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 : EC2112
Submitter : Mrs. Judith Kaplan Date & Time: 10/31/2005 06:10:17
Organization : Women's Caucus for Art
Category : Consumer Group
Issue Areas/Comments
GENERAL
GENERAL

We support the health, safety and decision-making authority of women in their childbearing years and DEMAND that the FDA follow the medical and scientific advice of its committees and permit the sale of EC without a prescription, without age restrictions, and OVER the counter (not 'behind the counter' where we must beg a reluctant clerk or pharmacist to give it to us).
It is unreasonable and immoral for FDA to continue postponing this when all regular science, medical and policymaking procedures have been met.

Women have been waiting for over two years for the U.S. Food and Drug Administration (FDA) to allow Plan B, also known as emergency contraception (EC), to be sold over-the-counter without a prescription. This was supposed to be completed on September 1, 2005. Then,on August 26 the FDA said that they would prolong the decision period by more than 60 days in yet another unnecessary and demeaning example of catering to a fringe group of anti women!
This will save women's lives and prevent abortions! How can anyone be against it unless they are against women. Make this win-win decision and save lives and prevent abortions. Now the FDA should proceed with haste.



The vast majority of the public will not stand for this delay of women's rights. As activists who support the health, safety and decision-making authority of women in their childbearing years we DEMAND that the FDA follow the urgings of its own medical and scientific advisors on its committees and permit the sale of EC without a prescription, without age restrictions, and OVER the counter (not 'behind the counter' where we must beg a reluctant clerk or pharmacist to give it to us).
Judith Kaplan
Altamonte Springs FL 32714