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 : EC1359
Submitter : Dr. William Falls Date & Time: 10/28/2005 03:10:57
Organization : Dr. William Falls
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?
FDA created this issue itself. It should stop delaying and approve OTC sale of emergency contraception (EC) as recommended by its scientific panel: without an age restriction.

If FDA is unwilling to do so it should approve OTC sale to adult women as FDA forced the manufacturer to propose. That happened months ago, and another delay for so-called "rulemaking" is simply dishonest.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
There was no confusion until FDA created it this year, by ignoring scientific evidence and manufacturing pretexts for one delay after another. So yes, there is huge confusion as to FDA's interpretation, not as to the obvious propriety of its approving OTC sale of EC medications.
C. If so, would a rulemaking on this issue help dispet that confusion?
No, a rulemaking would serve only to prolong the delay of approval as FDA is clearly seeking to do.
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 has no business enforcing the gratuitous restriction it is trying to impose on women. Of course it could do so, as other agencies do for tobacco and alcohol, but it has no sound basis in science and no mandate in law to do so in the case of EC.
B. If it could, would it be able to do so as practical matter and, if so, how?
FDA should NOT do so. ID checks for EC have nothing to do with protecting health, the mission of FDA. They are intended only as a barrier and an embarrassment for young women who are sexually active anyway. Its only practical effect will be an increase in unwanted pregnancies and abortion.
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?
The split between prescription and OTC sale is a creation of certain individuals in FDA and has no basis in fact. It should not exist, and so separate packaging should not be required.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
There are not two products but one. The distinction is an FDA creation for which no foundation exists in science or reason, so this question is inappropriate.
We have trusted FDA for years. It protected us from Thalidomide and from phony cancer cures. Now it is throwing away our trust. Please withdraw from the dangerous and absurd path you have embarked on this year in your handling of OTC sale of emergency contraception medications.