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 : EC759
Submitter : Dr. Susan Yoshihara Date & Time: 10/13/2005 08:10:29
Organization : Dr. Susan Yoshihara
Category : Academia
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, it should not. The FDA should not approve this product for over the counter sale.
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, it should not.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
No, it is very clear, but it is ducking the central issue and that is the health and safety of the patients involved. FDA's focusing on the law and not on health in this matter is highly premature.
C. If so, would a rulemaking on this issue help dispet that confusion?
Rulemaking in this case would lead to more confusion about this product and the policy issues surrounding its use and endorsement by the federal government.
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, it would.
B. If it could, would it be able to do so as practical matter and, if so, how?
Yes, valid I.D. and parental involvment under the age of 18.
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?
Anything can be legalized, but that does not make it prudent or ethical. By insisting upon 'expediting' this matter without sufficient public scrutiny, you give lie to your claim to encourage public discussion.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
It would be inappropriate to sell or distribute this product in the United States. There is not definitive evidence that it does not harm the mother. Nor is there evidence that it may in some cases, no matter how rare, act as an abortafacient.
GENERAL
GENERAL
The manner in which you are rushing this drug onto the market is irresponsible. In the case of a potential abortafacient, you bear the burden of proof that it is a drug to make people healthy and not a drug that causes direct harm to mother or child in its earliest stages of life. You cannot elude this issue, no matter how much you may wish to avoid it. The American public has a right to ALL of the facts of this case and you must provide them. Furthermore, there is no reason to rush this product to the market. There is no public health epidemic, for example. Prudence lies in taking the time to allow the people to deliberate on ALL of the facts. Do not obscure them. Rather, do the right thing and allow us to make an informed choice in this matter.