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 : EC1504
Submitter : Ms. Janet Lorraine Date & Time: 10/28/2005 04:10:31
Organization : Ms. Janet Lorraine
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
On Sept. 26, the FDA delayed its decision on OTC access for Plan B emergency contraception to allow for a 60-day public comment period on the issue. I am writing to 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).

Background:

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. It seemed as though this decision would finally be made due to a strategic move made by Sens. Hillary Clinton (D-N.Y.) and Patty Murray (D-Wash.) who agreed to remove their "hold" on Lester Crawford's nomination to become Commissioner of the FDA in exchange for the promise of a decision on Plan B by September 1. However, on August 26 the FDA released a statement saying that they would prolong the decision period by more than 60 days in order to solicit public input on technical regulatory questions involving separate packaging and requiring prescriptions for young women 16 and under.

Lester Crawford has since resigned from the agency and the director of the National Cancer Institute (NCI), Andrew von Eschenbach, has become acting FDA commissioner. Von Eschenbach, a urologist, was a personal physician for George H.W. Bush ? another example of the cronyism that permeates this administration. Von Eschenbach was encouraged to step down from his job at the NCI, while he took the reins of the FDA because he could face conflict of interest charges as the FDA reviews drugs the NCI has helped develop. Whether von Eschenbach will help restore much of the lost respect for the FDA as a medical scientific organization of some integrity is questionable. In the meantime, von Eschenbach will be making the determination of whether emergency contraception is made readily available to women ? of any age.
I believe that the requested public comment period is a delaying tactic by the FDA to avoid having to make a decision - a decision that might enrage the administration's extremist anti-birth control supporters if they allow EC to be sold without prescription to all women of childbearing age. Polls show that a majority of the public supports emergency contraception and George W. Bush's anti-contraception advocates are far out of the mainstream. Any further delay in easing access to emergency contraception means thousands of unintended pregnancies.

These are anti-woman tactics. The vast majority of the public will not stand for this delay of women's rights. NOW activists and others who support the health, safety and decision-making authority of women in their childbearing years 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).
Very truly yours,
Janet Lorraine, 2003 Burbank Ave, Santa Rosa, CA 95407