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 : EREG23
Submitter : Mr. Judith Mclane Date & Time: 10/03/2005 03:10:59
Organization : Generation Life
Category : Other Organization
Issue Areas/Comments
I am writing to voice my opposition to making the Morning After Pill available over the counter. Emergency contraception is a high dose of steroid female hormones. This is just a higher dose than oral contraceptives, which are PRESCRIPTIVE only. How can you make available a drug that is more dangerous than one that is "prescriptive only", over the counter. Plus, there have been NO testings done to confirm the safety of these large doses of birth control pills on women. The World Health Organization declared combined estrogen-progestogen oral contraceptives as carcinogenic. The International Agency for Research on Cancer placed the contraception into Group 1 classification, the HIGHEST classification of carcinogenicity, used only "when there is sufficient evidence of carcinogenicity in humans. Emergency contraception (Plan B) is hurting women! If these drugs are made available over the counter..not only are women at stake..but now our children will be as well!! I beg you to deny this request. Thank you for your consideration.
Judith McLane