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 : EC2092
Submitter : Dr. Christopher Moss Date & Time: 10/31/2005 06:10:57
Organization : Dr. Christopher Moss
Category : Individual Consumer
Issue Areas/Comments
I object in the strongest possible terms to the FDA's continued refusal to allow sales of emergency contraception without a prescription. Forcing women to get a prescription before they can obtain 'Plan B' is a disturbing and unnecessary burden on all women, but especially on poor women who may not have access to a physician. Moreover, requiring a physician's prescription increases the total cost of EC dramatically. Almost two years ago, your own expert advisory panel recommended by a 23-4 vote that EC be made available over the counter without prescription. Their stance is supported by numerous convincing, peer-reviewed studies. Your refusal to follow the advice of your own expert panel is a compelling example of why many Americans now correctly view the FDA as a body that is less concerned about health care than with politics. This is shameful.