decision making in section 503(b). The agency should present a multifaceted application that is capable of addressing the contemporary drug product needs of subpopulations such as young adults, that advises pharmaceutical companies of their responsibilities to the FDA in receiving its approval for the less mainstream drug products, that prescribes to the pharmacies and doctors exact procedures as to how and to whom they will distribute these products, and the FDA should refine and make available to anyone concerned their own internal procedures and time frames under which occur the approval processes for such drugs. </4: 3.8.1>

<5: 7.4.4>In the previous section one of the numerous recommendations touched upon the issue of distribution of medication. This is an issue of key importance that might very well merit more consideration and analysis than the issue of codification. Several questions that will now be addressed have arisen around this precept that pertain to dispensing the products to subpopulations as prescriptions only, enforcing this restriction, and the practicality of doing so.

The FDA has to distinguish between the prospective populations that will be purchasing the drug products by delineating them as minors from adults. Let the tobacco sales legislation be a framework for which the sale of drug products will follow suit. If the individuals are at least eighteen years of age, they should be allowed to purchase the same active ingredient as a prescription or as an OTC drug free of age restriction guidelines. If the individuals are minors, they should not be prohibited to purchase the active ingredient in its OTC form. They must be restricted to the active ingredient on a prescription only basis whereby they will be required to first have the consent of their legal guardian and if they cannot obtain this, then they may purchase the drug independently provided that the licensed professional has made a valid attempt to notify their guardian to make them aware of the situation.</5: 7.4.4>

<6: 7.3.2, 7.5.3>The second condition has limitations but it is a proposal that functions on a basis that can negotiate, head on and realistically, the challenges that confront the FDA and those that are charged with prescribing and selling prescription drugs. An inevitable reality is that subpopulations will need reproductive and other nontraditional drugs. Another issue is that there might be circumstances where it is impossible to directly contact the legal guardian for consent or to inform them of what is transpiring. Finally, if an individual needs a drug product, and this will hold true especially in cases of emergency for the individual, there is no amount of legislation or enforcement that can prevent the individual from obtaining what they want. This would suggest that the FDA limit its attempts at enforcement and allocate its financial resources to education which proves to be more effective than policing. Reference the "War on Drugs" for a more accurate presentation of how the combatant attitude is ineffective as we still have the largest drug epidemic in the world. To reiterate, the second principle that applies to minors requires a minimal awareness contact by the licensed professional to the legal guardian and the drug must be on a prescribed basis. This idea is essential because in effect it says: "As a morally responsible society, we recognize that we have an obligation to regulate the privilege of the subpopulation purchasing these drug products, absolute control is not a possibility and is counterproductive to our agenda, and we will not endanger their wellbeing nor deny them of their civil liberties by some authoritarian stranglehold." </6: 7.3.2, 7.5.3>

<7: 3.8.1>If the FDA were to formulate policies based on the general principles mentioned here in the codification of its interpretations and in the principles of regulatory distribution, if it were to align itself to the needs of a more contemporary America, and if it could stand firm and make decisions in the face of its opposition, it would function as a far more effective federal agency. </7: 3.8.1>

COMMENT NUMBER - 2005N-0345-EC13851

2005N-0345-EC13851 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Nguyen, Marie

2005N-0345-EC13851 - TEXT

GENERAL

For the action of the advance notice or proposed rulemaking, a request to the public for comments on the issue confronting the FDA whether or not to initiate a rulemaking to codify it interpretation of section 503[b] of the Federal Food, Drug and Cosmetic Act, regarding when an active ingredient may be simultaneously marketed in both prescription drug product and an over-the-counter drug product. With that question, being proposed, other minor concerns arise from this proposal. <1: 3.1>Addressed in this comment are the reasons why I believe there should be an imitative in rulemaking and following are the comments on certain concerns. </1: 3.1>

<2: 3.8.1>The FDA should initiate a rulemaking to codify it interpretation of section 503[b] of the act regarding when an active ingredient can be simultaneously marketed in both a prescription drug product and an OTC drug product. With the dichotomous description of the prescription drug and OTC, there have been problems with the interpretation of section 503[b]. In initiating this rulemaking, the benefits would include a simple interpretation of the prescription drug and the OTC drug?s meaning, and a more absolute guideline for the FDA to use to regulate the drugs.</2: 3.8.1> <3: 4.1>There is significant confusion in regarding the FDA?s interpretation of section 503[b].</3: 4.1> <4: 4.3.3>The act does not define OTC drug. This has caused the confusion over what can be marketed and hence the debate over which drug can be available in both fields.</4: 4.3.3>

<5: 5.1, 5.3.2>A rulemaking would be the key to help dissolve the confusing language in section 503[b] of the act. With an adjustment and a revision to the language brought on by the rulemaking, this would allow an easier interpretation of the meaning of what constituents a prescription drug or an OTC drug. </5: 5.1, 5.3.2>

<6: 6.1>The FDA would be able to enforce the limitation as a matter of law to the sale of OTC product to a subpopulation.</6: 6.1> <7: 6.6.3>Anything can be enforced with the use of law. A clear example is the controversy concerning Plan B. There is a concern regarding the ability to regulate the purchase of Plan B if made OTC to the subpopulation, which would be women under the age of 16. The regulation still allows for Plan B to be available, but if you are of the subpopulation, the purchase would be through prescription rather than OTC. This enforcement would be similar to cigarette sales.</7: 6.6.3> <8: 7.1>The enforcement can be a practical matter.</8: 7.1> <9: 7.4.4>It would be as said above, similar to cigarette sales. There would be an enforcement such as age limits to a certain OTC drug. Purchases would be prohibited for OTC drug if that individual does not meet the limit. </9: 7.4.4><10: 7.4.5>Other enforcement would be setting heavy fines or penalties to deter purchasers to purchase OTC drugs if they do not meet those limitations. </10: 7.4.5>

<11: 8.3.4>If the prescription and OTC drug were able to be marketed in the same label, I believe that there is no harm and that it can be legally be sold with the same package. Furthermore, the package would have to display accurate information of the drug, such as the dosage or strength of the drug. </11: 8.3.4>

COMMENT NUMBER - 2005N-0345-EC141

2005N-0345-EC141 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Connors, Meaghan

2005N-0345-EC141 - TEXT

Issue Areas/Comments

<1: 3.1>Yes. Doing so would move this prolonged, highly politicized process.</1: 3.1>

Yes, as answered above.

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<2: 4.1>Confusion at best, disillusionment at worst.</2: 4.1>

C. If so, would a rulemaking on this issue help dispet that confusion?

<3: 5.1>Hopefully.</3: 5.1>

<4: 6.6.3>Absolutely, a prescription would not be necessary. No prescription is required for cigarettes or alcohol or lottery tickets, and those items are available only to specific populations.</4: 6.6.3>

B. If it could, would it be able to do so as practical matter and, if so, how?

<5: 1.2.1>Individuals over the age of 16 should be able to freely purchase this safe, important product. This product will undoubtedly prevent countless abortions and medical complications.</5: 1.2.1>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<6: 8.4.1>If they are in fact the same product with the same specifications, I don't see the relevance of this question.</6: 8.4.1>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<7: 9.3>This seems to be an unnecessary question; perhaps any implications by having the product sold in a single package should be further explicated by the FDA, as this is the FDA's area of expertise.</7: 9.3>

GENERAL

<8: 1.2.1>I am grateful to Dr. Woods for taking a stand. Commissioner Crawford's latest 'action' on Plan B, which is actually a lack of action, is most disconcerting and sullies the FDA's reputation, in my opinion.</8: 1.2.1>

COMMENT NUMBER - 2005N-0345-EC14261

2005N-0345-EC14261 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Owens, B

2005N-0345-EC14261 - TEXT

GENERAL

<1: 4.3.3>This submission is in response to FDA Advanced notice of proposed rulemaking of Docket number 2005N-0345. It is quite apparent that the issue that is in contention now has obviously been one of great controversy for quite some time now. Upon submission of the Federal Food, Drug, and Cosmetic Act, there was already confusion as to which drugs were acceptable for public use without the supervision of a licensed medical practitioner and which drugs were not. Section 503(b), which was enacted in 1951, was the attempt to remedy the aforementioned confusion. The apparent problem with section 503(b) is that it attempts to regulate any product which we now term as an OTC drug, but in doing so fails to give a clear definition of the term. In fact, the term OTC is missing from the section altogether. In solving the problem and answering the questions put forth for submission, the most obvious remedy comes in the form of precedent. The key question is whether or not an active ingredient can be simultaneously marketed as both prescription drug and OTC. Several drugs that have been released over the years have done so, but only when a meaningful difference exists between the two products, (i.e. ibuprofen given at 400+mg for arthritis but given at 400mg and below for aches and pains). </1: 4.3.3><2: 6.5.2>The FDA has yet to approve a drug for both OTC sale for one population and prescription in another population, but the biggest question is why? Obviously there are legal issues associated with such a drastic shift in the policy of public administration of drugs, and it should be apparent for one simple fact: time. It is apparent because of the length of time that this issue has been debated. Section 503(b) was introduced in 1951, and has remained the standard for the last 50+ years not because the policy was written so well and works so effectively, but because it is simply not possible to accomplish the aforementioned task of dual marketing to OTC and prescription population on the basis of age alone.</2: 6.5.2>

<3: 6.5.2>The most prominent advocate of this theory is the Plan B drug. The drug was proposed for marketing to both OTC and prescription patrons based on age restrictions. The makers of Plan B want to make the drug available for OTC sale to women age 16 and older, but simultaneously make it available to women under the age of 16 by prescription only. The problem with this is that there is not significant evidence in the research presented by the drug maker to show that women under the age of 16 can safely use the drug without professional supervision of a practitioner licensed by law to administer the drug. Also, it is furthermore obvious that this burden of proof is too great for the drug maker to handle, due not only to the fact that new studies of the drug have not been released since the initial submission of the new drug application on April 16, 2003, but also to the significant fact that a follow up proposal was made more than 30 times over the course of about a year.

The burden of proof is too great to be tackled at this time. Precedent has made it more than obvious that dual marketing of a drug on the basis of a difference that cannot be shown as being a meaningful bar of separation is not possible. It could not legally be done due to the fact that any active ingredient administered to one population by prescription and to another population OTC without meaning difference proven by research would be viewed as discrimination. Therefore sale of any drug to one individual over another without a proven valid basis is illegal. </3: 6.5.2>

<4: 8.1, 8.4.1>Furthermore, the question of whether or not the drug should be marketed in the same packaging OTC and by prescription is technically a waste of time. . If a prescription box of an active ingredient was given to a patient, then they acquired an OTC box of the same active ingredient, there would be no meaningful difference in the patient choosing to use one box over the other. Having two packages for the same item is not necessary.</4: 8.1, 8.4.1>

COMMENT NUMBER - 2005N-0345-EC14388

2005N-0345-EC14388 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Soriano, Lauren

2005N-0345-EC14388 - TEXT

GENERAL

"See Attachment"

2005N-0345-EC14388-Attach-37.TXT

ATTACHMENT:

Lauren Soriano
1257 Raleigh Way
Lawrenceville, GA 30043

In response to dual approval for prescription and over-the-counter pharmaceuticals, Docket No. 2005N-0345:

<1: 2.2>Since the Food and Drug Administration cannot decide whether or not to approve the selling of Plan B as both a prescription and over-the-counter drug, the action of taking an advanced notice of proposed rulemaking is a good idea. If any agency is having problems with deciding whether or not to initiate rulemaking, an ANPRM should be taken immediately. However, the Food and Drug Administration does have evidence and recommendation from the FDA staff regarding the approval of the drug, which makes the ANPRM seem pointless. But since the FDA commissioner, Lester M. Crawford, seems to take the politics behind the Plan B drug into account, an action should take place because neither the staff of the agency, such as Susan Wood, nor the public wants any more delay with rulemaking. Seeing that the Plan B, emergency contraceptive, is such a sensitive issue, the FDA should look and take every aspect into account due to the consequences one decision could have on a lot of people, especially women.</1: 2.2>

<2: 3.1, 3.8.3>The Food and Drug Administration should initiate rulemaking in order to see if an active ingredient can be simultaneously marketed in both a prescription and over-the-counter drug. However, there has to be stipulations on the over-the-counter drug because if the same active ingredient is in both the prescription product and the over-the-counter product, then what would be the purpose of a prescription drug. People would just flock to the OTC drug, since it is so accessible. </2: 3.1, 3.8.3> <3: 5.3.2>Also, Section 503(b), the active ingredient segment, should be more clear and cohesive so that there is no confusion regarding the interpretation of that section. The only way to ensure that section 503(b) would change is if rulemaking is put into affect. No drastic change in the section would be taken seriously without rulemaking approved by the FDA. </3: 5.3.2> <4: 3.9.1, 6.3.4>If the FDA did approve of the selling of Plan B as both a prescription and over the counter drug, they would have to make stipulations. Limiting the sale to a particular subpopulation should be one of the stipulations that the over-the-counter product should have. Just as other OTC products like flu medicine are sold, Plan B should be sold to women age eighteen years or older and remain as a prescription for others that are under the age of eighteen years old. Much of the controversy lies on whether or not to market the drug to women sixteen years or older, but seeing how women are not even close to being fully developed at age sixteen, the drug should not be available to them because they are more likely to use the drug improperly. </4: 3.9.1, 6.3.4>

<5: 7.3.1.1>Another way to regulate the distribution of Plan B is to put strict rules behind the buying and selling of the over-the-counter product, and then women would have to take the drug more seriously.</5: 7.3.1.1> <6: 6.6.3>The agency should use the same process of enforcement as tobacco products because there are strict rules and regulations that distributors have to enforce or they would be out of business. If the Food and Drug Administration uses the same plan of action with the over-the-counter product of Plan B, then more people will understand the seriousness of the drug.</6: 6.6.3>

<7: 7.4.6, 8.6.4>Furthermore, one stipulation for the over-the-counter drug is not enough. If girls really needed the emergency contraceptive, they would find ways to get the OTC product even if their not eighteen years old. The over-the-counter product should be marketed in a single package and at a higher price than the regular distribution. Girls would find it harder to get an over-the-counter product if a single package costs were not within their price range. It would also be harder for women to take too many pills or overdoes, if the Plan B drug is sold in single packages. However, the prescription product should not be as expensive as the over-the-counter product and it does not have to be sold in single packages. If women are prescribed the emergency contraceptive from a licensed doctor or practitioner then they should not go through the hassle that those who buy the over-the-counter product have to go through.</7: 7.4.6, 8.6.4>

<8: 2.1>Lester M. Crawford, the FDA Commissioner, has to make a major decision of whether or not to initiate rulemaking for the emergency contraceptive. He may have to weigh the political aspects but that should not be his major focus, instead he should focus more on the scientific and clinical evidence. If the Plan B, emergency contraceptive, really does cause more harm than help, then of course the drug should stay as a prescription, but if the drug does not show any proven evidence of harming those who consume the pill, then he should initiate rulemaking. He may however, have to take precautionary steps in the process by limiting sale of the over-the-counter product to a certain age group and selling the drug in single packages. </8: 2.1>

COMMENT NUMBER - 2005N-0345-EC14491

2005N-0345-EC14491 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Corlette, Chauncey

2005N-0345-EC14491 - TEXT

GENERAL

See Attachment

2005N-0345-EC14491-Attach-39.DOC

ATTACHMENT:

<1: 2.2>The process of proposed rulemaking and allowing the public to provide their input on key factors of today's important regulatory and policy questions and is a great privilege to have here in America. The trends of the nation are constantly changing and with the constant growth in the fields of medicine, technology, agriculture and so many more. There is a new burden placed on governmental agencies to make rules that apply to this growing nation.</1: 2.2> There are several questions that have been raised during the subject of allowing the plan B pill to the over the counter market, those questions were;

1) Can age be used as a criterion on which we decide whether a drug should be prescription or over-the-counter, as has been proposed in this case?

2) Can the prescription and over-the-counter version of the same drug be marketed in a single package?

3) In addition, if we do use age as the only criterion on which we decide whether a drug is sold as a prescription product, or an over-the-counter product, how, as a practical matter, would such a limitation be enforced?

4) In the Plan B application, we are grappling not with the same question but with a different question: whether we can have the same molecule exist as both a prescription and over-the-counter product for the SAME indication?
5)And if FDA were to attempt to limit sale of an over-the-counter product to a particular sub population, would FDA be able to enforce such a limitation as matter of law, and could it do so as practical matter and then how?

This paper will answer the listed questions, but not in the listed order.

The question was posed Question #2) Can the prescription and over-the-counter version of the same drug be marketed in a single package? <2: 8.1, 8.3.1>The prescription and the over-the-counter version of the same drug can be used and marketed in the same package only if the product is labeled properly. The FDA has very rigid rules for labeling for over-the counter drugs. The prescription and the over-the-counter version would need to adhere to the rigid rules of labeling; Drug Facts, Active ingredient, Purpose, Use(s), Warning, Do not use , Ask a doctor before use if you have, Ask a doctor or pharmacist before use if you are ,When using this product, Stop use and ask a doctor if ,Pregnancy/breast-feeding warning, Keep out of reach of children/Accidental overdose warnings, Direction , Other information, Inactive ingredients, and Question(Optional) and also have a statement on the package addressing the fact that the drug's intended use is safe for women 17 years of age and older without a prescription and for younger females they would require a licensed physician to write a prescription for the drug.</2: 8.1, 8.3.1>

The question of having the same packaging for a drug leads to Question # 4) whether we can have the same molecule exist as both a prescription and over-the-counter product for the SAME indication? <3: 3.9.1, 6.3.4>Currently the FDA allows the same molecule to be sold as a prescription product and an over-the-counter product, but there is a meaningful difference in the way the two products are used. Understanding that and the previous precedent was if a drug was unsafe for any public it would be classified as a prescription drug. The precedent would have to change, to serve the majority of the population it is purposed for, the majority of women would be able to benefit from this drug and be unsafe for a small sub-population. The drug will have a meaningful difference in being safe and appropriate for women 17 years of age and older. This Plan B drug is relatively safe for the majority of the public which is women 17 years of age and older the sub-population of minors until the age of 16 would be the only ones that the drug use would be inappropriate for without the consent of a doctor.</3: 3.9.1, 6.3.4>

Since age is a major issue with the use of the plan B drug it relates to Question # 1) <4: 6.3.4, 6.6.3>Can age be used as a criterion on which we decide whether a drug should be prescription or over-the-counter, as has been proposed in this case? Yes, there is already a precedent of the government regulating items based on age regarding alcohol and cigarettes. In today's markets there are controlled substances and items that have regulations based on age. The examples of which are alcohol and cigarettes both have had age limits set by the federal government. Alcohol and cigarettes, both are products that are sold publicly with only burden to prove, which is age. The reason of doing so is that some items take a certain maturity that hopefully comes with age to govern whether one should use the item and the amount of the item that one should use. </4: 6.3.4, 6.6.3>

The following questions ask how the age limit would be enforced in practical ways. Question # 3) In addition, if we do use age as the only criterion on which we decide whether a drug is sold as a prescription product, or an over-the-counter product, how, as a practical matter, would such a limitation be enforced? And Question # 5)And if FDA were to attempt to limit sale of an over-the-counter product to a particular sub population, would FDA be able to enforce such a limitation as matter of law, and could it do so as practical matter and then how?<5: 3.8.2, 7.4.1> Ways to enforce the limitation of age would to sell the drug behind the counter. The creation of behind the counter option in the United States would alleviate safety concerns between the availability of over the counter drugs to the public without any kind of professional conciliator. Pharmacists would be able not only limit the amount of drugs and keep track of buyers but also to provide counseling prior to administering the drug. The matter of law is making it mandatory for the drug to be sold behind the counter, having the pharmacist describe the drug and its side effects, having the persons who purchase the drug to agree to sign for it and present identification with their age on it. This would enforce the regulations for being able to sell the drug. There is a growing need for behind the counter drugs. For example; There has already been a push to have drugs that contain pseudoephedrine (ex. Sudafed), as their active ingredient, behind the counter because they are used to make crystal methamphetamine, an illegal drug. Having behind the counter drugs would allow effective medications that are relatively safe to be used in proper ways and available to the public. </5: 3.8.2, 7.4.1>

<6: 1.1>In a changing and growing society with a new self- care movement becoming more and more popular, the FDA is faced with a challenge to set new precedents to serve the majority of people instead of small sub-populations also to incorporate measures of safety by introducing new safe guards like behind the counter drugs. The changes would not only effect the decision of allowing the plan B drug to be introduced to the over-the counter market but many other drugs to maintain the health of United States citizens and allow drugs that are safe and effective to serve their purpose.</6: 1.1>

COMMENT NUMBER - 2005N-0345-EC14598

2005N-0345-EC14598 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Garden, Nicole

2005N-0345-EC14598 - TEXT

Issue Areas/Comments

<1: 1.2.1, 3.3.3>Part of the reason the birth control pill is marketed as a prescription and not an over-the-counter product is because of the many dosages, forms, and active ingredients it comes available in, which require dosing by a medical professional such as a physician, and monitoring to ensure effectiveness.

Because the emergency contraceptive is a standardized one-time dose, these factors do not come into play.</1: 1.2.1, 3.3.3>

GENERAL

<2: 1.2.1>Many of the reasons surrounding blocking the much-lauded Emergency Contraceptive Pill are related to Right-To-Life movements and the anti- choice agenda. These individuals in groups attempt to restrict the personal freedoms of women using proven, safe, effective birth control methods such as the Pill and Plan B, in the hopes of producing an unwanted pregnancy. Morally, these groups claim to be 'pro-life', but a lack of availability of these products (and the incredible cost to the state and otherwise of surgical abortions that must then be performed, which many low-income women cannot afford, when they could have afforded Plan B over the counter,) results in a high birth rate among impoverished women, further increasing loads on the social safety net, further impoverishing these communities as a whole, and guaranteeing an all-around poor quality of life for these children and their mothers. Approving Plan B for use over the counter would help drive down the astonishing abortion rate. Even the anti-choice movement cannot argue with a dropping abortion rate.</2: 1.2.1>

COMMENT NUMBER - 2005N-0345-EC146

2005N-0345-EC146 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Steele, Robert

2005N-0345-EC146 - TEXT

Issue Areas/Comments

<1: 3.1, 3.3.3>If 503(b) does not allow for the simultaneous marketing of a drug based on age or other factors, it should be amended. Precedences exist for such substances such as alcohol and tobacco products to be marketed based on age. The purchase of other non-ingestible items are certainly marketed by age, mental competency, criminal convictions, etc.. This is not a difficult and/or complexed procedure.</1: 3.1, 3.3.3>

<2: 3.1>This too is not a difficult or complexed task. If an amendmentis - based on changing circumstances warrants - obvious and needed, than the change(s) should made based on procedural issues and not politics or ideological leanings.</2: 3.1>

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

I do not have sufficient insight to warrant commenting on this issue.

C. If so, would a rulemaking on this issue help dispet that confusion?

<3: 5.1, 5.5>Certainly greater clarification and less ambiguity is always a plus. 503(b) does not have to be fit for all issues, amendments - with future consolidation - are appropriate.</3: 5.1, 5.5>

<4: 6.2, 6.5.1>"Enforcement" should not be the FDA's primary responsibilty in these cases - rulemaking is.</4: 6.2, 6.5.1> <5: 7.3.1.4, 7.4.1>Rules governing the OTC and precription sale of certain drugs are guidelines for the distributors and retailers, it is they who must determine how this will occur. If they fail, the FDA has grounds for action, possibly to cease distribution until remedial action is taken to resolve the problem. However, I doubt that this would be necessary since manufacturers benefit a lot more from sales than from a loss of their ability to sell. OTC and prescription drugs can be simultaneously sold from behind the counter to eligible customers.</5: 7.3.1.4, 7.4.1> <6: 6.2, 6.5.1>At issue is whether the eligible customer distributes the drug to his or her child - as long as the drug is deemed safe - this is outside of the realm of FDA jurisdiction.</6: 6.2, 6.5.1>

B. If it could, would it be able to do so as practical matter and, if so, how?

<7: 7.1, 7.4.1>Very simply. By distribution of the drug from the pharmacist's store room, after he or she has determined that the buyer is eligible to make the purchase. This is already in effect for many products being sold in our pharmacies.</7: 7.1, 7.4.1>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<8: 6.6.3, 8.1>Of course they can. The customer is buying an OTC product which has a buyer's stipulation. Think tobacco products and alcohol. If a doctor prescribes the use of the drug (which is commonly OTC for a certain age group and above)than handing the customer the same product in the same package (accompanied by the pharmacist's normal instructions and packing) is not a mind bending issue.</8: 6.6.3, 8.1>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<9: 9.1.1>It would be inappropriate if the sale was made to an ineligible customer or an ineligible (say with age restrictions) customer who does not have a valid doctor's prescription. If it were possible for a person of authority to "prescribe/authorize" the sale of cigarettes to a minor, simply the seller would hand them the Marlboro of their choice.</9: 9.1.1>

GENERAL

<10: 1.2.1, 2.1>I'm responding to these questions as a result of recent FDA decisions regarding Plan B. The issue here really isn't how do we make sales to authorized buyers only... there are simple and obvious answers to this procedural question... the issue really feels like personal ideologies and/or political-ideology. The scientific and health related facts seem to be in - the conclusions (at this point in time)are that Plan B post-intercourse anti-conceptional drugs are safe. The FDA's unbiased ruling(s) should track with the scientific evidence unless otherwise refuted by competent counter-conclusions. Birth control is a personal decision only. As much as certain fundamentalist groups would like to dictate their beliefs on to others, that is unacceptable, as sure as I am that rules made contrary to their beliefs would be unacceptable to them. The FDA needs to follow the guidances provided by their doctors and researchers and shy away from ideological pressures coming from any direction.</10: 1.2.1, 2.1>

COMMENT NUMBER - 2005N-0345-EC147

2005N-0345-EC147 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Loomis, Shirley

2005N-0345-EC147 - TEXT

Issue Areas/Comments

<1: 3.1>Yes, provided the drug is safe for distribution.</1: 3.1> <2: 1.2.1>Items such as Plan B have an impact on "quality of life," and if someone under 16 is seeking it, they are either already a child at risk for whom life is very challenging, or for some reason they are not in a position of being able to seek the assistance of their parents. As a parent, I want my children to always be able to come to me but more importantly I want them to be able to get what they need in a crisis through whatever means in available.</2: 1.2.1>

See above.

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<3: 4.1>There's significant confusion regarding all regulations. It's what keeps your lawyers working.</3: 4.1>

C. If so, would a rulemaking on this issue help dispet that confusion?

<4: 5.2>No. You will not dispel confusion. You may just simply be better able to serve the American public.</4: 5.2>

<5: 6.2, 6.7, 7.5.3>No you would not necessarily be able to enforce it but there are many unenforceable laws. You would however be putting forth a best efforts practice.</5: 6.2, 6.7, 7.5.3>

B. If it could, would it be able to do so as practical matter and, if so, how?

See above.

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<6: 8.2, 8.6.2>They should be packaged differently to help alleviate confusion for those responsible for handling them.</6: 8.2, 8.6.2>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

See above.

GENERAL

See above.

COMMENT NUMBER - 2005N-0345-EC148

2005N-0345-EC148 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Scott, Cindy

2005N-0345-EC148 - TEXT

Issue Areas/Comments

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

THIS SEEMS LIKE BS TO ME. <1: 3.9.1, 8.1, 8.8>I ALREADY RECEIVE CLARITIN (LORATADINE) 10 MG BOTH VIA PRESCRIPTION OR I CAN BUY IT OVER THE COUNTER. I DON'T THINK THERE IS A PROBLEM WITH SELLING THE PRODUCT IN THE SAME PACKAGE.</1: 3.9.1, 8.1, 8.8>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<2: 9.2.2>NONE</2: 9.2.2>

GENERAL

<3: 1.2.1, 2.1>I find it to be an extreme disservice to women and shame on the FDA that the Plan B pill is not available over the counter. Women - particularly adult women in the United States should have had access to this a long time ago. Please STOP ALL THIS BEAURACRATIC BS AND approve this reproductive health care option ASAP. </3: 1.2.1, 2.1>

sincerely,
Cindy Scott

COMMENT NUMBER - 2005N-0345-EC15

2005N-0345-EC15 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Marshall, Laura

2005N-0345-EC15 - TEXT

Issue Areas/Comments

<1: 3.1, 3.8.1>Codifying an interpretation can only help--make it clear exactly why and when a drug is being marketed OTC and Rx at the same time, and make it clear that the reasons are not political but medical.</1: 3.1, 3.8.1> <2: 3.9.1>Ibuprofen, ranitidine and other histamine receptor agonists, many drugs are currently sold OTC and prescription, but the issue there is about dosage, not a moral determination.</2: 3.9.1>

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<3: 4.1>I would say so; confusion and rumor, not to mention bad PR for the FDA.</3: 4.1>

C. If so, would a rulemaking on this issue help dispet that confusion?

<4: 5.1, 5.3.2>Yes. Make it clear what the determiners are of such decisions; that will make it easier on the FDA and clearly more of an issue of fact than politics.</4: 5.1, 5.3.2>

<5: 7.2, 7.5.3>As a matter of law, perhaps, but fake IDs and passing on of a prescription legally purchased would make the reality different.</5: 7.2, 7.5.3> <6: 6.5.4>And the likelihood is that making it harder to get for a specific subpopulation would engender lawsuits, more court cases, and further confusion as non-medical angencies and entities enter into the process.</6: 6.5.4>

B. If it could, would it be able to do so as practical matter and, if so, how?

See Above.

GENERAL

<7: 1.2, 2.1>Please try to keep politics out of the drug-approval decision-making process. I don't know the FDA charter, or the regulations binding its decision, but my guess is that nowhere in those documents is there any requirement that so-called moral factors be taken into account. There are moral arguments on both sides of this issue, and the best middle ground is factual and scientific when the matter is, itself, a factual and scientific matter. Is the drug safe for the population it will be sold to? Is it effective? Is it, perhaps, already available off-label? Those are the questions the FDA should answer, not whether it's either moral to sell or politically expedient.</7: 1.2, 2.1>

COMMENT NUMBER - 2005N-0345-EC155

2005N-0345-EC155 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Lamotte, Diane

2005N-0345-EC155 - TEXT

Issue Areas/Comments

<1: 3.1>Yes, I believe a rulemaking is in order.</1: 3.1> <2: 3.9.1>It doesn't seem too different from a medication being OTC in one case and not being OTC when combined with something else - especially when that something else is also OTC. Note Guaifenesin - long acting vs short, with or without a decongestant. Patients ask us why these items are prescription but can be bought separately OTC when combined.</2: 3.9.1>

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<3: 4.3.2, 7.1>I believe that health professionals and consumers expect the FDA to make a decision. Also they expect that the FDA can make any decision - and we will of course comply, whatever it is - even if it is novel.</3: 4.3.2, 7.1>

C. If so, would a rulemaking on this issue help dispet that confusion?

<4: 5.1>Yes, just give us the rulemakeing.</4: 5.1>

<5: 6.1>I believe that the FDA can enforce whatever it wants or needs to.</5: 6.1> <6: 6.6.1>Pharmacies currently comply with a multitude of regulations and policies. I manage a small pharmacy at a student health clinic and have no space for OTC self selection (or payment). Therefore, as a matter of policy, we pharmacists put OTC's into our Rx computer system and house them inside our pharmacy - so that the patient has to request the OTC item. We have personalized records on everyone regarding Rx and OTC medications. This is great for medication review and counseling. Additionally, I have practiced pharmacy in 3 different states. The pharmacists comply with both federal and state regs. The state regs change from state to state and we keep the records as required - logs for needles and syringes - C-V cough medicines can be signed out in some states - whatever the ruling, we'll comply.</6: 6.6.1>

B. If it could, would it be able to do so as practical matter and, if so, how?

<7: 3.8.2, 7.4.1>I visited Ontario, Canada and saw that they had a form to fill out and keep regarding EC. Of course, Canada already has that third class of "OTC, but limited and behind the counter", where patients must request the medication. We have a similar system in California, where pharmacists can prescribe and dispense EC. This works very well - if you have enough counseling space in your pharmacy.</7: 3.8.2, 7.4.1> <8: 7.1>Whatever you decide will be what is complied with.</8: 7.1> <9: 7.4.4>How about checking ID like for alcohol purchasing</9: 7.4.4>, <10: 7.4.6>or accepting implied truth of asking for the patient's birthday and believing them.</10: 7.4.6> <11: 7.5.3>Obvoiusly, if patients over 16 years of age can get it OTC, then it will be easy to acquire and anyone old enough can get it and give it to whomever they choose.</11: 7.5.3>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<12: 8.1>I think it is perfectly fine to use the same packaging. The patient will benefit from the best packaging whether they are 15 or 35.</12: 8.1> <13: 8.8>Also, the packaging is the same for C-V cough medicines that are prescription in some states but behind the counter in other states, where patients sign a special book.</13: 8.8>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<14: 9.2.2>Don't know of any</14: 9.2.2>...

GENERAL

<15: 1.2.1>It seems to me like the United States is behind the eight ball on this one. Many other developed countries have EC OTC - there is precidence elsewhere - we are not re-inventing the wheel here. I know that women have sex (what a surprise!) and either have a problem with their contraception or, the couple didn't plan ahead. The woman should not be the only responsible party here - it takes two to tango. I help women every day avoid abortion, by providing contraception and EC. I would think that every health care provider would want to join me! I am sure you are aware of the JAMA article about access to EC that points out that promiscuity is not increased by the availability of EC. And abortion rates have been reduced since EC has been available. Our pregnancy numbers have reduced here at UC Santa Cruz when we began providing EC through the pharmacy. You can't argue with success! </15: 1.2.1>Thank you for the opportunity to comment.

COMMENT NUMBER - 2005N-0345-EC1565

2005N-0345-EC1565 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Yao, Yvonne

2005N-0345-EC1565 - TEXT

Issue Areas/Comments

<1: 1.2.1>Although I believe that OTC access to all age groups would benefit the individual as well as society</1: 1.2.1>, <2: 6.1, 6.6.3>I also see that age limited access is used in the sale of other products e.g. tobacco and alcohol. Therefore it seems that regulation by law would be possible as it has for these other products.</2: 6.1, 6.6.3>

B. If it could, would it be able to do so as practical matter and, if so, how?

<3: 7.1, 7.4.1, 7.4.4>It could be handled like alcohol and tobacco, but perhaps by the pharmacist instead of the general retail clerk. For patients 18 or older, a picture id would allow purchase; for patients under 18, a prescription would be required. (Those without photo id might prefer to get a prescription from their doctors.)</3: 7.1, 7.4.1, 7.4.4>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<4: 8.1, 8.4.1>As long as the product is the same, it seems more "truthful" to package it in the same manner. It avoids the impression that one product is better or stronger.</4: 8.1, 8.4.1>

GENERAL

<5: 1.2.1>Although it is possible to sell this product differentially to different types of patients, given that the product is safe and effective in younger as well older women, it would be preferable to sell it to all women over the counter to reduce barriers to access. Younger woman are perhaps more likely to require confidentiality and also are more likely to be intimidated by the need to speak to a person of authority. </5: 1.2.1>

COMMENT NUMBER - 2005N-0345-EC15687

2005N-0345-EC15687 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Academy of Managed Care Pharmacy

2005N-0345-EC15687 - TEXT

Issue Areas/Comments

The FDA has interpreted the language in section 503(b) of the Durham-Humphrey Amendments to allow marketing of the same active ingredient in products that are both prescription and OTC, assuming some meaningful difference exists between the two that makes the prescription product safe only under the supervision of a licensed practitioner. The key distinction in all current examples of products sold both OTC and by prescription is that there is some meaningful difference between the two products (e.g., indication, strength, route of administration, dosage forms). To date, the FDA has not allowed marketing of the same active ingredient in a prescription product for one population and in an OTC product for a subpopulation. However, the FDA has acknowledged that its interpretation of section 503(b) of the act has not been explicitly set forth in any of the regulations that discuss the process by which FDA classifies drugs as OTC or prescription.

AMCP does not believe that the FDA has the authority to allow marketing of the same product as both a prescription drug and OTC product. For a medication to be granted OTC status, it must have a wide safety margin, be effective, and bear labeling understandable to ensure proper use. The FDA must determine that the labeling provides enough information for safe use by the general public. If the FDA determines that a drug meets the above conditions to be granted OTC status, then the drug is considered safe enough to be sold without a prescription.

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

One question posed by the FDA in the Federal Register is whether, assuming that it is legal to market the same active ingredient in both a prescription and OTC product, the different products may be legally sold using the same packaging. The Academy believes that the two products must be sold in different packaging. On May 16, 2002, OTC drug manufacturers were required to begin using the new standardized label for OTC medicines. The following information must appear on the OTC label:
? The product?s active ingredients, including the amount in each dosage unit.
? The purpose of the medication.
? The uses (indications) for the drug.
? Specific warnings, including when the product should not be used under any circumstances, and when it is appropriate to consult with a doctor or pharmacist. The warnings section also describes side effects that could occur and substances or activities to avoid.
? Dosage instructions addressing when, how, and how often to take the medication.
? The product?s inactive ingredients, which is important information for those with specific allergies.

The FDA requires that this information be in a certain format with standardized headings and subheadings and requires that the information be presented with certain graphical features.

The FDA also has specific labeling requirements for prescription medications. A prescription drug product is deemed to be misbranded if, at any time prior to dispensing, its label fails to bear the statement ?Rx only? or ?Caution: Federal law prohibits dispensing without prescription.?

AMCP also recommends that the Rx and OTC products need to have two distinct National Drug Code (NDC) numbers. The NDC number is the commonly accepted code for identifying packages of drugs. It is a unique number that identifies the drug, strength and packaging and is the HIPAA-required identifier for drug product claims. To allow managed care organizations, other third-party payors and drug information database providers to properly differentiate the prescription and OTC products for claims adjudication, the product must have a distinct NDC number.

2005N-0345-EC15687-Attach-48.DOC
2005N-0345-EC15687-Attach-48.DOC

ATTACHMENT:

October 31, 2005

Documents Management Branch
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Re: Docket 2005N-0345

The Academy of Managed Care Pharmacy (AMCP) is pleased to provide comments to the Food and Drug Administration (FDA) on circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter (OTC) drug product.

The Academy of Managed Care Pharmacy (AMCP) is a national professional association of pharmacists and other health care practitioners who serve society by the application of sound medication management principles and strategies to achieve positive patient outcomes. The Academy's 4,800 members develop and provide a diversified range of clinical, educational and business management services and strategies on behalf of the more than 200 million Americans covered by a managed care pharmacy benefit.

<1: 3.3.2, 3.9.1>The FDA has interpreted the language in section 503(b) of the Durham-Humphrey Amendments to allow marketing of the same active ingredient in products that are both prescription and OTC, assuming some meaningful difference exists between the two that makes the prescription product safe only under the supervision of a licensed practitioner. The key distinction in all current examples of products sold both OTC and by prescription is that there is some meaningful difference between the two products (e.g., indication, strength, route of administration, dosage forms). To date, the FDA has not allowed marketing of the same active ingredient in a prescription product for one population and in an OTC product for a subpopulation. However, the FDA has acknowledged that its interpretation of section 503(b) of the act has not been explicitly set forth in any of the regulations that discuss the process by which FDA classifies drugs as OTC or prescription.</1: 3.3.2, 3.9.1>

<2: 3.3.2, 6.2>AMCP does not believe that the FDA has the authority to allow marketing of the same product as both a prescription drug and OTC product. </2: 3.3.2, 6.2> <3: 3.3.2, 6.5.1>For a medication to be granted OTC status, it must have a wide safety margin, be effective, and bear labeling understandable to ensure proper use. The FDA must determine that the labeling provides enough information for safe use by the general public. If the FDA determines that a drug meets the above conditions to be granted OTC status, then the drug is considered safe enough to be sold without a prescription.</3: 3.3.2, 6.5.1>

One question posed by the FDA in the Federal Register is whether, assuming that it is legal to market the same active ingredient in both a prescription and OTC product, the different products may be legally sold using the same packaging. <4: 8.2>The Academy believes that the two products must be sold in different packaging. </4: 8.2> <5: 8.5.1>On May 16, 2002, OTC drug manufacturers were required to begin using the new standardized label for OTC medicines. The following information must appear on the OTC label:
The product's active ingredients, including the amount in each dosage unit.
The purpose of the medication.
The uses (indications) for the drug.
Specific warnings, including when the product should not be used under any circumstances, and when it is appropriate to consult with a doctor or pharmacist. The warnings section also describes side effects that could occur and substances or activities to avoid.
Dosage instructions addressing when, how, and how often to take the medication.
The product's inactive ingredients, which is important information for those with specific allergies.

The FDA requires that this information be in a certain format with standardized headings and subheadings and requires that the information be presented with certain graphical features.

The FDA also has specific labeling requirements for prescription medications. A prescription drug product is deemed to be misbranded if, at any time prior to dispensing, its label fails to bear the statement "Rx only" or "Caution: Federal law prohibits dispensing without prescription."</5: 8.5.1>

<6: 8.5.3>AMCP also recommends that the Rx and OTC products need to have two distinct National Drug Code (NDC) numbers. The NDC number is the commonly accepted code for identifying packages of drugs. It is a unique number that identifies the drug, strength and packaging and is the HIPAA-required identifier for drug product claims. To allow managed care organizations, other third-party payors and drug information database providers to properly differentiate the prescription and OTC products for claims adjudication, the product must have a distinct NDC number.</6: 8.5.3>

Therefore, although the Academy believes that an identical medication should not be approved in both a prescription and OTC form, if such a decision is made, the Academy believes the prescription and an OTC medication must be sold in different packaging in order to be in compliance with existing regulations and to allow proper claims adjudication.

AMCP appreciates the opportunity to comment on this extremely important issue. If you have any questions, please contact Judith A. Cahill, AMCP Executive Director, at (703) 683-8416 or at jcahill@amcp.org.

Sincerely,

Judith A. Cahill
Executive Director

COMMENT NUMBER - 2005N-0345-EC15690

2005N-0345-EC15690 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Association of American Physicians & Surgeons

2005N-0345-EC15690 - TEXT

GENERAL

See Attachment

2005N-0345-EC15690-Attach-49.TXT

ATTACHMENT:

Comments re: Docket No. 2005N-0345, RIN 0910-AF72
Drug Approvals: Circumstances Under Which an Active Ingredient May be Simultaneously