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 : EC1027
Submitter : Ms. Kristin Dahling Date & Time: 10/27/2005 10:10:00
Organization : Ms. Kristin Dahling
Category : Individual Consumer
Issue Areas/Comments
As someone who is concerned about women?s access to safe and medically necessary contraceptives, I urge the FDA to end its egregious delay of the decision to switch Plan B?s drug status to over the counter (OTC).

For Plan B to be effective, women must be able to take it quickly, as the efficiency rate decreases dramatically after 12 hours following unprotected sex, birth control failure or sexual assault. A doctor's prescription does not affect this in any way, other than to delay women who need Plan B, making it less effective. Because it is often not possible to quickly schedule an appointment with a health-care provider who will write a prescription, making the drug available OTC is essential to the many women who would not otherwise be able to access it.

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. 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.

The FDA has long been hailed as an independent entity that promotes public health through science and evidence, not ideology and politics. The fact that women have had to wait for more than two years for the FDA to issue a decision on the Plan B application is unacceptable. Please make women?s health the FDA?s first priority by ending this undo delay.

Thank you for your consideration.