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 : EC661
Submitter : Mrs. Barbara Gill Date & Time: 10/12/2005 06:10:14
Organization : none
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?
These two processes should remain separate. Regarding the case in question, pregnancy is not a cold or allergy, nor an upset stomach. A responsible adult is expected to take a contraceptive pill as directed. A child may take that same pill for expected results at inappropriate times, i.e., to preciptate an abortion far into the pregnancy rather than at its inception. There are also other considerations. Contraceptive pills are known to cause blood clots. Even for adults to be able to buy them OTC without a doctors direction can have dire consequences. Pills that cause a fetus to abort have not lowered the instances of abortions or STDs in areas where these problems have been studied. In fact, the instances of abortions and STDs has risen. It appears to me that the pills and condoms passed out to our youth only serves to give them a green light to become sexually active outside of marriage, something I do no want for my grandchildren.

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Apparently, if the FDA can't decide the difference between prescription and OTC.
C. If so, would a rulemaking on this issue help dispet that confusion?
That would be the purpose of the new rule.
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?
What would be the sense of calling it OTC if it is available to some by prescription? That part of the population to which it is OTC could easily provide it to the non-OTC population. So, no, it is not enforceable. And, again, what is to keep it from being misused?
B. If it could, would it be able to do so as practical matter and, if so, how?
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 not just hand them out at the door of the local Wal-Mart? How could there be any possible regulation, for example, at the checkout? The cashier wouldn't know if the pharmacy dispensed the item or not.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
When children can walk into the store and take the product off the shelf, pay for it, and walk out, go home and use it without supervision.
You have backed yourself into a corner on the subject of reproductive rights. You want to make abortion available to everyone. Abortion is a heinous crime against unborn children. If you are determined to go ahead with this scheme, at least protect the lives of those already born by limiting the use of a drug that can cause damage because of its multiple strength that is used to cause abortion and keep it under the use of women seeing a doctor and receiving medical care.