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 : EC2041
Submitter : Ms. Jude Vachon Date & Time: 10/31/2005 05:10:26
Organization : Ms. Jude Vachon
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?
All women, regardless of age, have need of access to emergency contraception as a matter of health. This is a health issue. The FDA found EC safe and effective in the past, there is no reason to delay the decision to provide it universally over-the-counter. If this decision is made, there is no issue as stated above.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Limiting access by age has confused and delayed what should be a clear-cut decision to provide over-the-counter sale of this safe and effective emergency contraception.
C. If so, would a rulemaking on this issue help dispet that confusion?
It's just 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?
If the FDA found EC to be safe and effective, then it needs to act on that knowledge and provide universal access regardless of age. It's healthcare that everyone, including young women, have the right to.
B. If it could, would it be able to do so as practical matter and, if so, how?
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?
EC should be universally available, in which case separate packaging would not be necessary.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?