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 : EC2165
Submitter : Dr. William Leininger Date & Time: 10/31/2005 06:10:49
Organization : Dr. William Leininger
Category : Health Professional
Issue Areas/Comments
As an Ob/Gyn, I prescribe Plan B for my patients regularly, and would prefer for them to have even greater access to it.

The science is clear that Plan B use has almost no risk, and has enormous benefit. As for girls younger than 16 being able to use it correctly, if safety of use is a concern, then there are several other OTC medicines that are much more dangerous than Plan B. Additionally, the under 16 population has an even higher risk of complications from pregnancy, and needs even more protection.

Plan B and other forms of emergency contraception are medicines that can prevent a condition (pregnancy) that has far higher risks associated with than any reasonable misuse of the medicine. Expediting its widespread availability fulfills the FDA's purpose in ensuring the safety and effectiveness of medicines, in support of promoting health in the United States.