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 : EC2001
Submitter : Ms. Dorothy McClure Date & Time: 10/31/2005 05:10:41
Organization : Ms. Dorothy McClure
Category : Individual Consumer
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?
The FDA should approve WITHOUT FURTHER DELAY over-the-counter sale of emergency contraception-with no prescriptions required for any age group. The two FDA commitees that reviewed data in 2003 found this contraception to be safe and effective, and recommended approval.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
The FDA's apparent intent to limit access by age has muddled what should have been a clear-cut decision to approve over-the-counter sale of this safe and effective emergency contraception.
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 decision on Over the counter early contraception is made. It is not necessary.
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?
Asking for identification is burdonsome, unnecessary, sexist, and and is an unacceptable intrusion on personal privacy with regard to medical care. Limiting sale of emergency contraception to women of any age is a bad idea, and it is simply inappropriate to deny young women the means to prevent pregnancy.
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.
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 the early contraceptive 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.