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 : EC1362
Submitter : Dr. Erin O'Brien Date & Time: 10/28/2005 03:10:48
Organization : Univ. of California, Santa Barbara
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?
It should be approved immediately as an OTC for all age groups. Condoms and aspirin are not restricted to individuals of a particular age and my understanding of the studies on Plan B is that it is exceptionally safe and therefore should not be subject to additional restrictions.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
It appears that the FDA has used section 503(b) of the act as a delaying tactic as there is no scientific reasons (based on the findings of the FDA's independent scientific review) to not approve Plan B for OTC distribution.
C. If so, would a rulemaking on this issue help dispet that confusion?
This would only act to further delay the approval of Plan B as an OTC drug and as there is no scientific reason for delay, it is not needed.
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?
Is there any other drug for which there is different degrees of access for subpopulations? It seems to be a political issue to restrict access to this drug and not worthy of further consideration by the FDA.
B. If it could, would it be able to do so as practical matter and, if so, how?
I don't suggest even trying.
Given that Plan B has been shown to be an exceptionally safe and effective drug, it is inappropriate to delay approval of its designation as an OTC drug. Not only has it been shown to be safe; studies in Europe show that women can easily be educated about the appropriate use of the drug. To argue that keeping Plan B available only by prescription will force women to see their doctors is sexist as there is no equivalent restriction on safe drugs for men. Perhaps if our country is concerned about STD's and cancer screening we should also make condoms available by prescription only as men are clearly in need of similar medical attention than women given their shorter life spans.