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Commenter Organization Name: GlaxoSmithKline
Comment Number: 2005N-0345-C307
Excerpt Number: 8
Excerpt Status: NEW
Other Sections: NEW - 6.3.1 - FD&C Act
NEW - 7.1 - Yes
Excerpt Text:
Thus, this is a situation where FDA, in their capacity as:
". . . experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, . . . for use under the conditions prescribed, recommended, or suggested in the labeling.. ." (FFDCA, section 201(p)),
have the authority to determine the approvability of a drug product as described by a Sponsor. As a practical matter, in our experience, it is enforceable.
Commenter Organization Name: White, Molly
Comment Number: 2005N-0345-EC107
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 6.3.5 - Other legal/policy arguments
Excerpt Text:
Why not? Other agencies do. Examples: Only people who have completed medical school are permitted to practice medicine. Only people of a certain age are permitted to vote or drive. Only people born in the US can be president. Just because the FDA has not tried it to date doesn't make it a particularly original or difficult problem.
Commenter Organization Name: McCormick, Michelle
Comment Number: 2005N-0345-EC1086
Excerpt Number: 4
Excerpt Status: NEW
Other Sections: NEW - 6.6.1 - State and local agencies have authority to enforce point-of-sale (e.g., recent limitations on cold medicines)
Excerpt Text:
Sure. In California, the sale of over the counter sinus medication (used in the production of methanphetimines) is restricted to people with an ID stating that they are over 18 years of age. This seems to be working.
Commenter Organization Name: Burometto Jr, Charles
Comment Number: 2005N-0345-EC109
Excerpt Number: 5
Excerpt Status: NEW
Other Sections: NEW - 3.8.2 - Two-class system (OTC and Rx) not sufficient - need a third class of "behind-the-counter" drugs (pharmacist distributed)
Excerpt Text:
Yes, by creating a third class of drugs for sale by a pharmacist. By restricting the sale of a drug by a pharmacist without a prescription, the pharmacist would br held accountable to enforce the limitation on the sale of the product.
Commenter Organization Name: Chihane, Ziad
Comment Number: 2005N-0345-EC13197
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 7.3.1.1 - Require sales restrictions as condition for approval (e.g., restrict sales to entities that are licensed pharmacies)
Excerpt Text:
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.
Commenter Organization Name: Nguyen, Marie
Comment Number: 2005N-0345-EC13851
Excerpt Number: 6
Excerpt Status: NEW
Excerpt Text:
The FDA would be able to enforce the limitation as a matter of law to the sale of OTC product to a subpopulation.
Commenter Organization Name: Lamotte, Diane
Comment Number: 2005N-0345-EC155
Excerpt Number: 5
Excerpt Status: NEW
Excerpt Text:
I believe that the FDA can enforce whatever it wants or needs to.
Commenter Organization Name: Yao, Yvonne
Comment Number: 2005N-0345-EC1565
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 6.6.3 - Alcohol and tobacco enforcement
Excerpt Text:
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.
Commenter Organization Name: Bachelor, Emiliann
Comment Number: 2005N-0345-EC160
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes.
Commenter Organization Name: Hutson, Paul
Comment Number: 2005N-0345-EC162
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 7.3.1.1 - Require sales restrictions as condition for approval (e.g., restrict sales to entities that are licensed pharmacies)
Excerpt Text:
Yes, if the non-prescription sale was made through a licensed pharmacy and by a licensed pharmacist, PA, or NP.
Commenter Organization Name: Reusch, Elizabeth
Comment Number: 2005N-0345-EC165
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 6.6.3 - Alcohol and tobacco enforcement
Excerpt Text:
Yes, limitation of products by age are common in the United States for the sale of lottery tickets, alcohol, cigarettes, even movie tickets by requiring the presentation of a legal identification. A movie rated R is restricted from teenagers buying the product; A lottery ticket is restricted to those over the age of 21 (Arizona law); cigarettes are restricted to those over 18; alcohol is restricted to those over 21. Age restrictions are used throughout this nation to limit exposure to products.
Commenter Organization Name: American Pharmacists Association
Comment Number: 2005N-0345-EC16675
Excerpt Number: 10
Excerpt Status: NEW
Excerpt Text:
Yes, as a matter of law, the FDA can enforce a subpopulation limitation on the sale of an OTC product.
Commenter Organization Name: Ross, Angela
Comment Number: 2005N-0345-EC172
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 6.6.3 - Alcohol and tobacco enforcement
NEW - 7.4.4 - Require identification for age
Excerpt Text:
Absolutely. In the same way that alcohol and tobacco are perfectly legal to one population (those over the age of 21 and 18, respectively) and enforceably illegal to a subpopulation (those underage), it would be enforceable to limit sales of an FDA-approved product. It would absolutely not be enforceable to limit sales to a subpopulation based on almost anything other than age, however, as age is easily determined by simple identification.
Commenter Organization Name: Murphy, Cynthia
Comment Number: 2005N-0345-EC176
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
Yes, but why would it want to.
Commenter Organization Name: Murphy, Cynthia
Comment Number: 2005N-0345-EC176
Excerpt Number: 5
Excerpt Status: NEW
Other Sections: NEW - 6.3.5 - Other legal/policy arguments
NEW - 6.6.3 - Alcohol and tobacco enforcement
Excerpt Text:
Yes, this should be obvious as there are several products sold at market that the sales of which are restricted only by age. (alcohol, cigarettes, alieve-neproxin)
Commenter Organization Name: Steward, Linda
Comment Number: 2005N-0345-EC181
Excerpt Number: 5
Excerpt Status: NEW
Other Sections: NEW - 6.3.5 - Other legal/policy arguments
Excerpt Text:
yes. Laws would be made to make sure of that.
Commenter Organization Name: Gibbons, Bridget
Comment Number: 2005N-0345-EC2009
Excerpt Number: 8
Excerpt Status: NEW
Excerpt Text:
Absolutely.
Commenter Organization Name: Levy, Gayle
Comment Number: 2005N-0345-EC206
Excerpt Number: 5
Excerpt Status: NEW
Excerpt Text:
Yes.
Commenter Organization Name: Oyen, Duane
Comment Number: 2005N-0345-EC2107
Excerpt Number: 4
Excerpt Status: NEW
Other Sections: NEW - 6.6.3 - Alcohol and tobacco enforcement
Excerpt Text:
Society does it all the time with substances that are legal but limited to adults- cigarettes and alcohol, for example; prescription items are easier to track than those products.
Commenter Organization Name: Ellis, Pamela
Comment Number: 2005N-0345-EC216
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
Yes
Commenter Organization Name: Dietz, Ken
Comment Number: 2005N-0345-EC217
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 6.6.3 - Alcohol and tobacco enforcement
NEW - 6.6.4 - Other entities
Excerpt Text:
The government currently has regulations in place requiring age-limited availability for cigarettes, alcohol, firearms, pornography, and lotto tickets. But you can't establish a similar regulation for Plan B?
Commenter Organization Name: Cepeda, Baudi
Comment Number: 2005N-0345-EC226
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
YES
Commenter Organization Name: National Research Center for Women
Comment Number: 2005N-0345-EC2314
Excerpt Number: 7
Excerpt Status: NEW
Excerpt Text:
The FDA has the legal authority to restrict an OTC product in this manner
Commenter Organization Name: National Research Center for Women
Comment Number: 2005N-0345-EC2314
Excerpt Number: 9
Excerpt Status: NEW
Other Sections: NEW - 6.3.1 - FD&C Act
NEW - 6.4.1 - Nicotine replacement therapy (e.g., Nicorette)
Excerpt Text:
The Office of Chief Counsel has previously determined that age restrictions for an OTC product are legal, as in the case of Nicorette nicotine replacement therapy. Furthermore, there is no indication that counsel was concerned that such a restriction would be unenforceable. A document regarding the approval of Nicorette for OTC status states:
Furthermore, the OGC has provided us with a legal opinion that it is possible under the FC&C act to impose restriction on the sale of the product to minors, if such restrictions are needed to ensure their safety.
The FDA?s decision that it has the authority to restrict the sale of OTC products to minors in the case of Nicorette applies with equal and full force to Plan B. While we disagree with the FDA?s view that Plan B has not been proven safe for the restricted age cohort, FDA has, on advice of its own counsel, made exactly the same kind of age distinction for Nicorette as it can make for Plan B in approving the drug for OTC use.
Commenter Organization Name: Salvo, Aaron
Comment Number: 2005N-0345-EC24
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 6.6.3 - Alcohol and tobacco enforcement
Excerpt Text:
The FDA has enforced the sale of certains drugs without the assistance of a perscription. Once again alcholic beverages and cigarettes come to mind. A perscription is not needed for either product, yet the FDA limited access to these products by people below a specific age. Even though drinking ages are regulated by the states, there is at least precedence in law to keep a product out of the hands of a certain sub-population.
Commenter Organization Name: Cunningham, Wayne
Comment Number: 2005N-0345-EC240
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
Yes. Other items have been regulated in a similar fashion.
Commenter Organization Name: Endris, Kelle
Comment Number: 2005N-0345-EC278
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
Possibly.
Commenter Organization Name: TomHon, Catherine
Comment Number: 2005N-0345-EC281
Excerpt Number: 5
Excerpt Status: NEW
Other Sections: NEW - 6.3.5 - Other legal/policy arguments
Excerpt Text:
Yes, it should be able to legally enforce the limitation. The FDA should also be able to act against off-label drug use. But whether the FDA does undertake enforcement is another question. To make this the deciding factor for approval means that the FDA should hold its legal ability to enforce, as a standard to be met by all drugs up for approval. Given the rise in the number of prescriptions dispensed for conditions for which the drug was never approved, this would swamp the FDA with enforcement issues.
Commenter Organization Name: Wu, Jackie
Comment Number: 2005N-0345-EC307
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
Yes.
Commenter Organization Name: Deneris, Angela
Comment Number: 2005N-0345-EC365
Excerpt Number: 5
Excerpt Status: NEW
Other Sections: NEW - 6.6.3 - Alcohol and tobacco enforcement
Excerpt Text:
YES! We do now with tobacco and alcohol. I see no reason that a pharmacist couldn't ask for ID. They do so now with Schedule I and II medications.
Commenter Organization Name: Schulman, Marvin
Comment Number: 2005N-0345-EC418
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
Yes.
Commenter Organization Name: Duchon, Kathleen
Comment Number: 2005N-0345-EC426
Excerpt Number: 4
Excerpt Status: NEW
Other Sections: NEW - 6.6.1 - State and local agencies have authority to enforce point-of-sale (e.g., recent limitations on cold medicines)
Excerpt Text:
Why not? They have enacted other new procedures such as ID for antihistamines. Why could the same implementation be put into affect for other drugs?
Commenter Organization Name: Lamermayer, Richard J
Comment Number: 2005N-0345-EC43
Excerpt Number: 6
Excerpt Status: NEW
Excerpt Text:
Legally, FDA would probably be able to enforce such a limitation.
Commenter Organization Name: Clason, Dennis
Comment Number: 2005N-0345-EC47
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 6.6.3 - Alcohol and tobacco enforcement
Excerpt Text:
It seems rather clear that both State and Federal bodies regulate and enforce product restrictions to particular subpopulations. The legal age for alcohol consumption is 21 years in all 50 states, and this age limit is enforced by both the various States and by Federal agencies (e.g., Department of Defense). Many States have laws and regulations which control the distribution of tobacco products to those over an age limit, and they are able to enforce their laws and regulations. Other substances controlled in similar ways include inhalants (toluene-containing glues and aerosols) and spray paints.
Clearly, if it is permissible for State and Federal agencies to restrict distribution of certain compounds by age, it is both permissible and possible for the FDA to do so.
Commenter Organization Name: Katrib, Elise
Comment Number: 2005N-0345-EC516
Excerpt Number: 5
Excerpt Status: NEW
Excerpt Text:
Yes it is possible to sell to a subpopulation.
Commenter Organization Name: Zahn, Steven
Comment Number: 2005N-0345-EC52
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
Yes.
Commenter Organization Name: Rectenwald, Theodore
Comment Number: 2005N-0345-EC535
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
Yes.
Commenter Organization Name: Venturella, Vincent
Comment Number: 2005N-0345-EC58
Excerpt Number: 4
Excerpt Status: NEW
Other Sections: NEW - 6.3.2 - No laws prevent the policy
Excerpt Text:
I do not see any deviation from the law(s) available to the FDA under the current FD&C Act that would prevent it from instituting this policy.
Commenter Organization Name: Goodman, Evan
Comment Number: 2005N-0345-EC6
Excerpt Number: 5
Excerpt Status: NEW
Other Sections: NEW - 6.6.3 - Alcohol and tobacco enforcement
Excerpt Text:
Regulations based on age have existed in this country since it's onset. Voting was the first restriction, tobacco and alcohol have legal ages for purchase at stores across the country.
Commenter Organization Name: Card, Alan
Comment Number: 2005N-0345-EC61
Excerpt Number: 6
Excerpt Status: NEW
Other Sections: NEW - 6.6.3 - Alcohol and tobacco enforcement
Excerpt Text:
Of course this plan would be enforceable under law, just as age restrictions on the purchase of tobacco and alcohol are enforceable under law. The legal powers of the FDA are more than broad enough to allow for this.
Commenter Organization Name: Baird, Debora
Comment Number: 2005N-0345-EC66
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
Yes
Commenter Organization Name: Carter, Thomas
Comment Number: 2005N-0345-EC691
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
Yes, I believe so.
Commenter Organization Name: Dawson, Jennifer
Comment Number: 2005N-0345-EC7
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes, the limitation would be easily enforceable.
Commenter Organization Name: Rosati, Lucia
Comment Number: 2005N-0345-EC76
Excerpt Number: 8
Excerpt Status: NEW
Excerpt Text:
The FDA through the pharmacy chains would be able to enforce it just as they enforce any other prescription medication.
Commenter Organization Name: Carlson, Brent
Comment Number: 2005N-0345-EC77
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
Yes.
Commenter Organization Name: Phlips, Thomas
Comment Number: 2005N-0345-EC788
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
Probably.
Commenter Organization Name: Smith, Rodney
Comment Number: 2005N-0345-EC83
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
Yes.
Commenter Organization Name: Oberst, Sara
Comment Number: 2005N-0345-EC860
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes, the FDA should be able to sanction pharmacists or pharmacies that are not in compliance.
Commenter Organization Name: Townsend, Elisha
Comment Number: 2005N-0345-EC90
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
They could, but they should not.
Commenter Organization Name: Mock, Suzanne
Comment Number: 2005N-0345-EC940
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
I believe this could occur.
Commenter Organization Name: Brass, Kathryn
Comment Number: 2005N-0345-EC951
Excerpt Number: 9
Excerpt Status: NEW
Other Sections: NEW - 6.6.3 - Alcohol and tobacco enforcement
Excerpt Text:
As mentioned above, such limitations on alcohol and tobacco are widespread and enforceable.
Commenter Organization Name: Brakman, Anita
Comment Number: 2005N-0345-EC97
Excerpt Number: 5
Excerpt Status: NEW
Excerpt Text:
Yes.
Commenter Organization Name: Syed, Misbah
Comment Number: 2005N-0345-EMC368
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
If the FDA did limit the sale of an over-the-counter product to a particular population by making the product available to the people in prescription form only, the FDA would be able to enforce such a limitation because they can set standards to a targeted population. For instance, Plan B can be over-the-counter to women 17 and older, but prescription for women younger than 17. The practitioners can also take into consideration with the consent of parents of women younger than 17, if they should be allowed to use such product, even if some argue that it will make teenagers think that sex is appropriate.
Commenter Organization Name: Thames, Samuel
Comment Number: 2005N-0345-EMC374
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
NEW - 4.1 - Yes
NEW - 8.1 - Yes
Excerpt Text:
In regards to the FDA?s request for comments on the advance notice of proposed rulemaking for the simultaneous marketing of drugs with identical active ingredients as both over the counter and prescription, I believe that the FDA should proceed with rulemaking to codify its interpretation of section 503 (b), that there is significant confusion in its current state, and that rulemaking would help dispel the confusion that is caused by the current rule. I also believe that the FDA would be able to legally enforce limitations on certain subpopulations and that those limitations could be practically enforced. Finally I believe that it would be legal to sell the products in the same packaging but that there would be some circumstances where selling identical items would be inappropriate.
Commenter Organization Name: Thames, Samuel
Comment Number: 2005N-0345-EMC374
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 6.3.5 - Other legal/policy arguments
NEW - 7.1 - Yes
Excerpt Text:
If the FDA during the process of rulemaking was to place restrictions on certain subpopulations in regards to this rule, not only could it be legal but also vital to the rule affecting significant change. I will assume that the main subpopulation targeted by the restrictions would be those below a certain age. In this case, legally enforcing the rule will not only be legal, it will be practical as well. There are currently age restrictions of all kinds that spread across a broad range of products. These restrictions are enforced every day in a legal and practical manner. Putting similar restrictions on the over the counter sell to a subpopulation below a certain age should not produce many legal or practical problems and should also affect many of the same results that current restrictions do. Legal and practical problems aside, putting restrictions on a certain age subpopulation would produce some highly desirable effects. First off it would prevent irresponsible youths from acquiring drugs that they are either too young to fully grasp the implications of or that support behaviors that are not desirable. In putting an age restriction on over the counter sales of certain drugs and requiring a prescription for this subpopulation to acquire the drug, it would allow a more responsible adult in on the decision. A doctor could more fully explain the consequences and uses of a drug than an underage consumer could learn from reading the side of a drug box. The effects of a drug alone are not the only concerns when dealing with the availability of drugs to underage consumers. There are damaging behaviors that a lack of an age restriction would help breed. In the case of the ?morning after pill,? the ability to get the drug over the counter would leave the potentially detrimental side effects of the behavior that led up to the pill?s need unexplained. By going to a doctor to get a prescription for the pill, there would be an opportunity for the potentially damaging effects their behavior could have to be explained by a responsible and trained professional. At the very least, an age restriction on certain drugs would allow for an older, and hopefully more responsible, person in on the process.
Commenter Organization Name: Alterton, Faith
Comment Number: 2005N-0345-C83
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 7.2 - No
Excerpt Text:
NO.
Commenter Organization Name: Rucker, Gwendolyn
Comment Number: 2005N-0345-EC1080
Excerpt Number: 4
Excerpt Status: NEW
Other Sections: NEW - 7.5.3 - Actual compliance will be difficult/impossible/burdensome to achieve
Excerpt Text:
No. You would wind up with the exact same issues we have with alcohol & cigarettes. Adults will purchase and give to underage people. With the issue of the Morning-After-Pill, you would additionally have the issue of Male Sexual Predators using it as an illegal and unknown to the women method of birth control.
Commenter Organization Name: Black, Jerrold
Comment Number: 2005N-0345-EC111
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
no
Commenter Organization Name: Slee, April
Comment Number: 2005N-0345-EC121
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 6.3.4 - Age limitations are in line with other meaningful differences
Excerpt Text:
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.
Commenter Organization Name: Steele, Robert
Comment Number: 2005N-0345-EC146
Excerpt Number: 4
Excerpt Status: NEW
Other Sections: NEW - 6.5.1 - FDA's authority limited to drug safety, effectiveness/efficacy, and labeling
Excerpt Text:
"Enforcement" should not be the FDA's primary responsibilty in these cases - rulemaking is.
Commenter Organization Name: Steele, Robert
Comment Number: 2005N-0345-EC146
Excerpt Number: 6
Excerpt Status: NEW
Other Sections: NEW - 6.5.1 - FDA's authority limited to drug safety, effectiveness/efficacy, and labeling
Excerpt Text:
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.
Commenter Organization Name: Loomis, Shirley
Comment Number: 2005N-0345-EC147
Excerpt Number: 5
Excerpt Status: NEW
Other Sections: NEW - 6.7 - Miscellaneous arguments/discussions
NEW - 7.5.3 - Actual compliance will be difficult/impossible/burdensome to achieve
Excerpt Text:
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.
Commenter Organization Name: Academy of Managed Care Pharmacy
Comment Number: 2005N-0345-EC15687
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.3.2 - FD&C Act is clear regarding when a drug should be prescription only
Excerpt Text:
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.
Commenter Organization Name: Walsh, Melissa
Comment Number: 2005N-0345-EC15931
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 6.5.4 - Other arguments
Excerpt Text:
A. If the FDA limited the sale of an OTC product by making it remain prescription for a subpopulation what would be its reasoning? If a product is made over the counter, and yet is unsafe for certain individuals, the FDA's integrity could be held in question. The FDA could be accused of discrimination against that subpopulation or approving a dangerous drug to please drug companies. Either way the general public would receive mixed messages which may cause them to doubt the trust they put in the FDA.
Commenter Organization Name: Jones, Kim
Comment Number: 2005N-0345-EC16543
Excerpt Number: 4
Excerpt Status: NEW
Other Sections: NEW - 6.5.4 - Other arguments
Excerpt Text:
No. It would implicate equal protection rights, among other problems.
Commenter Organization Name: Hein, Rachel
Comment Number: 2005N-0345-EC168
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
The FDA should not limit the sale of an OTC product to a particular subpopulation.
Commenter Organization Name: Wilson, Rhianna
Comment Number: 2005N-0345-EC186
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 6.5.4 - Other arguments
Excerpt Text:
No, the gaurdians and parents of that subpopulation should be able to purchase the medication for the subpopulation.
Commenter Organization Name: Crousey, Joshua
Comment Number: 2005N-0345-EC1970
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 6.5.4 - Other arguments
Excerpt Text:
No, as a law student I can say that there would be significant limitations. This would be regarded as creating a 'class' of people. This always has problems associated with it.
Commenter Organization Name: Young, Stan
Comment Number: 2005N-0345-EC211
Excerpt Number: 4
Excerpt Status: NEW
Other Sections: NEW - 6.5.3 - Court cases
Excerpt Text:
No, this question has already been addressed in the case of parental notification laws, for example. They linger for a little while, then are tossed out at appeals court level.
Commenter Organization Name: Rankis, A
Comment Number: 2005N-0345-EC22
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
No
Commenter Organization Name: Labbe, Carl
Comment Number: 2005N-0345-EC408
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
Not under current rules.
Commenter Organization Name: Thompson, Donald
Comment Number: 2005N-0345-EC416
Excerpt Number: 4
Excerpt Status: NEW
Other Sections: NEW - 6.7 - Miscellaneous arguments/discussions
Excerpt Text:
No, neither FDA nor state and local authorities would be able to enforce such limitations. Law enforcement and regulatory activities are often low on the priority list for local officials compared to violent crime, so such legal enforcement is very unlikely to occur.
Commenter Organization Name: Landauer, Christopher
Comment Number: 2005N-0345-EC49
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 6.5.1 - FDA's authority limited to drug safety, effectiveness/efficacy, and labeling
NEW - 7.2 - No
NEW - 7.5.2 - Infrastructure for FDA enforcement (e.g., resources, personnel, training, monitoring, third-party regulations) not in place
Excerpt Text:
No, the agency does not have the capacity to enforce a perscription program to any subpopulation. The agencies responsibility is to ensure that only safe, ethical drugs are allowed in the marketplace. The agency does not have the ability to enforce age limitations with respect to perscription drugs. Hence this drug product should only be perscribed by a medical professional.
Commenter Organization Name: Padden, Phillip
Comment Number: 2005N-0345-EC505
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 6.5.4 - Other arguments
Excerpt Text:
No, but as a matter of law all America's should have equal access to drugs without any government restrictions/prohabitions. The constitutions allows for the regulation of interstate trade, not the restriction of it.
Commenter Organization Name: Zahn, Steven
Comment Number: 2005N-0345-EC52
Excerpt Number: 5
Excerpt Status: NEW
Excerpt Text:
No, not under the current regulations and its interpretations.
Commenter Organization Name: Thompson, Sharon
Comment Number: 2005N-0345-EC526
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 7.5.3 - Actual compliance will be difficult/impossible/burdensome to achieve
Excerpt Text:
It would not be possible to regulate having "prescription" status for a particular subpopulation because it would be too easy to circumvent this.
Commenter Organization Name: Ramirez, Robert
Comment Number: 2005N-0345-EC527
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
No. One this would be a enforcement nightmare.
Commenter Organization Name: Rommel, Scott
Comment Number: 2005N-0345-EC54
Excerpt Number: 4
Excerpt Status: NEW
Other Sections: NEW - 3.8.7 - Cost-benefit concerns regarding rulemaking
Excerpt Text:
NO, This seems to be a problem waiting for a whole lot of money to be waisted on. Either a drug is over the counter or it is not.
Commenter Organization Name: Della Paolera, Mark
Comment Number: 2005N-0345-EC555
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
NO, the FDA cannot guarantee that such age restrictions would be satisfied.
Commenter Organization Name: Porter, Rebecca
Comment Number: 2005N-0345-EC56
Excerpt Number: 5
Excerpt Status: NEW
Excerpt Text:
No.
Commenter Organization Name: Burgess, Annette
Comment Number: 2005N-0345-EC566
Excerpt Number: 6
Excerpt Status: NEW
Excerpt Text:
No.
Commenter Organization Name: Tansley, Kathleen
Comment Number: 2005N-0345-EC569
Excerpt Number: 7
Excerpt Status: NEW
Other Sections: NEW - 6.5.4 - Other arguments
NEW - 7.5.3 - Actual compliance will be difficult/impossible/burdensome to achieve
Excerpt Text:
Selective limitation of a product to a sub-population could bring on lawsuits from either end of the spectrum from disgruntled consumers, as well as media controversy on the issue, and a near insurmountable impossibilty to enforce such a regulation.
This is a bad idea for the FDA to pursue.
Commenter Organization Name: Doran, Gregory
Comment Number: 2005N-0345-EC586
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
No.
Commenter Organization Name: Billingsley, Daniel
Comment Number: 2005N-0345-EC609
Excerpt Number: 5
Excerpt Status: NEW
Other Sections: NEW - 6.5.4 - Other arguments
Excerpt Text:
The enforcement would not fall to the FDA, it would fall on the entity selling the product.
Commenter Organization Name: Koch, Frances
Comment Number: 2005N-0345-EC610
Excerpt Number: 8
Excerpt Status: NEW
Other Sections: NEW - 6.6.3 - Alcohol and tobacco enforcement
Excerpt Text:
I do not think that this would be possible. The accessibility of alcohol and cigarettes to minors - despite strict laws on the books - shows that in practice, limitations to subpopulations is not a practical solution.
Commenter Organization Name: Ray, Amy
Comment Number: 2005N-0345-EC65
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
No
Commenter Organization Name: Vrankar, Anna
Comment Number: 2005N-0345-EC668
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
NO
Commenter Organization Name: Friedl, Mary Frances
Comment Number: 2005N-0345-EC671
Excerpt Number: 5
Excerpt Status: NEW
Other Sections: NEW - 7.5.3 - Actual compliance will be difficult/impossible/burdensome to achieve
Excerpt Text:
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.
Commenter Organization Name: Gordon, Jennifer
Comment Number: 2005N-0345-EC677
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
Without any real knowledge of law, I believe that a law must be reasonably enforceable to be real law.
Commenter Organization Name: Socha, Kathleen
Comment Number: 2005N-0345-EC678
Excerpt Number: 6
Excerpt Status: NEW
Other Sections: NEW - 6.6.3 - Alcohol and tobacco enforcement
Excerpt Text:
You can't even prevent kids from buying cigarettes or alcohol. What are you thinking?
Commenter Organization Name: Schulz, Stan
Comment Number: 2005N-0345-EC680
Excerpt Number: 6
Excerpt Status: NEW
Other Sections: NEW - 6.5.4 - Other arguments
Excerpt Text:
Probably not. It would result in lawsuits challenging the right to restrict sales; challenging the appropriateness of the cutoff age, alleging age discrimination.
Commenter Organization Name: Long, Laura Jean
Comment Number: 2005N-0345-EC762
Excerpt Number: 6
Excerpt Status: NEW
Excerpt Text:
No.
Commenter Organization Name: Jago, Laura
Comment Number: 2005N-0345-EC839
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
No.
Commenter Organization Name: Oyola, Sandra
Comment Number: 2005N-0345-EC85
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
I do not believe so. I do not agree with limiting sales to a subpopulation.
Commenter Organization Name: Hawkins, Susan
Comment Number: 2005N-0345-EC91
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 7.5.3 - Actual compliance will be difficult/impossible/burdensome to achieve
Excerpt Text:
I don't see how it's possible. You talk of selling only to women. Yes, women will be the ones taking the drug, but a man may purchase the drug for his partner. You cannot know whether his partner is 17+ or not.
Commenter Organization Name: Aengst, Jennifer
Comment Number: 2005N-0345-EC921
Excerpt Number: 5
Excerpt Status: NEW
Other Sections: NEW - 6.5.4 - Other arguments
Excerpt Text:
No I think that's an inappropriate use of the FDA's power. Targetting a particular subpopulation is discriminatory...either the medicine is available OTC to everyone or it's not. It's questionnable that the FDA would want to determine which population can have access or not. Either it is available or not...education and warnings can certainly be there, recommendations are appreciated, but if something is going to be available OTC, that means that the FDA has to let go of any sort of control of who buys it.
Commenter Organization Name: Wurtz, Richard
Comment Number: 2005N-0345-EC94
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
NO
Commenter Organization Name: GlaxoSmithKline
Comment Number: 2005N-0345-C307
Excerpt Number: 8
Excerpt Status: NEW
Other Sections: NEW - 6.1 - Yes
NEW - 7.1 - Yes
Excerpt Text:
Thus, this is a situation where FDA, in their capacity as:
". . . experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, . . . for use under the conditions prescribed, recommended, or suggested in the labeling.. ." (FFDCA, section 201(p)),
have the authority to determine the approvability of a drug product as described by a Sponsor. As a practical matter, in our experience, it is enforceable.
Commenter Organization Name: American Society for Reproductive Medicine
Comment Number: 2005N-0345-C350
Excerpt Number: 11
Excerpt Status: NEW
Excerpt Text:
1. OTC Levonorgestrel Intended for Use by Women Falling Under the Age Limitation Would be an "Unapproved New Drug"
The FDCA provides a panoply of legal restrictions on the sale of unapproved new drugs. As a matter of law, FDA can restrict the "introduction into interstate commerce" of an unapproved new drug such as OTC Plan B intended for use by a woman under the age of 16.
The statute prohibits the "introduction into interstate commerce [of] any new drug" the approval of which is not in effect under section 505 of the FDCA. 21 USC 355(a); 331 (d). New drugs are approved by the agency after evaluation of the results of clinical investigations designed to demonstrate whether the drug is safe and effective "under the conditions of use prescribed, recommended, or suggested in the proposed labeling." See 21 USC 355(d). Any new "intended use" of the product by the manufacturer beyond the use set forth in the labeling requires "adequate directions for use," which are necessarily lacking without FDA review and approval. See 21 USC 352(f)(1); 21 CFR 201.5; 201.128. Promotion of OTC Plan B to women under the age of 16 would create an unapproved new drug, as would sale of the product "for a purpose for which it is neither labeled nor advertised" by persons legally responsible for its labeling. 21 CFR 201.128.
Commenter Organization Name: Pfizer, Inc.
Comment Number: 2005N-0345-C407
Excerpt Number: 5
Excerpt Status: NEW
Excerpt Text:
2. The drug will be marketed to a subpopulation requiring the supervision of a licensed practitioner. Simultaneous Rx/OTC marketing may occur where the manufacturer seeks to label and sell a formulation to a population which includes a sub-population which FDA determines cannot use the drug safely without the supervision of a licensed practitioner but can use it safely on an "Rx-only" basis. In addition, if FDA determines either initially or in a subsequent 503(b)(3) rulemaking that no "Rx-only" designation is required for use by a subpopulation and the manufacturer exercises its right to confine distribution of one or more such formulations to prescription status, simultaneous Rx/OTC marketing is authorized.
As noted in the ANPRM, FDA's determinations under 503(b)(1) and 503(b)(3) may take into account "meaningful differences" in indications for use, active ingredient levels, dosage forms and routes of administration. [Footnote 14: Advanced Notice of Proposed Rulemaking, 70 Fed. Reg. at 52051.] Unless those differences lead to an "Rx-only" determination, however, the ultimate decision on prescription versus OTC marketing lies with the manufacturer.
Commenter Organization Name: Pfizer, Inc.
Comment Number: 2005N-0345-C407
Excerpt Number: 7
Excerpt Status: NEW
Excerpt Text:
C. The ANPRM last inquires whether FDA would be able to enforce, as both a matter of law, and a practical matter, a limitation on OTC sales of a product to a particular subpopulation. FDA's ability to enforce such limitation is based on its authority under the Federal Food, Drug, and Cosmetic Act.
FDA is authorized and mandated under Section 502(f) to ensure that OTC labeling permits a drug product to be used safely. [Footnote 15: 21 U.S.C. § 352(f).] If the product labeling does not adequately inform the intended population (or a specific and targeted subpopulation) of a known vulnerability, FDA can and should require an appropriate label modification to ensure that the directions are adequate. FDA is, in fact, working on standards which will better communicate risks and use instructions to all consumers. [Footnote 16: See, e.g., FDA, Guidance, Useful Written Consumer Medication Information (CMI) (draft posted May 25, 2005), available at http://www.fda.gov/cder/guidance/6520dft.pdf; FDA, Guidance for Industry, Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements (draft posted Feb. 4, 2004), available at http://www.fda.gov/cder/guidance/5669dft.pdf.]
When FDA is satisfied that the label properly communicates to the relevant subpopulation an effective warning, use contraindication, or other significant safety information it has fulfilled its Congressional mandate and reached the limit of its authority.
Commenter Organization Name: Duramed Research, Inc. and Duramed Pharmaceuticals, Inc.
Comment Number: 2005N-0345-C415
Excerpt Number: 13
Excerpt Status: NEW
Excerpt Text:
Thus, for example, if a drug is indicated only for an adult population, but is promoted by its manufacturer for a pediatric population, the manufacturer would be subject to a charge under section 301(d) as well as to a charge under section 502(f)(1), The availability of a new-drug charge in this type of situation demonstrates conclusively that a drug intended for one patient population is a different new drug from the otherwise identical drug intended for a different patient population. In the language of section 310.3(h)(4), the difference between the intended patient population creates a different "use" of the drug -even though, in all other respects, the drug's physical qualities and its conditions of use (e.g., the medica1 condition it is intended to treat) remain the same. [Footnote 17: In the terms of FDCA § 201(p), 21 U.S.C. $ 321(p), the difference in intended patient population constitutes a difference in "the conditions prescribed, recommended, or suggested" for the drug. ]
Therefore, where intended patient populations are sufficiently distinct that FDA has concluded, on medical grounds, that one and the same product (i.e., same ingredients, dosage form, route of administration, strength, etc.) should be available OTC for one subpopulation of patients but only Rx for a second subpopulation, the uses of that product for the different subpopulations are different; and therefore the product, as intended for the different subpopulations, is, technically, two different new drugs. [Footnote 18: Patient populations can be differentiated on a variety of bases - including disease state, experience with other drugs, and gender, as well as age. ]
Commenter Organization Name: Duramed Research, Inc. and Duramed Pharmaceuticals, Inc.
Comment Number: 2005N-0345-C415
Excerpt Number: 19
Excerpt Status: NEW
Excerpt Text:
A. AS A MATTER OF LAW, FDA CAN ENFORCE LIMITATION OF AN OTC PRODUCT TO A PARTICULAR SUBPOPULATION THROUGH ENFORCEMENT OF SECTION 503(B)(1)(B).
Just as it has the legal authority to enforce a prescription limitation where the limitation applies to the entire population, FDA has the legal authority to enforce the prescription limitation of Plan B as to a subpopulation (i.e., women 15 and younger).
Section 503(b)(1)(B) of the FDCA provides:
A drug intended for use by man which . . . is limited by an approved application under section 505 to use under the professional supervision of a practitioner licensed by law to administer such drug; shall be dispensed only (i) upon a written prescription of a practitioner licensed by law to administer such drug, or (ii) upon an oral prescription of such practitioner which is reduced promptly to writing and filed by the pharmacist, or (iii) by refilling any such written or oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filed by the pharmacist. The act of dispensing a drug contrary to the provisions of this paragraph shall be deemed to be an act which results in the drug being misbranded while held for sale.
21 U.S.C. § 353(b)(1)(B) (emphasis added).
In turn, section 301(k) provides that the following is a prohibited act: "The . . . doing of any other act with respect to, a food, drug, device, or cosmetic, if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being adulterated or misbranded." 21 U.S.C. § 331(k).
Injunctive relief for violation of section 301(k) is available under FDCA § 302.21 U.S.C. § 332. Criminal penalties for committing a prohibited act under section 301(k) are available under FDCA § 303(a), 21 U.S.C. § 333(a).
Reading these three sections together, "the conclusion is inescapable . . . that one dispensing drugs . . . contrary to the provisions of Sec. 353(b)(1) shall be guilty of, and subject to the punishment provided by law for, an act of misbranding." United States v. Carlisle, 234 F.2d 196,199 (5th Cir. 1956). Thus, if FDA approves Duramed's supplement to NDA 2l-045/S011, permitting OTC sale for those age 16 and over and requiring a prescription for sale to those under age 16, then selling to someone age 15 or younger without a prescription would constitute a prohibited act under section 301(k), for which civil and criminal remedies are available under the FDCA.
Commenter Organization Name: American Pharmacists Association
Comment Number: 2005N-0345-EC16675
Excerpt Number: 18
Excerpt Status: NEW
Other Sections: NEW - 3.3.3 - Other arguments related to FD&C Act
MODIFIED - 7.3.1.3 - Require risk management program
Excerpt Text:
If the FDA approves a product for inclusion in the Pharmacy Care OTC category or for placement within a statutorily-established expansion of the drug classification system, either option could be supplemented, when necessary, with some form of postmarking risk management program. Subpart H of the Act gives the Agency the authority to approve a product with restrictions to assure safe use "if the FDA concludes that a drug product shown to be effective can be safely used only if distribution or use is restricted." [Footnote 6: 21 CFR 314.520] The restrictions can include distribution restricted to certain facilities or physicians with special training or experience; distribution conditioned on the performance of specified medical procedures; or limitations imposed that are commensurate with the specific safety concerns presented. [Footnote 7: Ibid.] The Agency can place these postmarketing restrictions on both prescription and OTC products. The Agency could use its authority under Subpart H to require a risk management program - such as distribution restricted to a pharmacy or entities with a pharmacy or requiring additional education on product use - for products that have been approved with a dual status because the Agency has concluded that the drug may only be safely used in a particular subpopulation as a prescription product.
Commenter Organization Name: National Research Center for Women
Comment Number: 2005N-0345-EC2314
Excerpt Number: 9
Excerpt Status: NEW
Other Sections: NEW - 6.1 - Yes
NEW - 6.4.1 - Nicotine replacement therapy (e.g., Nicorette)
Excerpt Text:
The Office of Chief Counsel has previously determined that age restrictions for an OTC product are legal, as in the case of Nicorette nicotine replacement therapy. Furthermore, there is no indication that counsel was concerned that such a restriction would be unenforceable. A document regarding the approval of Nicorette for OTC status states:
Furthermore, the OGC has provided us with a legal opinion that it is possible under the FC&C act to impose restriction on the sale of the product to minors, if such restrictions are needed to ensure their safety.
The FDA?s decision that it has the authority to restrict the sale of OTC products to minors in the case of Nicorette applies with equal and full force to Plan B. While we disagree with the FDA?s view that Plan B has not been proven safe for the restricted age cohort, FDA has, on advice of its own counsel, made exactly the same kind of age distinction for Nicorette as it can make for Plan B in approving the drug for OTC use.
6.3.2 - No laws prevent the policy
Commenter Organization Name: American Society for Reproductive Medicine
Comment Number: 2005N-0345-C350
Excerpt Number: 5
Excerpt Status: NEW
Other Sections: NEW - 3.3.2 - FD&C Act is clear regarding when a drug should be prescription only
NEW - 3.6.2 - Court case arguments opposing a rulemaking
Excerpt Text:
A. FDA's Legal Authority is Clear and Supports Approval
No statutory provision prevents FDA from imposing an age limitation on the prescription drug status of a new drug. As a fundamental matter, the FDCA presumes that a new drug may be available OTC unless it falls within the definition of a prescription drug in Section 503(b) of the Act. 21 USC 353(b). See, e.g., 21 CFR 330.10(a)(4)(vi); see also Leg. Hist. of Durham-Humphrey Act at S. Rep. No. 946, at 1951 USCCAN 2454, 2461. Section 503(b) provides that FDA shall impose a prescription-only restriction where a new drug
because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug.
Thus, the statute allows FDA to determine, based either on the data contained in the sNDA or the lack of necessary data, that Plan B poses a "potential for harmful effect" if used in women under age 16. FDA could also find that "collateral measures" are necessary for its safe use by women under age 16 - namely that distribution be limited to circumstances where a licensed practitioner is available to supervise its use. [Footnote 3: Indeed, the statute is silent with respect to whether age is a relevant factor when interpreting and applying section 503(b). Thus, under settled legal principles, the agency may "fill the gaps" in the statute through reasonable interpretation. See US. v Mead Corp., 533 U.S. 218,234 (2001); Chevron, USA., Inc v Natural Resources Defense Council, Inc , 467 U.S. 837 (1984).]
Commenter Organization Name: Roettcher, Phil
Comment Number: 2005N-0345-EC224
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 1.2.1 - Approve for OTC for all
Excerpt Text:
I see no reason why a single molecule cannot be sold in two different formats though I would prefer you follow the advice given by your medical staff that Plan B medications are safe for all women of child bearing age.
Commenter Organization Name: Venturella, Vincent
Comment Number: 2005N-0345-EC58
Excerpt Number: 4
Excerpt Status: NEW
Other Sections: NEW - 6.1 - Yes
Excerpt Text:
I do not see any deviation from the law(s) available to the FDA under the current FD&C Act that would prevent it from instituting this policy.
6.3.4 - Age limitations are in line with other meaningful differences
Commenter Organization Name: American Society for Reproductive Medicine
Comment Number: 2005N-0345-C350
Excerpt Number: 8
Excerpt Status: NEW
Other Sections: NEW - 3.9.1 - Drug approval examples
Excerpt Text:
As the agency recognized in the September 1 ANPR, FDA has allowed marketing of the same active ingredient in products that are both prescription and OTC where "some meaningful difference exists between the two that makes the prescription product safe only under the supervision of a licensed practitioner." 70 Fed. Reg. 52050 (Sept. 1, 2005). FDA provided several examples of such drugs, and reiterated that the "key distinction" between the OTC and prescription versions of those products is "some meaningful difference between the two products," for example, "indication, strength, route of administration. dosage form." Id.
Commenter Organization Name: American Society for Reproductive Medicine
Comment Number: 2005N-0345-C350
Excerpt Number: 9
Excerpt Status: NEW
Other Sections: NEW - 3.3.3 - Other arguments related to FD&C Act
Excerpt Text:
A drug product is approved for those uses set forth in its labeling, the scope of which is limited to specific statements about the "conditions" of its proper use - those "prescribed, recommended, or suggested" in the labeling. 21 USC 355(d)(1). Thus, labeling that includes specific limitations on the appropriate patient population for which the drug is intended can denote a "meaningful difference" in the prescription drug and the OTC drug product. [Footnote 4: In June 2005, FDA approved a drug for use only in a specific subpopulation -African Americans. The drug, BiDil(R) (hydralazine hydrochloride; isosorbide dinitrate), is indicated for the treatment of heart failure as an adjunct to standard therapy in self-identified black patients. ] Quite simply, levonorgestrel labeled for prescription use is a different drug that levonorgestrel labeled for OTC use. Indeed, as FDA. acknowledges, it has approved OTC and prescription versions of a product based on differences in "indication," which constitutes a meaningful difference in the two products' intended or labeled uses.
ASRM believes that FDA has ample authority to make a similar distinction between prescription and OTC levonorgestrel and should do so immediately.
Commenter Organization Name: Duramed Research, Inc. and Duramed Pharmaceuticals, Inc.
Comment Number: 2005N-0345-C415
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 7.3.1.2 - Require retailer, pharmacist, and consumer education programs
Excerpt Text:
2. FDA has authority to enforce the limitation of Rx products to a subpopulation, just as it has authority to enforce the limitation of Rx products by indication, strength, route of administration, and dosage form. Moreover, FDA can enforce this limitation in actual practice through a variety of mechanisms, including, but not limited to, random inspections of pharmacies by FDA investigators and coordination with state and local law enforcement officials. To aid in FDA's efforts, Duramed has proposed a marketing program for Plan B that will include limiting distribution of Plan B to retail operations with pharmacy services and clinics. It will also include an educational component to help ensure the compliant, safe and effective use of Plan B. This program would be designed to educate pharmacists and health care practitioners on the Rx requirement for women age 15 and younger. It will also educate women age 15 and younger to discuss Plan B with their health care practitioners.
Commenter Organization Name: Duramed Research, Inc. and Duramed Pharmaceuticals, Inc.
Comment Number: 2005N-0345-C415
Excerpt Number: 18
Excerpt Status: NEW
Excerpt Text:
II. FDA CAN ENFORCE LIMITED SALE OF AN OTC PRODUCT TO A PARTICULAR SUBPOPULATION.
As the Notice highlights, there is nothing novel about an active ingredient that is marketed simultaneously in both an Rx drug product and an OTC drug product. FDA has repeatedly approved such simultaneous use where there is, as FDA states in its Notice, "some meaningful difference . . . between the two that makes the prescription product safe only under the supervision of a licensed practitioner." 70 Fed. Reg. at 52051. That the meaningful difference is in the population taking the drug, and not in the active ingredient, itself, has no impact on FDA's legal and practical ability to enforce the prescription requirement while permitting OTC sales of a drug with the same active ingredient.
Commenter Organization Name: Black, Jerrold
Comment Number: 2005N-0345-EC111
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text: