FDA acted today to expand the availability of a product not based on a controlled safety and efficacy trial in the age group it expanded access to, but on the following evidence per their press release
““Research has shown that access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States,” said FDA Commissioner Margaret A. Hamburg, M.D. “The data reviewed by the agency demonstrated that women 15 years of age and older were able to understand how Plan B One-Step works, how to use it properly, and that it does not prevent the transmission of a sexually transmitted disease.”
The approval of Plan B One-Step for use without a prescription by women 15 years of age and older is based on an actual use study and label comprehension data submitted by Teva showing that women age 15 and older understood that the product was not for routine use and would not protect them against sexually-transmitted diseases. These data also established that Plan B One-Step could be used properly within this age group without the intervention of a health care provider”
As noted in a prior post. Plan B emergency contraceptive has not been studied in the age group that the FDA has just granted expanded access to. The agency cites that if you are 15 and older you can follow the instructions for using the medication properly. There’s a lot of instructions I can follow, does that mean I can now gain access to those drugs? Fascinating new criteria for drug approval.
Your thoughts on whether this was a political or scientific decision issued today?