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 : EC1557
Submitter : Ms. Stacey Paul Date & Time: 10/31/2005 11:10:53
Organization : Ms. Stacey Paul
Category : Individual Consumer
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?
No. These delay tactics will do nothing to change the overwhelming professional and medical expert recommendations, which are that emergency contraception be made available without restriction to women of all age as OTC product.
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
No. The only confusion is within the FDA itself. The public is quite clear on the issue.
C. If so, would a rulemaking on this issue help dispet that confusion?
A proposed rule with its lengthy comment and review process is being suggested only to drag out the time period before a final decision on EC - OTC is made. It is completely unnecessary.
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?
Of course not. All it would take is a fake ID. Furthermore it is obvious that such enforcement would violate EVERY WOMAN's civil rights. If a subpopulation were subject to limitations, then the ENTIRE population would be required to submit evidence that they were not part of the restricted populace. In other words, every woman wanting ECOTC would have to show identification proving they were not a minor. This would be a violation of her personal and medical privacy and would subject the woman to public censure for (presumably) engaging in activities that are entirely LEGAL.
B. If it could, would it be able to do so as practical matter and, if so, how?
The absurdity of this idea is impossible to exaggerate. Just play out the scenario: An adult woman wishes to purchase ECOTC. Although she is not part of the subpopulation, she is forced to submit identification to prove that is the case. This ID is reviewed by a drugstore salesperson, who has absolutely no training in the inspection of legal documents. The salesperson decides the ID looks fake and refuses to sell the product to the
woman. By the time the woman has filed a complaint against the store, and the case is investigated, it will be far, far too late for the woman to assert her civil rights and use the product. Furthermore, the FDA has no practical means of censuring the store or the salesperson for infringing upon the woman's rights.

Or try another scenario: an underage minor wishes to purchase ECOTC. She borrows her adult sister's driver's license and buys the product at a nearby drugstore. Or she obtains a fake ID from someone who knows someone.

In one scenario, the restrictions have infringe upon the rights of an individual, who, according the US Constitution, is entitled to make her own medical, social, and financal (purchasing) decisions. In the other scenario, the restrictions have been completely powerless to stop the individual the FDA claims it is attempting to protect.
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?
This question makes it obvious how far the FDA is bending over backwards to impose certain social and moral directives upon the people above and beyond that which the constitution allows.

Why ask all these twisting questions about different types of packaging? Just offer one product, over the counter, in one type of packaging.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Well obviously making the product available over the counter to everyone would eliminate any opportunity for inappropriate selling circumstances. It is never appropriate for a federal agency to regulate an indivuals recreational activities, or to assume that one's use of a purchased product is the result of certain presumed activities.