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 : EC1266
Submitter : Ms. BreAnne McConkie Date & Time: 10/27/2005 05:10:35
Organization : Ms. BreAnne McConkie
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?
The FDA should approve the over the counter sale of emergency contraception without any age limitations. There should be no need for new rulemaking, which only continue to exasterbate an issue that should be a personal choice and freedom extended to all, regaurdless of age.

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
The FDA's effort to enforce age limitation for EC has confussed what should have been a undebatable decision to approve the OTC sale of safe and effective EC.

C. If so, would a rulemaking on this issue help dispet that confusion?
The review and comment process is completely dragging out the decision.
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, they would as is currently seen with alcohol and tabacco sales. It is not the government's job to enforce moral standards, they are to promote personal freedom and choice without inhibbiting these values.
B. If it could, would it be able to do so as practical matter and, if so, how?
The idea that it would be illegal for an american citizen under the age of 16 to obtain EC is absurd. The denial of access for EC to any citizen, regaurdless of age, is an attempt to enforce personal values onto the citizen, inhibiting choice and individual freedom and rights.
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?
EC should be available OTC, eliminating the need for separate packages.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
in no circumstance
Emergency contraception should be a personal choice and freedom extended universally through making it available over the counter. Since it has been proven safe by the FDA, there should be no need for further discussion. The FDA is overstepping its appropriate boundries by denying personal choice to those without access to adaquate medical care,(perscriptions) and age. It would seem to me that as a nation founded on freedom and choice, no one should be denied these values. The FDA should approve EC for OTC, without promoting or dening its usage, let the people make the decisions for themselves.


BreAnne McConkie