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 : EC795
Submitter : Mrs. Sarah Timberlake Date & Time: 10/13/2005 08:10:21
Organization : Mrs. Sarah Timberlake
Category : Individual Consumer
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?
In the case of Plan B Emergency Contraception, the FDA should approve OTC sale of this drug regardless of age. Enforcement of an age limit under which the drug is available by prescription only would be possible if consumers younger than the minimum age had ID to present. Driver licenses are only available for ages 15 and up but they can be forged relatively easily. However, the scientific and medical evidence supports allowing women of all ages OTC access to Plan B.
B. If it could, would it be able to do so as practical matter and, if so, how?
As stated in 2A: Enforcement of an age minimum for OTC access to Plan B would be hindered by the ability of younger consumers to forge identification. Another problem would be that elder consumers may purchase the OTC drug and give the drug to younger consumers. HOWEVER, there is no good reason why young women should be denied OTC access to Plan B. These are the young women who are at greatest risk for unintended pregnancy, followed by either abortion or a continuation of the cycle of young single parenthood and poverty.
Dear Mr. Von Eschenbach:

I strongly urge the FDA to grant over-the-counter status for Plan B emergency contraception for women of all ages. Women in the U.S. -- single, married, victims of rape, and of all economic backgrounds -- deserve the same unencumbered access to Plan B that women in 39 other countries already have. As a volunteer in a family planning clinic I see the emotional and physical results of forgotten or failed primary contraception on a weekly basis. I can speak from my professional and personal experience to the fact that Plan B drastically reduces the rate of unintended pregnancies and the use of abortion. Its success with these two achievements would be significantly improved if women were given broader, more immediate access ? if they did not have to schedule an appointment to obtain a prescription, or wait for a clinic to open after a weekend or holiday to obtain this safe and easy to use drug, since its effectiveness is highest 3 days after intercourse.

It is truly shameful that the FDA is allowing political pressure and ideology to supercede its science-based decision making. Major medical groups and the FDA?s own experts fully support offering Plan B over the counter. I urge the FDA to return to an independent stance and begin again to make public health decisions that are based on sound scientific and medical evidence, rather than political or religious agendas.

Sarah Timberlake
Research Technician, Duke University Medical Center
Master of Public Health Student, University of North Carolina at Chapel Hill
Concerned citizen and voter