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 : EC1007
Submitter : Mrs. Lisa Rentz Date & Time: 10/27/2005 09:10:06
Organization : Mrs. Lisa Rentz
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
I have been following Plan B in the news, and it is obvious that the FDA has not been acting with concern for health, but has instead been corrupted by politics and and this new, unfortunate trend of appointing leaders who are incompetent and incompatible with their mission. The FDA can fix this trend by approving Plan B's status as an over the counter drug. Tax-paying, voting citizens are adults, the same adults who already manage their health and happiness. I personally regard governmental attempts to deny anything to adults an act of canceling our freedoms, denying our liberties, and as kind of moral slavery. Plan B should be made available OTC to women of all ages. The claim that easier access to young women will result in increased rates of unprotected sex among adolescents is simply unsubstantiated, and also unrelated to the fact that Plan B will benefit many people, as well as being an morality issue unrelated to the FDA. Moreover, the FDA has always treated all women of child-bearing age the same when evaluating reproductive health products, making the option of restricting OTC drug status by age an unjustified aberration. Such a restriction would only make it more obvious that decisions such as blocking OTC Plan B are in essence just another case of discrimination. I will continue following Plan B in the news, and sincerely hope that the FDA will finally starting doing a better and more honest job, hopefully setting an example for the rest of our deeply dispointing federal bureaucracy.