2005N-0345 Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
FDA Comment Number : EC677
Submitter : Miss. Jennifer Gordon Date & Time: 10/12/2005 06:10:58
Organization : Miss. Jennifer Gordon
Category : Academia
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?
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.
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?
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.
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?
Without any real knowledge of law, I believe that a law must be reasonably enforceable to be real law. See below. 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.
B. If it could, would it be able to do so as practical matter and, if so, how?
Absolutely not. 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. 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.
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?
This 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.
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?
Above, I answer the questions which have been posed by the FDA. 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."