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 : EC762
Submitter : Ms. Laura Jean Long Date & Time: 10/13/2005 08:10:06
Organization : Ms. Laura Jean Long
Category : Other Organization
Issue Areas/Comments
1
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?
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. 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).
1.
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?
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?
No, there is not significant confusion. 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.
C. If so, would a rulemaking on this issue help dispet that confusion?
I fear that rulemaking on this issue would only further codify the opinion driven barriers which prevent scientific recommendation from being heeded.
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?
No. 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.
B. If it could, would it be able to do so as practical matter and, if so, how?
It would not be able to do so as a practical matter. 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. 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.
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?
Yes they may legally sold in the same package. In fact, a more useful law would be one preventing pharmaceutical companies from artificially inflating the price of either the OTC or prescription version.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
I find no circumstances in which it would be inappropriate to do so.
GENERAL
GENERAL
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.