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 : EC1389
Submitter : Ms. Beverly McPhail Date & Time: 10/28/2005 03:10:38
Organization : Ms. Beverly McPhail
Category : Federal Government
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?
FDA should not muddy the waters about providing legal and necessary health care for women that is well within our reproductive rights under the privacy clause of the Constitution by making this about packaging!!!
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?
The question here is whether emergency contraception should be made available OTC and the scientific community agrees that it should be done. People are quitting your agency in protest of these political decisions and delaying tactics.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
No, none whatso ever, it is just your agency that seems confused, not women, not scientists!
C. If so, would a rulemaking on this issue help dispet that confusion?
No
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?
Yes, this is done all the time with regards to alchohol, tobacco and other products.
B. If it could, would it be able to do so as practical matter and, if so, how?
Yes, as above, it is already quite commonly done. This area provides no exception.
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?
Again, you are blowing smoke trying to confuse the issue and make it about packaging.
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
This issue is not about packaging. It is about making a safe, legal product accessible to women so we might control our reproductive destinies. Women have the moral authority to make these decisions; your job is to give them the means to to do when the drug is determined to be safe. The safety has been conclusively proved, now please do your job.