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 : EC620
Submitter : Ms. Marie Fordtner Date & Time: 10/12/2005 06:10:38
Organization : Ms. Marie Fordtner
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?
No. Because in countries where it was available, men wanting sex with younger girls were the ones buying the pill. It was intended for married women who forgot their birthcontrol and knew if they were in a fertile period. Young immature females using it repeatedly during the month would have side effects no one knows. It could be a breast cancer risk increasing behavior.
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, this would be a bad precedent.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
No.
C. If so, would a rulemaking on this issue help dispet that confusion?
No not necessary.
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?
Accutane has caused birth defects and many safeguards such as tracking patients have been started. At least these safeguards should be in place.
B. If it could, would it be able to do so as practical matter and, if so, how?
The accutane safeguards would be the least, and would not protect girls from repeated rape and incest incidents. STD's would increase since male partners who don't respect women's fertility in the first place would have no incentive for condoms.
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?
Why bother with the prescription which could be paid by insurance and raise everybody's insurance? What doctor would prescribe morning after pills to men? And hopefully the girls doctor would give some advice about the circumstances, such as STD's, cancer, etc.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Sales to men and boys should mention that pregnancy rates go up when the morning after pill is used.
Sales to women should contain different warnings, phone numbers for pregnancy support, state garnishment of wages for fathers to provide for babies and mothers care, to care for them and their baby when the pregnancy starts anyway.