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 : EC1302
Submitter : Mrs. catherine broer Date & Time: 10/28/2005 12:10:09
Organization : Mrs. catherine broer
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 approve without further delay the over the counter sale of emergency contraception. No prescriptions required for any age group. This obviates the need for any new rulemaking.
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
The FDA's apparent intent to limit access by age has muddled what should have been a clear cut decision to approve over the counter sale of this safe and effective emergency contraception.
C. If so, would a rulemaking on this issue help dispet that confusion?
A proposed rule with its lengthy comment and review process is being suggested only to drag out the time period before a final decision on emergency contraception - over the counter is made. It is completely unnecessary.
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?
Limiting sale of emergency contraception is a bad idea. The FDA's job is to determine safety and efficacy, not the serve as the morality policy on behalf of any special interest group.
B. If it could, would it be able to do so as practical matter and, if so, how?
It is not against the law for 15 year olds to avoid pregnancy.
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?
Making EC universally available would obviate the need for separate packaging.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
There would be no circumstance in which it would be inappropriate for a single package.
GENERAL
GENERAL
I am disgusted with the cowardly behavior of the FDA