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 : EC2170
Submitter : Miss. Stephanie Whittle Date & Time: 10/31/2005 06:10:14
Organization : University of California Davis School of Medicine
Category : Health Professional
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?
I don't believe any such restrictions will make a difference. For example, if a drug like Plan B (emergency contraception) was restricted by age, a sexual predator could still buy it for a minor. This will in no way encourage or enforce doctors' and parents' involvement in a minor's health decisions.
I must respectfully but strongly disagree with supporting over-the-counter sale of Plan B (emergency conttraception). One important reason has more to do with protecting women that it does with any underlying belief system. Do you know there is an increasing amount of evidence that young women are more likely to be sexually active with overage men? This falls into the category of statutory rape, and I believe it is very important to consider this issue. You can verify this information by checking the following website: www.childpredators.com. Allowing even age-restricted access to this medication will only allow the exploitation of minors to continue because an overwhelming majority of the sexual predators are overage, and could buy these drugs for the young women. I beg this agency to please check this information out and think carefully about the consequences this will have.