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 : EC731
Submitter : Mr. Peter Gummere Date & Time: 10/13/2005 08:10:49
Organization : Mr. Peter Gummere
Category : Health Professional
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?

NO! The pharmaceutical in question will have impact far beyond the immediate use of the product. There is a growing body of literature indicating that physchological consequences of elective termination of pregnancy. These complications include increased lifelong risk of depression, post traumatic stress disorder, substance abuse, etc. Having a pharmaceutical agent capable of terminating a pregnancy available OTC places women at increased risk of serious illness. Doing this without benefit of competent professional support is absolutely unethical.

No grave harm would happen to the manufacturers if Plan B is not licensed for OTC use. Potential exists for grave harm to women, particularly young women, who use the product.
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?
NO! The potential for abuse is great. We know all too well about minors obtaining products prohibited to them (e.g. alcohol and cigarettes) through older friends. I am afraid that such a rule would simply create a new class of product which would be obtained illegally by some teenagers.

B. If it could, would it be able to do so as practical matter and, if so, how?
MANDATORY INCARCERATION for persons who traffic in such product illegally or who distribute it to underage persons.
I fear that we continue to undermine the public good by sanctioning the elective termination of pregnancy in such a casual manner.