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 : EC1155
Submitter : Ms. Cathy Girard Date & Time: 10/27/2005 04:10:23
Organization : NA
Category : International Public Citizen
Issue Areas/Comments
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?
FDA should absolutely NOT limit the sale to a certain subpopulation. It would be discriminatory to do so. There is no law that requires anorexics or bulemics to get a prescription before purchasing laxatives. Teens can buy cold medications (I swallowed a bottle of Sudafed and Bayer aspirin when I was 17 years old -- you don't hear anyone trying to legislate the sale of cold meds to children because they might take more than the recommended dose).

A young person does not have to show proof of age to buy condoms or contraceptive creams and yet they would have to get a prescription to prevent the pregnancy that may result from the failed use of those non-prescription OTC items?
B. If it could, would it be able to do so as practical matter and, if so, how?
Don't even ask this question! The philosophy behind the question is ludicrous! There is no need for parental consent to have sex or to buy contraception; why would a young adult need a parent's consent to prevent a potential pregnancy? Furthermore, not all parents can be consulted and some of the parents or the parents' friends/family are the perpetrators!

Young people have been sexual since the dawn of time; give them the tools and guidance they need to be responsible, sexual beings and most of them will do so. We should not punish the masses for the few. And besides, what are you trying to protect them from? Themselves? It's none of the government's business to do this.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
The FDA's failure to take a responsible stand on EC is a travesty to the American people and can be seen only as political maneuvering and personal agenda-pushing. EC should be made legal and available as an OTC medication. It's been sold as an OTC medication in Europe and
many other countries without incident. It is 89% effective in preventing unintended pregnancies and therefore reduce the abortion rate (which is the lowest its been in a decade). Many governments have been willing to ban Sudafed and other medications that are used in the the manufacture of meth, and yet what percentage of the population is making or using meth? The FDA has a duty to protect the US citizenry from unsafe drugs, not to administer conservative values based on a president's personal and political agenda. Please get out of our bedrooms and do your jobs: provide safe, timely, and effective medication to ALL people who need it.