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 : EC774
Submitter : Dr. Michel Glower Date & Time: 10/13/2005 08:10:07
Organization : Dr. Michel Glower
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
After reading the questions on this page, it is apparent that the FDA is turning the important issue of safeguarding women's health into one of technical legal-wrangling. Not since President Clinton discussed the meaning of the word "is" have I seen an issue so obscured by legalese.
The important issue here is that women in the U.S. should have the same ability to safeguard their own health as women in many other countries. Unintended pregnancy can be a major threat to women's health and well being. The sooner "Plan B" is taken, the more certain and safely an unwanted pregnancy can be prevented. Timely access to Plan B would be insured by making it available over the counter. The product is safe and currently available by prescription, and is widely used to prevent unintended pregnancy. Please follow the science and allow Plan B to be sold over the counter.
Again, it is a national shame that the FDA is actively participating in a plot to harm the health of American women for political gain.