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 : EC808
Submitter : Mr. Steven Goranson Date & Time: 10/13/2005 09:10:15
Organization : Mr. Steven Goranson
Category : Individual Consumer
Issue Areas/Comments
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?
there is no need in my mind to have both drug products as OTC and prescription. If it is safe as an OTC where is the need to have it regulated for consumer usage by a doctor's consent? I see no reason for any modification to section 503(b).
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?
It is difficult enough for the retail market to curtail under-age buying of and consumption of alcohol let alone for pharmacy personel to check for a female under the age of 16 to buy a morning-after abortifacient using a false ID. Enforcement would be difficult and to allow OTC sales of a morning-after pill would lead to more teen-age pregnancies, STDs and other social problems.
B. If it could, would it be able to do so as practical matter and, if so, how?
People who would circumvent laws always try to find ways to do so. If someone can get a false ID there is usually someone who will try to get around those laws and regulations. The penalties for violating those regs should be stiff in order to deter those violations. Education of store personell of the penalties for selling to under-age individuals of a subpopulation group would help deter violations.
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?
I think that would be alright.
If the FDA thinks it will be alright for a teen to buy a morning-after pill, they are wrong. Many women who have used somthing like RU-481
have experienced complications like excessive bleeding and even death. Imagine the trgaic loss of life and the lawsuits that would follow if a morning-after pill was sold as an OTC.