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FDA Simultaneous Marketing ANPRM

Bracketed Comment Letter Report

COMMENT NUMBER - 2005N-0345-EC654

2005N-0345-EC654 - STRUCTURED DATA ELEMENTS

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

2005N-0345-EC654 - 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: 3.1>Yes, if the benefit is clearly defined to those who would benefit from such an interpretation.</1: 3.1>

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

<2: 4.1, 4.3.4>Yes, when applied to the particular application concerning "Plan B".</2: 4.1, 4.3.4>

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

<3: 5.1, 5.3.2>It would help to clear up the issue regarding the controversy over age of the women and why those older than 16 "benefit" from OTC status and those under 16 might be harmed by OTC status.</3: 5.1, 5.3.2>

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?

<4: 7.5.3>Enforcement would obviously be the main issue and should raise the question of the reality of those doctors who would make such drugs available under pressure from parents of minor women who may have conceived a child.</4: 7.5.3>

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

<5: 7.1, 7.5.3>No, it would not be able to monitor the use of such drugs adequately as a practical matter.</5: 7.1, 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?

<6: 8.1, 8.9>It would not make a difference if the packaging contained language that indicated that two applications existed for the same product.</6: 8.1, 8.9>

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 question would be resolved by the debate in a rulemaking discussion.</7: 9.3>

GENERAL

GENERAL
<8: 1.2.4>
By all means the product in question should be correctly termed an abortifacient, since it can act to prevent the implantation of a fertilized egg into the uterine wall, and the product labeling should contain such information. This raises the question as to why it was approved in the first place since it is a lethal drug. </8: 1.2.4>

COMMENT NUMBER - 2005N-0345-EC66

2005N-0345-EC66 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Baird, Debora

2005N-0345-EC66 - TEXT

Issue Areas/Comments

Yes

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?

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

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

<2: 4.1>Yes</2: 4.1>

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

<3: 5.1>Yes</3: 5.1>

<4: 6.1>Yes</4: 6.1>

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

<5: 7.4.1, 7.4.4, 7.4.6>Allow pharacists to card those purchasing the drugs and the purchaser must sign a form stating "met age requirements". </5: 7.4.1, 7.4.4, 7.4.6><6: 7.4.5>Recourse for illegal purchase can be turned over to the local authorities for processecution</6: 7.4.5>.

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?

<7: 8.2, 9.1.1>No, different strenghts of product, different and separate packaging.</7: 8.2, 9.1.1>

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

<8: 9.1.1>None as long as "Plan B" Morning After pill is sold in a different strength and dosage, they are not the same.</8: 9.1.1>

GENERAL

<9: 1.2.1>PLEASE ALLOW THE OVER THE COUNTER SALES OF PLAN B (MORNING AFTER PILL). THIS WILL REDUCE THE NUMBER OF ABORTIONS AND GIVE WOMEN THE FREEDOM OF CHOICE THEY SHOULD HAVE. </9: 1.2.1>

THANKS!

COMMENT NUMBER - 2005N-0345-EC668

2005N-0345-EC668 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Vrankar, Anna

2005N-0345-EC668 - TEXT

Issue Areas/Comments

<1: 3.2, 3.3.2>No, if an active ingredient needs the supervision of a physician because of potential side effects, drug interactions, or because there might be physical conditions which would render taking such an ingredient unsafe, it should remain "prescription only"</1: 3.2, 3.3.2>

No, see above

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

<2: 4.2>no</2: 4.2>

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

<3: 5.5>only if the rule made it clear that if a prescription is required, it is universally required.</3: 5.5>

<4: 6.2>NO</4: 6.2>!<5: 6.6.3, 7.5.3> Is the ban on tobacco sales to minors enforeceable? Absolutely not.</5: 6.6.3, 7.5.3>

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

<6: 7.2>NO</6: 7.2>

GENERAL

<7: 1.2.3>Please protect our children's health! Keep these potentially dangerous prescription drugs available by prescription only</7: 1.2.3>

COMMENT NUMBER - 2005N-0345-EC671

2005N-0345-EC671 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Friedl, Mary Frances

2005N-0345-EC671 - TEXT

Issue Areas/Comments

no, the policy in effect now is adequate

<1: 3.2, 3.8.4>No, the policy in effect now is adequate. </1: 3.2, 3.8.4><2: 3.8.8>A change in this policy could result in decreased safety for OTC drugs. It would shift policy definition from the scientific to the political arena.</2: 3.8.8>

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

<3: 4.2>no</3: 4.2>

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

<4: 5.2>no</4: 5.2>.
2

<5: 6.2, 7.5.3>No, the population under limitation would simply approach the population not under limitation in order to purchase the drug through a third party. The decision of whether or not to give the drug to the subpopulation would be made, not by physicians, but by individual OTC purchasers.</5: 6.2, 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?

<6: 7.2>No.</6: 7.2>

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

<7: 9.1.2>Under all purposes.</7: 9.1.2>

GENERAL

This is one can of worms that the FDA should not be opening. <8: 3.8.4, 3.8.8>Under the current circumstances, some drugs are OTC and some are not because it is presumed that proper use of prescription drugs requires specialized knowledge that is not available to the general public. Without this knowledge, the public cannot truly give individual and personal consent to the possible consequences of the use of the prescription drug. It these drugs are made OTC, the only source of information available to consumers will be via inadequate package information or through the recommendation of the pharmacist. Any change in the current policy is going to negatively impact both the safety of the public and the role of pharmacists.Patients will become mere consumers and pharmacists will become amateur physicians. </8: 3.8.4, 3.8.8>

COMMENT NUMBER - 2005N-0345-EC677

2005N-0345-EC677 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Gordon, Jennifer

2005N-0345-EC677 - TEXT

Issue Areas/Comments

<1: 3.2>If this means that it should change its rules to allow the simultaneous marketing of 'Plan B' as an OTC and prescription drug, than no. See below.</1: 3.2>

Same as above. See below.

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

See below.

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

See below.

<2: 6.2>Without any real knowledge of law, I believe that a law must be reasonably enforceable to be real law.</2: 6.2> See below. <3: 6.5.3>Also, with respect to limiting OTC 'Plan B' to women over a certain age, how does this stand legally with the resistance to parental notification laws for minors who wish to obtain abortions? If, as many claim, it is illegal (violation of 'privacy') to require minors to notify parents before obtaining an abortion, and since they don't need a prescription to undergo a major surgical procedure, why should they not be allowed to decide on their own about taking 'emergency contraception?' It seems very contradictory.</3: 6.5.3>

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

<4: 7.2>Absolutely not. </4: 7.2><5: 6.6.3, 7.5.3>Just as minors easily purchase tobacco, alcohol and other drugs, 'prescription-only' for under 16/17 year old women would be a joke. Not only could minor women get friends and boyfriends to purchase this drug OTC, parents who wish to avoid the hassle and expense of going to the doctor would also purchase the drug for their daughters. </5: 6.6.3, 7.5.3><6: 7.6>Moreover, what would prevent men who are already breaking the law by having relations with minors from using this drug to cover up their crimes? This is already the problem with the striking down of parental notification laws for minors procurring abortions. The men who responsible for these pregnancies are able to pressure their victims into abortions without the parents ever knowing what is happening. This drug would make that abomination even easier.</6: 7.6>

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?

<7: 8.2, 8.5.4, 8.9>This question is grammatically confusing. Does it mean that the prescription and the OTC products will be sold together 'in the same package,' or that they will be sold separately in the same packaging? Since the former doesn't make any sense, I assume it's the later, in which case, I think it makes sense to sell them in different packages, so that there is some ability to distinguish between when the drug was procurred as a prescription and when it was procurred OTC. Since it would be illegal for minors to procure the OTC version of the drug, it seems important to be able to make this distinction.</7: 8.2, 8.5.4, 8.9>

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

Again, this question indicates that the first interpretation of "in the same package" above was correct. How is it possible to sell a prescription and a non-prescription in a single package?

GENERAL

Above, I answer the questions which have been posed by the FDA. <8: 1.2.4>What I have not stated so far is my objection to selling "Plan B" at all. "Emergency contraception," like the Pill, employees an abortifacient as its secondary effect. And as this "Plan B" is even stronger than the Pill, it would be causing many more early-term abortions.

It seems a gross violation of the FDA's purpose to approve the sale of a drug that is not used to heal or cure anything, but rather to take life. And as studies have already shown, the "Morning After Pill" has not succeeded in reducing the number of unintended pregnancies or abortions. It also provides absolutely no protection against STDs. It's another "safe-sex" fable that will lull even more young women (and men) into a dangerous mentality of sex without consequences. The FDA, by approving "Plan B" would be exposing women to more risks of health and life, not improving health care for women. Not only would it be immoral to approve the sale of this drug, it would also be pointless, as it has not been shown to have any practical value in the reduction of "unwanted" pregnancies. If there are strong moral reasons NOT to approve the drug and NO practical reasons to approve it, the FDA will be acting both immorally and illogically if it approves the sale of "Plan B." </8: 1.2.4>

COMMENT NUMBER - 2005N-0345-EC678

2005N-0345-EC678 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Socha, Kathleen

2005N-0345-EC678 - TEXT

Issue Areas/Comments

No. <1: 1.2.3>A drug so powerful that it can kill a person shouldn't be sold at all. But if you must, then by prescription only for all ages.</1: 1.2.3>

Yes. <2: 3.9.1>I take a drug sold both ways. I buy by prescription because my insurance pays for it that way.</2: 3.9.1>

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

<3: 4.2>No.</3: 4.2> <4: 4.4.2>I think the problem lies in trying to limit the age to purchase the OTC drug.</4: 4.4.2>

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

<5: 5.2>Only to you.</5: 5.2>

<6: 6.2, 6.6.3>You can't even prevent kids from buying cigarettes or alcohol. What are you thinking?</6: 6.2, 6.6.3>

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

<7: 7.2>Not possible.</7: 7.2>

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: 8.6.2>It would make it easier for the kids to get the right one.</8: 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?

<9: 9.1.1>When the product can kill a person. Adults die from this drug too.</9: 9.1.1>

COMMENT NUMBER - 2005N-0345-EC680

2005N-0345-EC680 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Schulz, Stan

2005N-0345-EC680 - TEXT

Issue Areas/Comments

<1: 3.2>No.</1: 3.2> <2: 3.8.8>This would open the floodgates for evermore trivial excuses to market products which have been judged dangerous enough to require professional oversight -- through a prescription.</2: 3.8.8>

No. This would open the floodgates for evermore trivial excuses to market products which have been judged dangerous enough to require professional oversight -- through a prescription.

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

<3: 4.5>No confusion regarding present practice; plenty of confusion over what may happen in the future.</3: 4.5>

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

<4: 5.2>No.</4: 5.2> <5: 5.4.2.2>It would only change a simple "esy/no" issue into a complex one requiring measurements (of age, for instance) or status (married or not), and set the groundwork for requiring additional bureaucratic action (for instance, requiring proof of age)and the possibility of fiviolous lawsuits based on the decision of a drugstore clerk.</5: 5.4.2.2>

<6: 6.2, 6.5.4>Probably not. It would result in lawsuits challenging the right to restrict sales; challenging the appropriateness of the cutoff age, alleging age discrimination.</6: 6.2, 6.5.4>

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

<7: 7.2>No.</7: 7.2> <8: 7.5.3>As a practical matter, any young girl could find a friend over the age of 16 who could buy the drug and give it to the youngster. Also, any young MAN over the age of 16 would gladly buy the drug for his underage lover.</8: 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?

<9: 8.1, 8.4.1>Sure. The packaging would make no difference --- it's the person making the purchase who makes the difference.</9: 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?

<10: 8.9>There are not "two products". They would be the same with just different locations and sales restrictions.</10: 8.9>

GENERAL

<11: 3.3.2>Any product which has been judged sufficiently dangerous to warrant professional supervision via prescription -- should not be presented to the public without such protection. </11: 3.3.2><12: 7.5.3>It opens the product to many forms of abuse -- purchase of the product by one qualified person for the use of another unqualified person; purchase of multiple packages of the product for over-use "just in case"; purchase of the product with intent to resell it at a profit to an unqualified person, etc. </12: 7.5.3>

COMMENT NUMBER - 2005N-0345-EC691

2005N-0345-EC691 - STRUCTURED DATA ELEMENTS

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

2005N-0345-EC691 - TEXT

Issue Areas/Comments

I am not sure what the interpretation is. <1: 1.2.1, 1.2.2>I will say that I support OTC status. Short of that, I support a dual OTC/prescription status.</1: 1.2.1, 1.2.2>

I am not sure what the difference between "act" and "action" is - may I suggest including some background in "plain english" for those of us who are interested laymen, but not lawyers? Otherwise, see my answer for the first question.

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

<2: 4.1>Yes - I am not even sure what it is!!</2: 4.1>

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

<3: 5.1>It would seem so, although I do not know what the ramifications of such a rulemaking would be.</3: 5.1>

<4: 6.1>Yes, I believe so.</4: 6.1>

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

<5: 7.1, 7.4.3, 7.4.4>I assume the "subpopulation" would be legal minors, under the age of 16-18. The limitation could be enforced by having undercover "minors" attempt to purchase the product OTC. Such practices are engaged in voluntarily by some retailers, e.g. Wal Mart IDs purchases of spray paint and alertness aids.</5: 7.1, 7.4.3, 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?

<6: 8.1>This question is a little beyond my knowledge, but on the face of it, I believe so.</6: 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?

<7: 9.1.1>If it is determined that a special package, i.e. instructions designed to be easily understood and targeted to minors, is needed for the prescription package.</7: 9.1.1>

GENERAL

<8: 1.2.1, 1.2.2>Once again, I believe that per the original recommedation, this drug should have been given OTC status. Short of that, I would support a dual OTC/prescription status. </8: 1.2.1, 1.2.2>

COMMENT NUMBER - 2005N-0345-EC7

2005N-0345-EC7 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Dawson, Jennifer

2005N-0345-EC7 - TEXT

Issue Areas/Comments

<1: 6.1>Yes, the limitation would be easily enforceable.</1: 6.1> <2: 6.4.1, 6.6.3>Such limitations already exist for medicines like nicotine-replacement therapy, as well as for other controlled substances such as tobacco and alcohol.</2: 6.4.1, 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>Pharmacists could be required to check IDs for customers. If pharmacists can be trusted with dispensing addictive and potentially dangerous pharmaceuticals, clearly they can be trusted to check to ensure customers are of legal age.</3: 7.1, 7.4.1, 7.4.4> <4: 6.6.3, 7.4.3, 7.4.5>If there was concern that pharmacists were not carding customers, undercover operations could be used as they are with tobacco and alcohol, and fines could be levied.</4: 6.6.3, 7.4.3, 7.4.5>

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, 9.1.1>I see no problem with selling prescription and OTC medicines in the same package, so long as their distribution is controlled.</5: 8.1, 9.1.1>

GENERAL

<6: 1.2, 2.1>I hope that the FDA rules promptly on this issue. American women have been waiting too long for emergency contraception, which is clearly safe and effective, to be on drugstore shelves. </6: 1.2, 2.1>

COMMENT NUMBER - 2005N-0345-EC710

2005N-0345-EC710 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Devine, Naomi

2005N-0345-EC710 - TEXT

Issue Areas/Comments

<1: 3.8.8>If the products are identical and for identical uses, all should be regulated.</1: 3.8.8>

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

<2: 4.1, 4.3.4>Yes, there is confusion. It is hard to understand why a drug should be prescription for some and over the counter for others.</2: 4.1, 4.3.4>

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

Perhaps.

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

<3: 7.2, 7.5.3>No. In practicality, this type of restiction would be nearly impossible to enforce.</3: 7.2, 7.5.3>

GENERAL

<4: 1.2.3>All other forms of birth control pills are available only by prescription. Why would this one be sold over the counter? It is dangerous and irresponsible of the FDA to allow a drug to be sold over the counter when the Agency has determined that it is unsafe for a large sub-population. Especially in this circumstance, where this sub-population would be highly interested in the drug. If this drug is unsafe for those under 17 -- it should not be sold over the counter at all.</4: 1.2.3>

COMMENT NUMBER - 2005N-0345-EC716

2005N-0345-EC716 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Hager, Joseph R

2005N-0345-EC716 - TEXT

Issue Areas/Comments

<1: 3.2>NO!</1: 3.2> 1. <2: 8.5.4>There is no way to control the dispensing that "medicine" if packaged the same.</2: 8.5.4> 2. <3: 1.2.3>As a parent, I object to a "birth control" drug being made available as an over the counter drug for my daughter under the age of 18 because I am still responsible for her health and safety, and her development, and a birth control drug available to her over the counter would usurp my parental authority</3: 1.2.3>. 3. <4: 7.5.3>Allowing an active medicinal ingredient simultaneously marketed in both a prescription drug and an OTC drug product would leave the use of the drug open to misuse/abuse.</4: 7.5.3>

No! See above answer.

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

Not able to make a knowledgeable response.

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

Unknown.

<5: 6.5.4>I say that the pharmicist/pharmacy/store is in danger of being prosecuted because they unintentionally/inadvertantly sell an OTC drug to some one who was authorized the drug only by prescription.</5: 6.5.4>

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

<6: 7.2>No!</6: 7.2>

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?

<7: 8.9>Are you asking a legal question of non-legally trained people?</7: 8.9>

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

<8: 8.9>Without a parent's approval.</8: 8.9>

COMMENT NUMBER - 2005N-0345-EC717

2005N-0345-EC717 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Gorini, Joseph

2005N-0345-EC717 - TEXT

Issue Areas/Comments

<1: 1.2>First, please consider whether or not the FDA should be answering this question with regard to Plan B. Plan B should not be considered to fall under the FDA's concern for 'health and safety.' See General Comment.</1: 1.2>

First, please consider whether or not the FDA should be answering this question with regard to Plan B. Plan B should not be considered to fall under the FDA's concern for 'health and safety.' See General Comment.

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

<2: 4.1>If the FDA applies section 503(b) it would ceate confusion by seeming to accept Plan B as falling under FDA's concern for 'health and safety.' See General Comment.</2: 4.1>

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

<3: 5.2>Rule making on this issue with regard to Plan B would confuse the proper understanding of 'health and safety.' Plan B should not be considered to fall under the FDA's concern for 'health and safety.' See General Comment.</3: 5.2>

What is the FDA's experience with other abortifacients?

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

<4: 7.2>No!</4: 7.2>

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?

I would hope not!

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>Always.</5: 9.1.2>

GENERAL

<6: 1.2>In and unusual exchange this week in the US Congress, among the highest ranking UN officials admitted that the term "reproductive health" does not include abortion, at least in the context of the recently decided Millennium Summit Declaration. The exchange came during a hearing of the US House Committee on International Relations when Congressman Chris Smith questioned Mark Malloch Brown, senior adviser to UN Secretary General Kofi Annan. Smith asked Brown three times if "reproductive health" included access to abortion. Brown finally admitted that it did not.</6: 1.2>

COMMENT NUMBER - 2005N-0345-EC73

2005N-0345-EC73 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Ricci, Stephen

2005N-0345-EC73 - 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>Yes</2: 4.1>

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

<3: 5.1>It is more likely</3: 5.1>

<4: 6.7>Not without a means to verify the end-user of the product, as is with a valid RX signed by a licensed practioner for a single patient</4: 6.7>

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

<5: 7.2>I do not believe it is likely even as a practical matter.</5: 7.2>

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, 8.8>This is the case with one particular ingredient: Meclizine 25mg tablets are currently either labeled for RX or OTC distribution. The package must be labeled accordingly, as so it cannot be produced by a manufacturer in 'the same package' unless it is one labeled for OTC</6: 8.2, 8.8>

GENERAL

<7: 1.2.3>I as a licesnsed healthcare practioner do not approve of the sale of Plan B as an OTC entity.</7: 1.2.3>

COMMENT NUMBER - 2005N-0345-EC76

2005N-0345-EC76 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Rosati, Lucia

2005N-0345-EC76 - TEXT

Issue Areas/Comments

<1: 3.8.5>I believe it is acceptable to consider drugs on a case-by-case basis.</1: 3.8.5> <2: 1.2>In the case of Emergency Contraception/Plan B, I can appreciate the concerns about selling to minors.</2: 1.2>

I believe that if a drug is considered safe when used approriately, it should be sold as over-the-counter -- period. <3: 7.4.4>If there are concerns regarding the age of purchasers/users, leave it up to the individual retailer to "proof" the person if they so wish. </3: 7.4.4><4: 1.2.1>I don't see any disadvantage, however, to an individual using Plan B even if they're 15 years old. At least, a pregnancy will not result, which is much worse.</4: 1.2.1>

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

<5: 4.1>Yes. </5: 4.1><6: 1.2.1, 2.1>The drug should have been allowed based on it's safety -- nothing else. You don't see cigarettes being sold prescription to minors, but over- the-counter to adults. And cigarettes are much worse. The only reason you are hesitating to rule on this drug is because of the religious concerns of certain segments of the population. I believe that that violates the rights of American women who would benefit from its availability.</6: 1.2.1, 2.1>

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

<7: 3.8.5>Maybe so; but again, I think each drug should be considered on a case-by-case basis. In most cases, I don't see why a drug would be safe only for certain people. Either it's safe or it isn't.</7: 3.8.5>

<8: 6.1>The FDA through the pharmacy chains would be able to enforce it just as they enforce any other prescription medication.</8: 6.1>

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

<9: 7.1>How does it normally enforce the sale of prescription drugs? However, the drug would have to merit regulation. </9: 7.1><10: 1.2.1>In the case of Plan B, there's no reason why it cannot be available over-the-counter to any woman seeking it, no matter the age.</10: 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?

<11: 8.1, 8.4.1>Certainly. I don't see why packaging would have to change. Only the manner in which it is sold would have to change.</11: 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?

<12: 9.2.2>I cannot think of any.</12: 9.2.2>

GENERAL

<13: 1.2.1>I think the time has come to make Plan B contraception available to women over-the-counter. This is a safe drug and would reduce the number of unwanted pregnancies, and therefore, the number of abortions. I urge you to act quickly on this. It has taken long enough and has been found to be safe.</13: 1.2.1>

COMMENT NUMBER - 2005N-0345-EC762

2005N-0345-EC762 - STRUCTURED DATA ELEMENTS

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

2005N-0345-EC762 - TEXT

Issue Areas/Comments

<1: 3.2, 3.9.1>The FDA has already approved the use of drugs in both simultaneous prescription form and over the counter form, ie. Claritin. I argue that such allergy drugs are still only used by allergy sufferers, not the entire population, and yet they are available for use by all.</1: 3.2, 3.9.1> <2: 2.1, 3.2>Denying the approval of Plan B as an over the counter drug, especially after being so overwhelming approved for such use in clinical recommendations, appears to be a direct (embarrassing) cow-tow to a particularly vocal political minority. No ruling is necessary if the panel on the FDA would take responsibility for their positions as scientists and attempt (and act) as objective voices for the health of the public (rather than the interests of lobbying groups, be they political or pharmaceutical).</2: 2.1, 3.2>

This question is the same as the previous question with minor change (act - action, marketed - market). My answer still stands.

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

<3: 4.2>No, there is not significant confusion.</3: 4.2> <4: 1.3, 2.1>Your interpretation of the 503(b) text is just an excuse to delay the approval of a safe drug for the OTC market (where was the need for clarity on 503(b) when truly dangerous drugs like Vioxx and Celebrex were so hastily approved?). In failing to rule objectively you disappoint your public and endanger their health.</4: 1.3, 2.1>

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

<5: 5.2, 5.4.2.2>I fear that rulemaking on this issue would only further codify the opinion driven barriers which prevent scientific recommendation from being heeded.</5: 5.2, 5.4.2.2>

<6: 6.2>No.</6: 6.2> <7: 6.5.4>Limiting the sale of an OTC product to a particular subpopulation (in this case, the "subpopulation" being HALF the population, ie. women) by making it prescription only is tantamount to discrimination.</7: 6.5.4>

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

<8: 7.2>It would not be able to do so as a practical matter. </8: 7.2>This question presupposes making an OTC drug prescription only is "a practical matter" when the drug is only used by a segment of the population. It may be argued that all drugs are only used by a segment of the population, when they so need them. This question also presupposes that the FDA's job is to regulate drugs for "practical matters". I find this presupposition appalling. <9: 1.2.1>I am challenged as to whether I should lose my faith in the FDA as an objective, regulatory commission with the best interests of the American public at heart. It is impractical to continue to keep a safe drug prescription only, especially when its effectiveness is so dependent upon a crucial time- window - 72 hours, but the sooner, the better. By continuing to keep Plan B as prescription only, you are patently interfering with the effectiveness of this drug, by making it difficult and time-consuming for the drug to be obtained by those who need it.</9: 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?

<10: 8.1>Yes they may legally sold in the same package. </10: 8.1><11: 8.9>In fact, a more useful law would be one preventing pharmaceutical companies from artificially inflating the price of either the OTC or prescription version.</11: 8.9>

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

<12: 9.2.2>I find no circumstances in which it would be inappropriate to do so.</12: 9.2.2>

GENERAL

<13: 1.2.1, 2.1>It is reprehensible that the FDA has delayed the approval of a drug (Plan B) that has been proven safe and highly recommended by clinicians for use over the counter. I dare to hope that the panel will grow a spine and rule on this and all other future drug recommendations from an objective motivation, untainted by politics or profit. In continuing to deny safe drugs, such as Plan B, on the market to those who need them, you are effectively endangering the health of the public.</13: 1.2.1, 2.1>

COMMENT NUMBER - 2005N-0345-EC77

2005N-0345-EC77 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Carlson, Brent

2005N-0345-EC77 - TEXT

Issue Areas/Comments

<1: 3.1>Yes.</1: 3.1> <2: 1.2.2>Access without a prescription in the 17 year old and above is reasonable and will help prevent unwanted pregnancies.</2: 1.2.2>

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

<3: 4.2>No.</3: 4.2>

<4: 6.1>Yes.</4: 6.1> <5: 7.1, 7.4.1, 7.4.4>You could either require identification at the point-of-sale or require dispensing by a pharmacist (with ID).</5: 7.1, 7.4.1, 7.4.4>

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

See "A".

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, 8.3.1>The "legend" would have to be modified to read "for patients under 17 years of age".</6: 8.2, 8.3.1>

GENERAL

<7: 1.2.2>This appears to be a compromise that will at least provide easy access to prevention of unwanted pregnancies for women 17 or older until a more effective "treatment" is approved.</7: 1.2.2>

COMMENT NUMBER - 2005N-0345-EC779

2005N-0345-EC779 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Macdonell, Megan

2005N-0345-EC779 - TEXT

Issue Areas/Comments

<1: 3.1, 3.9.1>There are many medications that have the same active ingredient available in both a generic/OTC method as well as through prescription. With that said I am also unaware of the guidelines by which these decisions are made, however I do not personally see it as a problem. I believe that there should be a "re-wording" of section 503(b).</1: 3.1, 3.9.1>

<2: 6.6.3, 7.4.1, 7.4.4>I believe that a controversial product like Planned B should be placed behind the counter (at the register) to control the buyers age of this product. I am from Oregon, and here our legal age to buy cigarettes is 16 years of age. I believe that if this product was kept behind the counters (literally) that this will prevent theft and the ID's of the buyer can be checked before the product can be purchased. If the consumer does not have a Drivers License or and ID with their birthdate on it, then I believe they should need a form of proper identification that includes their date of birth.</2: 6.6.3, 7.4.1, 7.4.4>

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

<3: 7.1, 7.3.1.2, 7.4.4>I do not believe that the process I described above is unpractical or difficult to accomplish. I believe that cashiers just need to be trained at looking for proper ID's (which generally they are) as well as the use of discretion while serving these consumers.</3: 7.1, 7.3.1.2, 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>I believe that they should be allowed to be sold in the same package.</4: 8.1> <5: 8.3.4>I also believe that perhaps the packages that are sold in stores should have information about the risks of this medication and facts about why this is called emergency contraception, and that it in no circumstance should replace normal contraceptive measures. The subpopulation under 16 who would get it through prescription will have their doctors explain these facts. So I do not believe that it would hurt to have an extra procautionary measure included in the OTC meds.</5: 8.3.4>

GENERAL

<6: 1.2.2>I believe that making the Planned B birth control available without a prescription to women age 16 and older is a progressive measure. I believe that the girls under 16 should seek a health practitioner for this medication so that they can be properly notified about the risks that are involved as well as the term "emergency". I believe this way, perhaps they can get the help they need, while also getting information about how to help their bodies and perhaps recieving another form of protection for the future.</6: 1.2.2> I also believe that perhaps the packages that are sold in stores should have information about the risks of this medication and facts about why this is called emergency contraception, and that it in no circumstance should replace normal contraceptive measures. The subpopulation under 16 who would get it through prescription will have their doctors explain these facts. So I do not believe that it would hurt to have an extra procautionary measure included in the OTC meds.

COMMENT NUMBER - 2005N-0345-EC788

2005N-0345-EC788 - STRUCTURED DATA ELEMENTS

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

2005N-0345-EC788 - TEXT

Issue Areas/Comments

Not in the case of Plan B.

<1: 3.2>No.</1: 3.2>

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

<2: 4.1>Yes.</2: 4.1>

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

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

<4: 6.1>Probably.</4: 6.1>

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

<5: 7.5.3>Very difficultly.</5: 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?

<6: 8.4.1>This is an absurd question: after some time people will know the way (ex. a friend or relative with the required age of 17 years) how they can buy it OTC and the different package for prescription will be of no use.</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: 9.1.2>Any.</7: 9.1.2>

GENERAL

<8: 1.2>One of the main arguments for providing an OTC version of Plan B and similar products is a presumed reduction in the number of needed pregnancy terminations of unwanted pregnancies. Similar products have been approved for OTC use in several countries in Europe (Great Britain, Belgium, France,...), many times with this same argument of reducing the absolute number of pregnancy terminations. In september 2000 Norlevo was introduced as an OTC product on the Belgian market. Now on a total population of 10 million persons more than 1OO.OOO units are used each year. The number of pregnancy terminations has increased significantly since then: 14923 in 2000, 16707 in 2003 (an increase of 21%). The number of OAC remained stable in that period and there was a major increase in pregnancy terminations in the 12-20year age group. Recent (unpublished, 2004-2005) numbers indicate an even higher increase. The same trend has been seen in Great Britain.</8: 1.2>

<9: 1.2>Is it possible to publish (or email) the review of scientific studies on wich the Center for Drug Evaluation and Research or CDER, has based its conclusion that the available scientific data are sufficient to support the safe use of Plan B as an over the counter product?

And what fysiologic argument is given to withhold it to women 16 years old and not to women who are 17 years and older?

Are there any large scale studies on the metabolic and cancerogenic long-term efects of these products included in this review?

In recent years there has been seen an increase in early (30-40years age group) and often very aggressive forms of breast cancer: have there been any studies undertaken to link the use of morning-after pills as one of the possible causes? </9: 1.2>

Thanks,

Thomas Phlips, MD

COMMENT NUMBER - 2005N-0345-EC793

2005N-0345-EC793 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Kuskey, Garvan

2005N-0345-EC793 - TEXT

Issue Areas/Comments

(See statement below in the comments section

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

<1: 4.1>yes</1: 4.1>

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

GENERAL

<2: 3.1, 3.10>If 5% testosterone -- a completely benign substance -- must be written on a triplicate prescription, then why not this more dangerous preparation?Or the reverse: if this drug can be marketed without a prescription to those over sixteen years of age, then why can't 5% testosterone be marketed to elderly men who need HRT? The FDA designated low-dose testosterone a dangerous drug specifically because of its abuse by body builders. And yet, body builders don't use 5% preparations. In fact, they can and do easily buy much more concentrated products in Mexico.</2: 3.1, 3.10> <3: 1.3>Because you have listed low-dose testosterone as a controlled substance, this relatively cheap substance is now priced beyond the reach of many senior men: up to $250 for a one month's supply. I recommend that you promptly de-list it so that those needing this soy-based bioidentical hormone can purchase it over the counter for closer to $25 for a one month supply. Or does that make too much sense?</3: 1.3>

COMMENT NUMBER - 2005N-0345-EC80

2005N-0345-EC80 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Cahoon, Clifton

2005N-0345-EC80 - TEXT

Issue Areas/Comments

<1: 3.2>no</1: 3.2>

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

<2: 4.3.4>That is hard to justify or explain. It is my opinion that medications which are prescription should not therefore have a simultaneous non- prescription status.</2: 4.3.4>

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

<3: 5.4.2.2>I think it should continue to stay legend vs non-legend and not allow a ruling which would not only put the particular drug at hand to be confusing but there would be too much leeway to allow multiple drugs be given OTC status.</3: 5.4.2.2>

<4: 3.8.7, 6.5.4>This is making it too confusing. I think they should not allow this subpopulation seperation legal. It presents too many future regulations, regulatory parties, audits, etc. Yes a drug may make OTC status but the monetary and regulatory burden placed therefore on the public would be enormous. The drug would in essence be able to be free of that burden while then the burden rests on taxpayers and retail workers to pay for this drugs audits and regulations. Very unwise when the drug is for such a limited population that the burden is then placed on the general public. Let the population for whom the product is designed for seek to carry the burden by seeking a physician visit and prescription given. This is a ridiculous request by a drug maker, it is obvious they will make the money, market the product and then pass the burden of regulation and audit to the taxpayer. Abuse.</4: 3.8.7, 6.5.4>

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

<5: 7.2, 7.5.2>No, no, no. I have explained my rationale above. They would place the burden on society as a whole for such a small population for whom it serves. It is not practical no matter how much the drug company said they would monitor it, in the end we would end up paying for it as taxpayers. Very inappropriate shuffle of burden.</5: 7.2, 7.5.2>

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, 9.2.2>Not at all.</6: 8.2, 9.2.2>

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

<7: 2.1, 3.8.8>This is a matter that the FDA must continue to monitor and not make a drug manufacturer the controlling party. Do not allow drugs with such specificity as being subpopulation separated to become the burden of all public buyers. The people who seek such specific medications must continue to seek to establish a physician/patient relationship or pharmacist/patient relationship where legal to do so in order to meet criteria. Let only those trained in health care specific to the disease decide the appropriateness of therapy, not allow the general public to make that determination. It is a shift of burden that must be kept with the FDA and regulated by legend drug rules, and not allowed to be made a public responsibility to determine appropriateness of therapy. It only opens a large decentralization of appropriateness of regulation, appropriateness, and cost. </7: 2.1, 3.8.8>

COMMENT NUMBER - 2005N-0345-EC81

2005N-0345-EC81 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Schmierer, Ann

2005N-0345-EC81 - TEXT

Issue Areas/Comments

<1: 3.2, 3.8.4, 3.9.1>I think there are a number of drugs available OTC that are similar and used for exactly the same indications as prescription drugs (i.e. Claritin OTC, Prevacid OTC), and there should be no distinction made between the interpretation for these drugs, so why the confusion on Plan B? I believe there is a very distinct political motivation behind this issue being raised. If the product is proven safe and effective by the FDA for OTC, it should be made available to consumers that want it.</1: 3.2, 3.8.4, 3.9.1>

No. See above comments. FDA has made their recommendation, so follow it.

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

<2: 4.4.2>I think it may be inappropriate for the public to make comments on "FDA's confusion" on the interpretation. I believe there are adequate historical cases and presidence for a number of OTC formulations and similar drugs only availble via prescription, all proven safe and effective by the FDA for dispensing to patients and consumers. This is a political position taken by the Commissioner and the office of HHS, and I believe he and the office should stand down and let the FDA do their job.</2: 4.4.2>

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

<3: 5.4.3>I am unaware of the definition for the word "dispet" in the English language that is worded in the question, and may be used intentionally to really incite "confusion". If the appropriate word was intended to be "dispel", I believe there are adequate rules within the Federal Register for the FDA to do it's job, and do not have a problem with their interpretation of what has been entered into the code of law governing FDA.</3: 5.4.3>

<4: 1.2.1, 6.5.4>If the FDA has ruled that this product is safe and effective for OTC designation, they should make the product available to customers. Do pharmacies (or the FDA) restrict the sale of condoms or contraceptive jelly to a 5 year old? Should pharmacies (or the FDA) restrict the sale of condoms or other contraceptive items to a 10 year old? At what age is it appropriate to sell OTC contraceptive items...who cares. If they are needed by a specific consumer, they have OTC designation, why should there be a gender bias against females that want this product? What about girls that are raped by a stranger, their brother, cousins or fathers that would like to have some control over their reproductive system? Give females the control their own decisions on this matter, especially when there is an FDA sancioned product available that is deamed safe and effective for OTC use.</4: 1.2.1, 6.5.4>

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

<5: 7.4.1, 7.4.4, 7.5.4>If the FDA Commissioner, Secretary of HHS, and the President would like to interfere in this FDA issue, and as a result there are restrictions placed on this product, I think the recent ruling on pseudoephidrine-containing pills being available as OTC, but in limited quantity and behind the counter at a pharmacy can make an example of how to deal with this situation. Make it available in a set limited quantity that can be obtained from a pharmacist by asking at the counter. If there is some age restriction imposed, then have the person produce proof of age, such as an ID card or driver's license to provide that information. I feel that by producing such information is an invasion of privacy as the pharmacist would know the identity and could possibly interfere with a personal matter by obtaining such information for an OTC product. Are there HIPPA restrictions on phamacy personnel having access to patient information (and interference with a request for an OTC drug) that can guide this train of thought?</5: 7.4.1, 7.4.4, 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?

<6: 8.3.1>Typically, OTC and prescription formulations have different packaging, and I believe it is appropriate to do so if it is deamed necessary to have pertinent health and usage information clearly displayed on the packaging. Typically, presription packages do not come with detailed use information, e.g. a pill bottle filled at a pharmacy, but pharmacies may provide additional information about the drug by including a drug package insert or sheet. In this particular case you may want to have clearly displayed information ON THE OUTSIDE OF THE PACKAGE on how to use the product (i.e. route of administration, etc.) so there is no confusion for someone that is considering the purchase of the OTC product and whether it is appropriate for them. There should be adequate information available, as for cold remedies, for people on certain medications or or have certain health conditions that it is not recommended for use.</6: 8.3.1>

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

<7: 9.1.1>See above comments concerning existing health conditions or medication that the person is taking that could jeopardize their health, or interfere with know medications (if that information is know at this time). Examples of an OTC product that have warnings are numerous, such as aspirin not recommended for those with a history of intestinal bleeding or clotting disorders, or cold remedies that can adversely affect asthma sufferers.</7: 9.1.1>

GENERAL

<8: 1.1>I consider the delay in the availability a blatant display of political interference by the FDA commissioner, the commissioner's office, the Secretary of HHS, and the president of the United States. I and many within the US public, believe the integrity of Secretary Leavitt, Commissioner Crawford, and the organizations they 'lead' are irreparably damaged by caving in to political pressure and presidential mandates. If people do not want to use this product for political or religious reasons, individual women have the right to make that choice. Many states have spoken on the issue and have drafted bills within their legislative bodies to make Plan B available to the consumers in their states. Large bodies of people have spoken through these state legislative actions, and their opinion on the availabilty of this product quite obvious.

I think it is time for Secretary Leavitt and Commissioner Crawford to stand up and support the scientific evidence provided and reviewed extensively by the FDA, support the lawful process outlined in the Federal Registry that guides FDA, stop interfering with a company's product for political reasons, and make this product available. The longer this drags on and the more delays imposed by the Secretary, Commissioner and President, the more damage you do to instituting a SCIENTIFICALLY-BASED FDA process, damage to commerce by interfering for political gain, discrimination against poor women by denying access to Plan B OTC, discriminate against women that do not have access to adequate healthcare (a doctor's needed prescription and payment of drugs) due to the lack of insurance, and risk the alienation of women of the United States. These delays and obstructions will only damage the reputation of the stated government individuals, and the organizations they are representing. </8: 1.1>

<9: 1.2.1>The law is clearly stated, the FDA has thoroughly reviewed the product's safety and efficacy, so stand down and let this product proceed to comsumers that choose to use it. Do not make this an issue of women wealthy enough to travel to states or countries where this product may be freely available in the future, or only those with medical insurance coverage. I believe this is a blatant discriminating act towards poor and uninsured women of the United States. Give these women OTC options that do not require a prescription that they do not have access to or the means to pay for as long as the product is safe and effective. Condoms and contraceptive jellies are not enough--bring this option to the the consumer, and let THEM make the choice. No one would be forcing anyone to use this product, but it should be made available to women that feel this treatment is appropriate and compatible with their health care. </9: 1.2.1>

COMMENT NUMBER - 2005N-0345-EC811

2005N-0345-EC811 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Camron, Kiera

2005N-0345-EC811 - TEXT

GENERAL

The comments below were published in the "Tallahassee Democrat" on September 9, 2005. The author is Kiera Camron, responding to an editorial by Mary Ann Lindley.

<1: 1.2.3>Mary Ann Lindley calls the morning-after pill, or ?emergency contraception? (EC), a ?blessing.? Apparently, her definition of ?blessing? and mine are opposites.

Many descriptions of the various methods of EC call these regimens ?mega-doses? of the chemicals found in daily birth control pills. (For example, the ?Plan B?EC kit?s two pills, to be taken 12 hours apart, contain the same amount of levonorgestrel that a birth control pill user would ingest in about 20 days.) It follows, then, that EC users could experience many of the same serious side-effects that birth control pill users can experience (blood clots, strokes, heart attack, tumors, even an increased incidence of sexually transmitted disease) and then some: add inconvenient nausea and vomiting and even the potentially fatal ectopic pregnancy. Women who have historically suffered from a variety of health issues or who smoke are more vulnerable to the dangerous side-effects of EC.

EC is also contraindicated for routine contraceptive use, so it?s not safe to use over and over again in the place of other contraceptives. But women?s lifestyle choices could be significantly altered if they have some sense of ?safety? because they perceive EC to be a ?back up.? Poor choices and risky behaviors are associated with sexually transmitted disease infection, including HIV, and particularly among people under age 25, where two-thirds of STD infection occurs. Some sexually transmitted diseases are viruses that a woman will carry with her for the rest of her life; some cause dramatic damage to women, including sterility and cervical cancer. EC provides no protection whatsoever against these sexually transmitted diseases.

EC doesn?t stop at harming women; it harms the most defenseless among us, newly conceived boys and girls. Although Ms. Lindley claims that EC does not cause very early abortions, the FDA and the Alan Guttmacher Institute say that it can interfere with the implantation of early embryos. Both concur that, among several mechanisms, EC may work by either interfering with an embryo?s movement through the fallopian tube toward implantation in the uterus or by changing the lining of the uterus, making it inhospitable to the embryo. That new life is lost to his or her parents, and to the world. What is worse, he or she is lost without anyone?s knowledge because EC proponents obscure the truth about this mechanism of the drug. </1: 1.2.3>

<2: 3.1, 3.8.3>Despite all of these risks, proponents are agitating (loudly) for these drugs to be made available over the counter, available without the advice of a medical professional who would provide vital education and assessment of a woman?s risk. The well-being of Americans is at stake; it is the FDA?s responsibility to ensure the involvement of medical professionals and prevent the over the counter sale of EC.

Planned Parenthood claims that EC will prevent 1.7 million unintended pregnancies and prevent 800,000 abortions each year in the United States, yet studies in the prominent medical journal The Journal of the American Medical Association and others in countries where EC has routinely been used for years show no change in pregnancy rates with over the counter availability of EC. So why the stubborn promotion of EC? What agenda could possibly justify the exploitation of American women?

I, for one, am thankful for the FDA taking the time to look more carefully at this dangerous drug. With any luck, they will conclude that over the counter EC is one ?blessing? America can do without.</2: 3.1, 3.8.3>

COMMENT NUMBER - 2005N-0345-EC813

2005N-0345-EC813 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Wagner, Patricia

2005N-0345-EC813 - TEXT

Issue Areas/Comments

<1: 8.6.2>If an active ingredient is marketed in both prescription and OTC forms the packaging and advertising should be clearly different. Assuming that people with no medical training can differentiate carefully nuanced differences invites an increase in drug induced adverse effects that will eventually lead to a distrust in the pharmaceutical industry by the general population.</1: 8.6.2>

<2: 3.1, 8.6.2>The FDA should issue an interpretation of section 503(b) that requires that when drugs are simultaneously marketed as both prescription and OTC their packaging and advertising must be so dissimular that the ordinary customer will identify them as two different products.</2: 3.1, 8.6.2>

<3: 6.6.3, 7.5.3>Over the last several decades we have had laws forbidding the purchase of tobacco and alcohol by those under age. It has been very difficult to enforce and is frequently circumvented by simply having an older friend or acquaintance make the purchase. As it has become increasingly common for adult men to seek out minor females as sex partners, how will they be prevented from purchasing OTCs and using coercion to convince their "girlfriends" to use them or even slipping them into their food or drink without their knowledge?</3: 6.6.3, 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?

<4: 8.5>It would seem to be an invitation for lawsuits against pharmaceutical manufacturers. </4: 8.5>

COMMENT NUMBER - 2005N-0345-EC82

2005N-0345-EC82 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Fogelgren, Katharine

2005N-0345-EC82 - TEXT

Issue Areas/Comments

<1: 1.2.1, 6.5.4>I am really struggling with your stance on this issue. Why was age 16 years first chosen (by the manufacturer), and then increased by FDA to age 17 years? Upon what cognitive/decision-making abilities (or other) human FEMALE developmental empirical evidence were either age chosen based? In case you folks didn't know, the average age of menarche in the US human female is far, far below age 16 or 17. There are thousands (probably many more) unintended pregnancies annually in US young women aged below 17 years. What about their rights to obtain such an important, life-altering medication? In many states, they have long ago been granted medical decision-making rights to seek reproductive healthcare without parental/guardian consent; apparently there is sufficiant evidence to support that even a 12 year old female has the cognitive skills to avail herself of this type of service. Granted, in most clinics there is healthcare provider oversight of the learning process... I am concerned that a large (and very vulnerable) subpopulation who perhaps really is able to comprehend the risks/benefits of such a critically important treatment option is being summarily denied the opportunity to do so with the FDA's age qualification of 17 years. Then again, I can certainly foresee all the products liability, med-mal & various other varieties of attorneys just biding their time to file suit with the first "bad" outcome... No easy answers to this one, I know. </1: 1.2.1, 6.5.4>

COMMENT NUMBER - 2005N-0345-EC827

2005N-0345-EC827 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: O'Hagan, James

2005N-0345-EC827 - TEXT

Issue Areas/Comments

Yes it should. FDA rules are much more readily available as meaningful information to typical consumers.

<1: 3.1>Yes it should.</1: 3.1> <2: 3.8.3>FDA rules are much more readily available as meaningful information to typical consumers. </2: 3.8.3>

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

<3: 4.1>Information regarding this interpretation is not well understood by the general public today. </3: 4.1>

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

<4: 5.1, 5.3.1>A rule making on thi sissue helps significantly because of the clear, concise language which typically accomponies such rulemaking on the FDA site. While other information is also available on the site, a rulemaking is a more formal, dated document which is often used as a starting point by other stakeholders in creating their own communications. </4: 5.1, 5.3.1>

<5: 1.2.3, 7.5.3>I am not qualified to answer that question, but I do know, firsthand, that there is already active lawbreaking and misrepresentation going on in society with respect to this medicine and that removing it from prescription for even a small subset of the population will have the practical impact of removing it from prescription for everyone. </5: 1.2.3, 7.5.3>

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

<6: 7.2>Clearly not.</6: 7.2> <7: 7.5.3>Look at methamphetamines and alcohol as examples! </7: 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?

<8: 7.4.3, 8.5.3>It would be far preferable to have different National drug codes: then pharmacies could program POS systems and pharmacy automation systems to help police the use. </8: 7.4.3, 8.5.3>

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

<9: 8.6, 8.6.3, 8.6.4>Why do you want to encourage someone with a prescription, likely subsidized by an insurance plan, to begin sharing their medicine with someone else? If it is legal for this drug, how will you communicate that it is illegal for other drugs? </9: 8.6, 8.6.3, 8.6.4>

COMMENT NUMBER - 2005N-0345-EC83

2005N-0345-EC83 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Smith, Rodney

2005N-0345-EC83 - TEXT

Issue Areas/Comments

<1: 3.2, 3.3.2>No. How can a drug be both, especially when the Rx form is of a HIGHER concentration?</1: 3.2, 3.3.2>

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

<2: 4.2>No.</2: 4.2>

<3: 6.1>Yes.</3: 6.1>

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

<4: 7.2>No.</4: 7.2>

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: 8.2>No.</5: 8.2>

GENERAL

<6: 1.2.3>How can a drug be both OTC and Rx, especially when the proposed OTC dosage is higher than the Rx dosage?

This drug should not be available to minors. That is reason enough to keep it as an Rx.

What about the pharmacists who might refuse to dispense it? </6: 1.2.3>

COMMENT NUMBER - 2005N-0345-EC839

2005N-0345-EC839 - STRUCTURED DATA ELEMENTS

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

2005N-0345-EC839 - TEXT

Issue Areas/Comments

<1: 3.2, 3.8.4>As been the process for a long time, the FDA has a statute that an active ingredient may not be simultaneously marketed in both prescription and OTC drug product. This should stand as is, and not be modified just for this one product. FDA makes these regulations for sound reason and should not be overturned just because a case arises with political interests. I am a pharmacist and what I do is guided by, and I rely on, these statutes. The FDS should stick by its regulations, which have worked so well over time.</1: 3.2, 3.8.4><2: 3.8.8> It would be confusing to have a drug both marketed as prescriptions only and over the counter, especially when there is no difference in the drug or packaging. </2: 3.8.8>

<3: 3.2, 3.8.4>Again, a single active ingredient should not be marketed both as prescription only and over the counter. FDA should stick by their policy which has been in place for many years, without prior incident. They should not make an exception or worse, initiate rulemaking to change this. </3: 3.2, 3.8.4>

<4: 6.2>No.</4: 6.2><5: 7.5.2> there would have to be extensive regulations as to its access. many pharmacists are crunched for time as is. see below. </5: 7.5.2>

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

<6: 7.5.3>It might prove difficult to determine who is eligible to receive the OTC item versus the Rx item-ie, how can we be sure that the person intending consumption falls over the age of 16 or 17?</6: 7.5.3> <7: 7.4.1>In this case, pharmacists would have to control the sale, maybe including the OTC product behing the counter although still OTC. </7: 7.4.1><8: 7.4.4, 7.5.3>We would have to ask for identification, which may prove difficult if the person does not have a drivers license yet (age 16 or 17 may not have one yet).</8: 7.4.4, 7.5.3> <9: 1.2.3, 6.5.3, 7.6>Another issue is that many pharmacist currently have the option NOT to dispense emergency contraception (the case in Maryland),due to relgious beliefs. These pharmacist would also carry this into the process of selling the item OTC. Pharmacists who currently object to dispensing the prescription Plan B would also object to dispensing this item OTC. Taking away that right to object by allowing OTC sale would forfeit the current right to object which has been ruled on, and allowed as long as the Rph refers the patient to another pharmacy who is willing to fill the prescription. Personally, as an Rph with CVS practicing in MD, I was given the opportunity to object to dispensing/filling prescription Plan B, which I enthusiastically took. Allowing this product to go OTC would obliverate this right of mine to refuse to dispense, since I object to its use in those over the age of 17 as well. </9: 1.2.3, 6.5.3, 7.6>

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?

<10: 8.2>no.</10: 8.2>

GENERAL

<11: 1.2.3>Allowing this product to be available OTC, even to a limited population (ie, those over age 17) would be horrific. Having this product OTC would promote unsafe sexual activity overall, increasing the cases of sexually transmitted diseases. When a child/adolescent knows that there is a quick, easy and widely available way to "repair" their situation, they will not take the precautions that they will wihtout this method being so widely available. There is already significant morbidity and mortality associated with STDs. We as a nation are fighting hard and spending billions of dollars on a cure for AIDS, and this move from Rx to OTC will only make the AIDS epidemic worse. When there are no reprocusions for actions, they will engage in these actions-when a patient knows there is a product over the counter to prevent pregnancy right after she engages in unprotected sex, she will. Having this product avaialble OTC will only increase unsafe behavior, and decrease personal responsibility for ones actions (unsafe sex). Yes, studies that have shown evidence to the contrary, but they have been short term in nature, with only a few months to a year in follow up and not powered sufficently. People will see they do not have to take the full responsibility for their actions, and will be less careful with sex knowing there is a security blanket. This means those who use the product will use it repeatedly, which is not its inteded use. Over time having this product available OTC will inevitably lead to increased (unlabeled) use, misconduct and unsafe sexual practices increasing sexually transmitted disease and morbity and mortality. </11: 1.2.3>

COMMENT NUMBER - 2005N-0345-EC85

2005N-0345-EC85 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Oyola, Sandra

2005N-0345-EC85 - TEXT

Issue Areas/Comments

<1: 3.1, 3.8.1>Yes. This would clarify the regulations for any future products that may be sold either as prescription or OTC.</1: 3.1, 3.8.1>

Yes, same comment as above.

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

<2: 4.2>I do not feel there is.</2: 4.2>

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

<3: 5.3.2>Yes, because consumers and manufacturers will have a better understanding of the regulations.</3: 5.3.2>

<4: 6.2>I do not believe so. I do not agree with limiting sales to a subpopulation.</4: 6.2>

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: 8.6, 8.7>This could be very confusing to consumers and even health professionals. For example, Zantac OTC is clearly marked as being OTC, yet it has the same ingredient as the presciption product. This information is included on the packaging. It could also affect insurance coverage/reimbursement.</5: 8.6, 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?

<6: 8.9>Persons of other countries who buy the product here in the U.S. It may be illegal in their country to obtain the medication without a prescription, or, the regulations of their country may require separate and distinct packaging.</6: 8.9>

GENERAL

<7: 1.2.2>I certainly hope the FDA does not succumb to the will of the religious right in this country. If a product is deemed safe, and can help people, it should be allowed to be sold to a consumer. Moral beliefs should not be the deciding factor whether or not medications can be sold over the counter. Perhaps in the near future, pharmacists can privately counsel patients on the proper use of Plan B when a purchase is made. Although Plan B is not a substitute for birth control, it can help reduce the number of unwanted pregnancies in this country, and help women retain their reproductive rights. </7: 1.2.2>

COMMENT NUMBER - 2005N-0345-EC860

2005N-0345-EC860 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Oberst, Sara

2005N-0345-EC860 - TEXT

Issue Areas/Comments

<1: 6.1>Yes, the FDA should be able to sanction pharmacists or pharmacies that are not in compliance.</1: 6.1>

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

<2: 7.1, 7.4.3, 7.4.5>It should be able to take complaints and/or perform random visits to pharmacies. Any found to be acting illegally should be warned with an ultimate penalty of a fine and/or suspension of license.</2: 7.1, 7.4.3, 7.4.5>

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?

<3: 8.1, 8.3.1, 8.3.4>Yes, as long as the appropriate warning is on the outside of the package.</3: 8.1, 8.3.1, 8.3.4>

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

<4: 9.1.1>If the drug caused a severe reaction in one subgroup of the population. By severe I mean death or permanent damage to one's health.</4: 9.1.1>

GENERAL

<5: 1.2.1>Everyone agrees that unplanned pregnancy is a problem in this country. This includes teens, women who've been raped and those whose contraceptive methods fail. As a matter of public health, it is imperative that women have the ability to easily access emergency contraception. By providing this option the number of abortions performed in the US, which has remained steady at about 1.5 million for 15+ years, would decrease; there would be less women and children living in poverty; and rape victims would more easily recover from their assaults. In the case of EC the FDA MUST listen to the scientific evidence. Any other decision would greatly diminish the integrity of the association. </5: 1.2.1>

<6: 1.2.1, 6.6.3>Although I believe that all subgroups should have access to OTC EC, any improvement over the status quo would be welcomed. Perhaps few prescription drugs are treated in this manner, but there are many other examples of assigning age restrictions on substances. Of course with tobacco, for instance, some adolescents under the age of 18 will end up purchasing a pack of cigarettes, but this is a small minority. And because no woman truly wants to use EC it is unlikely that any age restrictions would be broken.</6: 1.2.1, 6.6.3>

COMMENT NUMBER - 2005N-0345-EC870

2005N-0345-EC870 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Vander Bleek, Luke

2005N-0345-EC870 - TEXT

Issue Areas/Comments

<1: 3.2>NO</1: 3.2>

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

<2: 4.2>No</2: 4.2>

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

<3: 5.2>NO</3: 5.2>

<4: 7.3.1.1>If FDA were able to allow these products for sale only in establishments already under FDA jurisdiction e.g. pharmacies, medical clinics, enforcement would seem plausible. However, if FDA allowed the marketing of this class of products by retailers not currently bound by FDA regulation, e.g. mass marketers, enforcement would be tenuous.</4: 7.3.1.1>

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

<5: 7.3.2>Practicality would be dependent on the structure of the business entity allowed to offer these items for sale.</5: 7.3.2>

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: 3.8.8, 8.6.4>A prescription product would assume the patient has had the benefit of a medical examination and consultation of a willing physician and pharmacist.

An OTC product which could be acquired in a self service environment would necessarily carry the responsibility to inform the patient of proper use, mechanism of action, and the dangers of not submitting themselves to routine medical examinations to detect diseases. In the case of emergency contraceptive marketing, and despite the most comprehensive labeling, I believe that many young sexually active women will not recognize the value of routine gynecologic exams. These women will likely never submit themselves to routine gynecologic exams and public health will suffer.</6: 3.8.8, 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: 9.2.1>Two products could be packaged in a single package techniqe, only when a substantial review of the impact of marketing the product over the counter would reveal that all other public health issues would either improve of remain unchanged.</7: 9.2.1>

GENERAL

<8: 1.2.3>Over the counter status of any drug should require research to assure that public health will be improved or at a minimum, not jeopardized by the OTC status. In my experience as a community pharmacist, many women submit themselves to a gynecologic exam only when necessary to receive a contraceptive prescription. Since many diseases and other health conditions are discovered and consequently treated pursuant to routine exams, I believe public health will suffer from the otc status of emergency contraceptives, regardless of age requirements. </8: 1.2.3>

COMMENT NUMBER - 2005N-0345-EC882

2005N-0345-EC882 - STRUCTURED DATA ELEMENTS

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

2005N-0345-EC882 - TEXT

GENERAL

See attachment

2005N-0345-EC882-Attach-1.DOC

ATTACHMENT:

To whom it may concern:
<1: 1.2.3>I am a concerned citizen. Allow me to preface my comments with the following information from the web site of Barr Labs, the manufacturer of Plan B(R).
www.go2planb.com/ForConsumers/AboutPlanB/HowItWorks.aspx

"Plan B(R) is approved by the FDA and contains the hormone levonorgestrel, the same hormone in the birth control pills that healthcare professionals have been prescribing for more than 35 years. The difference is that Plan B(R) contains a larger dose of levonorgestrel than the amount found in a single birth control pill."

As are you, I am certain that this is an over-simplification of the issue. I ask you, would Barr Labs tell prospective customers that an anticoagulant, Warfarin, which they also happen to sell, is safe because it is only rat poison-the only difference being the dosage level? Certainly not, but Barr leaves this bit of information out of its Warfarin literature. I infer that it would be too dangerous to Barr Labs for its consumers and prospective consumers to realize one important thing about pharmacology: that the effects of a drug therapy are often as dependent on the dosage level of a drug as they are on the drug itself.

In the above consumer information, Barr states that Plan B(R) simply "…contains a larger dose of levonorgestrel than the amount found in a single birth control pill." In my opinion, Barr Labs and its marketing team are attempting to capitalize on the public's lack of awareness of the importance of dosage.

In fact, the action of the drug is very much different from a "birth control pill." Note Barr's clever use of information from its web site:

Plan B(R) works like a regular birth control pill. It prevents pregnancy mainly by stopping the release of an egg from the ovary, and may also prevent the fertilization of an egg (the uniting of sperm with the egg). Plan B(R) may also work by preventing it from attaching to the uterus (womb). It is important to know that Plan B(R) will not affect a fertilized egg already attached to the uterus; it will not affect an existing pregnancy.

It is important to note that the antecedent of "it" (highlighted in the third sentence) appears to be "egg." "It," however, refers to a fertilized egg. This information was very cleverly worded by Barr to do nothing but mislead the public. Whether one knows that life begins when a sperm meets an egg, or argues that it begins at some other arbitrary point, it is clear that Plan B(R) does not work "like a regular birth control pill," as stated by its manufacturer. </1: 1.2.3>

<2: 3.8.8>It is a certainty that the general public's understanding of the intricacies of how drugs act on the body varies a great deal-from very little to expert. Not many of us have had advanced training in the study of pharmacology or have a working knowledge of advanced chemistry. For this reason, I believe that the average prospective consumer of this drug is vulnerable to this company's aforementioned sales propaganda. I am certain that OTC approval of Plan B(R) would be tantamount to unleashing Barr Labs and its "misinformation sales machine" on an unaware public.

At this time, the public is safeguarded by the knowledge, training and consultation of its doctors and pharmacists. If Plan B(R) were to reach the OTC shelves, these safeguards will have been sacrificed-in my opinion a risk to public health. </2: 3.8.8>

<3: 1.2.3>Please continue to take Barr Labs and their comments about Plan B(R) with the proverbial "grain of salt." As you can see in the literature they present to the public, Barr is not above sacrificing important information about their product as a means to an end: expanded sales of a product that is very much different from traditional contraceptives. Based on Barr's current conduct, there is no indication that FDA approval of Plan B(R) for OTC sales will spur their corporate philosophy-and consequently the information they offer consumers-to change. In such a case, I predict an even more blatant campaign of misinformation.

Being men and women of Science-and being charged with the awesome responsibility to safeguard public health-it is incumbent upon you at the FDA to weigh the risks of this drug's effects on the general public. I am certain that an OTC version of Plan B(R) will tout itself-as has its prescription counterpart-as a"regular birth control pill." This false information is a risk that our public simply cannot afford.

Based on these concerns, I urge the FDA to deny Plan B entry into the OTC market.</3: 1.2.3>

Respectfully,

Peter M. Vander Bleek

rule

COMMENT NUMBER - 2005N-0345-EC895

2005N-0345-EC895 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Holden, Karen

2005N-0345-EC895 - TEXT

Issue Areas/Comments

<1: 3.1, 3.8.3>If a there is evidence that a prescription drug poses a particular risk to a particular subgroup of the population, then the FDA may impose added restrictions for that group, including marketing the drug simultaneously as OTC and prescription. However, the definition of risk should encompass only safety or efficacy of the particular medication, and should be based on accepted evidence. Any other basis or concern used to deny access to medication to a partcular subgroup is beyond the legitimate interest of the FDA.</1: 3.1, 3.8.3>

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

<2: 4.3.4>The confusion arises from FDA's seeming to ignore the advise of its professional staff and instead to bow to political pressures from the religious right.</2: 4.3.4>

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

<3: 5.5>Only if the rulemaking were based on legitimate concerns about the SAFETY and EFFICACY of a particular medication in a particular subgroup. Rulemakings done for the sole purpose of social engineering at the behest of religious concerns is insidious and likely unconstitutional. It would increase confusion over the role of the FDA, and lead to lawsuits.</3: 5.5>

COMMENT NUMBER - 2005N-0345-EC896

2005N-0345-EC896 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Guy, Katie

2005N-0345-EC896 - TEXT

Issue Areas/Comments

<1: 7.5.3>If a drug has a limitation for one group of individuals and not another, being simutaneously sold as a prescription and an OTC drug will open the door for those individuals the FDA has put the limit on to easily obtain the drug illegally through a relative or friend and putting them in danger. I strongly oppose this action.</1: 7.5.3>

<2: 7.5.3>This would be extremely hard to enforce by law. Any GIRL 16 years or younger can easily have a friend or relative purchase the drugh OTC for them. If, as a result of this act, the child fell ill the FDA would be responsible.</2: 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?

<3: 8.5.4>This action would add even further confusion to the scenario. Having them sold in the same package would make it virtually impossible to determine if the minor child had obtained the drug lawfully, through a prescription.</3: 8.5.4>

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

<4: 9.1.1>In the circumstance of the