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 : EC1227
Submitter : Mrs. Elaine Campbell Date & Time: 10/27/2005 05:10:39
Organization : Mrs. Elaine Campbell
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?
Another rule is ridiculous! You must approve the over-the-counter (OTC) sale of emergency contraception - with no prescriptions required for any age group. Two advisory FDA committees that exhaustively reviewed data in December 2003 found that emergency contraception was safe and effective and consequently recommended OTC approval. The FDA MUST continue the process and avoid this whimsical delay!

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
The Food and Drug Administration's apparent intent to limit access by age was not determined by science. Instead, the FDA has confused what should have been a clear- cut decision to approve over-the-counter sale of this safe and effective emergency contraception.

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?
This "rule making" is only an effort to further delay approval.
B. If it could, would it be able to do so as practical matter and, if so, how?
Federal enforcement of such a rule is impractical, intrusive and out-of-line.

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 is an unnecessary question!

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Good grief! Simply approve the obiously safe, medically recommended, needed drug, and stop playing games!
I am horrified that the FDA is playing politics rather than science. And they seem to be playing RELIGIOUS politics! This drug has been uninimously approved. Your head of FDA is making decisions based on nothing other than emotion.Complete the process now. No thinking person can suggest otherwise.