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 : EC832
Submitter : Dr. Lisa Donovan Date & Time: 10/13/2005 10:10:46
Organization : Dr. Lisa Donovan
Category : Health Professional
Issue Areas/Comments
Dear FDA- My comment is a general one. There are many and varied acceptable answers and solutions for the above questions you pose. Concerns over differential sale based on age is clearly an artificial problem created by anti-abortion advocates in power in your agency. The assumption of pharmicist and parental responsiblility must be relied upon without regulations as it is for every other drug that would possibly be prescribed to or purchased by a minor. I merely want to remind you that the FDA is obligated to be guided by law and SCIENCE only. Abortion is guaranteed by LAW in this country still. The concerns of sale of Plan B emergency contraception to adolescents is not based on science, but rather political ideology only. Your own Advisory Committee conceded such in it's overwhelmingly positive ruling for the release of this medication from prescription control. Per your stated mission to serve the public health, not just the male half of the public, nor just the Christian Right part of the public, you must rule favorably on the OTC sale of Plan B emergency contraception. If even the FDA is held captive by political and religous ideology then there is no truly safe and free place for science and logical thought in our government. Don't hand over the best of our democracy so easily. Please follow the ethics of science and medicine and rule for the widest possible access of this safe drug without undue and negatively coersive regulations. The majority of Americans, who may be less vocal but are free-thinking, is watching your actions. Sincerely, Lisa Donovan MD