Plan B for Plan B
From CQ.com:HHS Secretary Mike Leavitt on Monday defended FDA's action of indefinitely deferring a decision on Barr Laboratories' application for nonprescription sales of its emergency contraceptive Plan B, saying that he promised senators that the agency would act by Sept. 1 but never guaranteed a "yes or no" decision, Reuters reports (Heavey, Reuters, 8/29). FDA Commissioner Lester Crawford on Friday said the agency is opening a 60-day public comment period and did not give a timetable for a final decision on Barr's application. The agency in May 2004 issued a "not approvable" letter in response to Barr's original application to allow Plan B -- which can prevent pregnancy if taken within 72 hours of sexual intercourse -- to be sold without a doctor's prescription and in January delayed a ruling on Barr's revised application, which would allow EC to be sold without a doctor's prescription only to women ages 17 and older. As a result of the delay, Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) in June blocked a full Senate vote on Crawford's nomination for commissioner. However, the senators in July agreed to lift their holds after Leavitt in a letter to Sen. Mike Enzi (R-Wyo.), who chairs the Senate Committee on Health, Education, Labor and Pensions, said that FDA would act on Barr's application by Sept. 1. Crawford at a press conference on Friday said that science supported giving nonprescription access to Plan B to women ages 17 and older but added that the application presented FDA "with many difficult and novel policy and regulatory issues," including how to keep girls ages 16 and younger from obtaining the drug (Kaiser Daily Reproductive Health Report, 8/29).UPDATE: Steve Latham comments that: Susan F. Wood, Ph.D., Assistant
Leavitt Comments, Senators' Reaction
Leavitt on Monday said, "FDA made their commitment to me, and I made my commitment to the senators. The commitment was they would act. They did." He added, "Sometimes action isn't always yes and no. Sometimes it requires additional thought." However, Rodham Clinton and Murray in a joint statement said that Leavitt was playing "word games," adding, "A delay is not a decision, and no amount of semantics can change that" (Heavey, Reuters, 8/29). Leavitt said that in considering Barr's application, FDA found that "the science revealed significant policy questions that needed to be dealt with." He declined to speculate when FDA would issue a final decision on the application, CQ HealthBeat reports (Reichard, CQ HealthBeat, 8/29).
Commissioner for Women's Health and Director, Office of Women's
Health, announced her resignation over the Plan B issue yesterday. In
her resignation letter, she wrote: "I have spent the last 15 years
working to ensure that science informs good health policy decisions.
I can no longer serve as staff when scientific and clinical evidence,
fully evaluated and recommended for approval by the professional
staff here, has been overruled."
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"Word games," indeed -- not to mention that there is no _medical_ reason to worry about young women (under 17 years of age) getting their hands on Plan B. Of course, there are _political_ reasons, such as catering to those still in denial about teenage sexuality.
On strictly scientific grounds, there is no reason that Plan B should not be available OTC, pure and simple -- just like condoms.
- by Bob Koepp on Aug 31, 2005 at 4:30 PM | link
i suppose the worry is that that some would use this as an alternative to condoms. this product should not be advocated as part of "safe sex" (other than in emergencies) as its widespread use in casual context would likely contribute to increased STD risk. are there any studies showing harmful effects caused by repeated use?
in the case of teenagers, making condoms available but not Plan B is just not responsible. it certainly won't help bring down the rate of teen pregnancies to prohibit under-age use and there is no evidence teenagers will abuse the drug less than adults would. but fortunately if they need it they will be able to obtain it (they can successfully obtain cigarettes and alcohol under conditions of far less necessity)
- by NiK0 on Sep 1, 2005 at 12:29 AM | link
Susan F. Wood, Ph.D., Assistant
Commissioner for Women's Health and Director, Office of Women's Health, announced her resignation over the Plan B issue yesterday. In her resignation letter, she wrote: "I have spent the last 15 years working to ensure that science informs good health policy decisions. I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled."
- by Steve Latham on Sep 1, 2005 at 9:48 AM | link
I realize, of course, that the bit about the Christian Science Pharmacist (in another post) is meant to be humorous, but ...
I've been trying for a couple years, without notable success, to get people to recognize an ethically relevant connection between pharmacists refusing to dispense Plan B (as well as other sorts of birth control), and the unjustifiable requirement that one have a prescription in order to access such substances. This state of affairs needlessly pits the right of women to control their own reproduction against the moral convictions of some pharmacists. Making Plan B available OTC would moot the conscientious objections of these pharmacists (a good thing if you're a liberal) while enhancing women's autonomy (another good thing).
- by Bob Koepp on Sep 1, 2005 at 10:31 PM | link
I am beyond angry about this. Whether you agree with OTC Plan B or not and whether you agree with what happened in the Shiavo case or not, we should all be very afraid that scientific data is not driving decisions.
- by RK on Sep 2, 2005 at 2:33 AM | link