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 : EC1040
Submitter : Ms. DEBRA MEAGHER Date & Time: 10/27/2005 10:10:17
Organization : Ms. DEBRA MEAGHER
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?
THE FDA SHOULD DO WHATEVER IS NECESSARY TO APPROVE PLAN B EMERGENCY CONTRACEPTION AND MAKE IT IMMEDIATEY AVAILABLE OVER THE COUNTER AVAILABILITY TO ANY WOMAN WHO WISHES TO PURCHASE IT. A WOMAN'S HEALTH AND WELL BEING SHOULD NOT BE COMPROMISED BY WHAT THE PUBLIC WOULD VIEW AS MARKETING TECHNICALITY.
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
WHAT IS CONFUSING IS WHY THE FDA HASN'T APPROVED THIS DRUG YET.
2
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?
WHY SHOULD THERE BE LIMITATIONS? NO ONE IS GOING TO BE FORCING ANYONE TO TAKE THIS DRUG. IF YOU DON'T WANT IT WHY SHOULD YOU BE OPPOSED TO ANYONE ELSE TAKING IT? ISN'T THAT THE SAME WITH ANY DRUG? IN THIS CASE I DON'T THINK ENFORCEMENT WOULD BE WORTH THE RESOURCES THAT WOULD BE SPENT.
B. If it could, would it be able to do so as practical matter and, if so, how?
I THINK THE FDA SHOULD DIRECT IT'S EFFORTS TO COCAINE AND METH USE-DRUGS THAT ACTUALLY HAVE A NEGATIVE EFFECT ON THE ENTIRE POPULATION
3
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?
WHATEVER. THIS IS A NON ISSUE.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
NONE
GENERAL
GENERAL
THERE DOESN'T SEEM TO BE ANY REASON THE FDA HAS NOT APPROVED PLAN B EMERGENCY CONTRACEPTION FOR OVER THE COUNTER SALE. THIS SHOULD HAVE BEEN A FAST TRACK APPROVAL. WHY SHOULD AMERICAN WOMEN BE DENIED THE USE OF A SAFE DRUG BECAUSE OF POLITICAL RHETORIC? THAT HAS NOTHING TO DO WITH SCIENCE OR MEDICINE AND DEBASES THE STATURE OF THE AGENCY.