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 : EC1987
Submitter : Ms. Erin Price Date & Time: 10/31/2005 05:10:41
Organization : Ms. Erin Price
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?
The FDA should immediately approve over-the-counter sales of emergency contraception - with no prescriptions required for any age group. This obviates the need for any new rulemaking.

The apparent move by the agency to restrict access to women 16 years of age and younger contradicts the recommendations of the majority of respected medical professional associations, who make no distinction between post-pubescent adolescents and adult women where contraceptive use is concerned, as well as the government's own stated policy.
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?
The FDA should immediately approve over-the-counter sales of emergency contraception - with no prescriptions required for any age group. This obviates the need for any new rulemaking.

The apparent move by the agency to restrict access to women 16 years of age and younger contradicts the recommendations of the majority of respected medical professional associations, who make no distinction between post-pubescent adolescents and adult women where contraceptive use is concerned, as well as the government's own stated policy.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
The FDA's apparent intent to limit access to EC by age has muddled what should have been a clear- cut decision to approve over-the-counter sale of this safe, effective, and much-needed medication.
C. If so, would a rulemaking on this issue help dispet that confusion?
No. A "rulemaking" will become another stall tactic and is unnecessary. Approve EC for OTC sale now!
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?
The FDA's job is to determine safety and efficacy, not to serve as the "morality police" on behalf of any special interest group. Limiting sale of emergency contraception to young women is a bad idea, and it is simply inappropriate to deny young women the means to prevent pregnancy. Furthermore, asking for identification is both burdensome and unnecessary - and is an unacceptable intrusion on personal privacy with regard to medical care.
B. If it could, would it be able to do so as practical matter and, if so, how?
Such a move would be intrusive for all young women who would be required to show personal identification as a proof of age. The suggestion of federal enforcement brings to mind federal agents pursuing 16 year olds concerned about an unintended pregnancy who in the act of obtaining emergency contraception are breaking a federal law. The absurdity is hard to exaggerate.
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?
Making EC universally available would obviate the need for separate packaging.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
There would not be any circumstances that would be inappropriate for a single package.
GENERAL
GENERAL
The FDA's delay and ill-advised intention to restrict access to women 16 and younger is unacceptable and intolerable. Please make the decision to allow emergency contraception available to all women, all ages, no restrictions, and no proof of identity required!