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 : EC949
Submitter : Dr. James McBride Date & Time: 10/27/2005 08:10:33
Organization : Professor of Chemistry, Yale University
Category : Individual Consumer
Issue Areas/Comments
1
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?
Delaying approval of Plan B for over-the-counter status is unconscionable for the many reasons: 1. All scientific and medical evidence indicates that it is efficacious and safe. This should be the criterion for FDA approval. 2. As the father and grandfather of females I insist that female- specific medications and devices not face steeper hurdles than those faced by drugs for white males, like myself. 3. The availability of OTC emergency contraception will help prevent unwanted pregnancies that might otherwise result in abortion- consider cases of rape and incest. Public health decisions (and other scientific decisions) need to be made by independent governmental bodies that evaluate the scientific evidence and make decisions based on that evidence. To the extent that FDA is not strictly objective, it should be an advocate for women's health, not a challenge to it. Why is this question specific for this drug? (I suspect I know, but I'd like to have the upper eschelons of the FDA go on record on this subject.) 4. Why is the FDA trying to make access to the website for this public comment difficult? (Again, I suspect I know, but I'd like to have the upper eschelons of the FDA go on record on this subject.) 5. FDA should get out of the business of politics and morality for others and back into the business of protecting public health.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously market in both a prescription drug product and an OTC drug product?
No
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Only in so far as why Plan B, an emergency medication that could prove crucial some day for my wife, my daughter, or my granddaughters, should have raised the rulemaking query when the prescription-to-OTC procedure, when backed by sound scientific and medical evidence as is the case for Plan B, has moved smoothly in so many other cases.
C. If so, would a rulemaking on this issue help dispet that confusion?
Just approve the procedure for OTC and get out of my moral life.