POSTED 19 OCTOBER 2006
Plan A for Plan B
Those who charge that the Bush Administration ignores or skewers science in its decisions frequently point to how the Food and Drug Administration handled the emergency contraceptive "Plan B." This after-sex birth control pill was approved for prescription sale in 1999. In 2003, the drug's manufacturer applied to sell Plan B over-the-counter (OTC; without a prescription) to women aged 16 and up.
Photo: Barr Pharmaceuticals
Plan B is a "morning after" pill that prevents ovulation, and therefore pregnancy. It does not affect a fertilized egg or cause abortion. The drug must be taken quickly, said a press release from Sharon Camp, president and CEO of the Guttmacher Institute, a non-profit group on reproduction and sexual health. "Emergency contraception is seven times more effective if it is used within the first 24 hours. It won't work at all once a woman is pregnant. So it's critical that women can get it very quickly, even on weekends and holidays."
While opponents worried that Plan B could promote immorality and promiscuity, emergency contraception explains up to 43 percent of the decline in U.S. abortions from 1994 to 2000, according to Guttmacher.
OTC sales were a good idea, says Susan Wood, former assistant FDA commissioner for women's health who is a research professor at the George Washington University School of Public Health and Health Services, and they got support from FDA staff and outside groups. "You had the AMA [American Medical Association], the American College of Obstetrics and Gynecology, and the American Academy of Pediatrics all saying, quite strongly, that there is no need to have a prescription, and it is in the best interest of patients to have direct [and fast] access to emergency contraception."
But the application foundered at the top of the FDA, she says. "It went through two full rounds of approval... and each was delayed significantly." In 2005, FDA commissioner Lester Crawford issued an approval for ages 17 and up, but also called for what Wood describes as "a full blown federal regulation process" which amounted to dumping the application into a black hole. "What was so controversial about this contraceptive being available to essentially adult women? There was a huge consensus on safety, and on the appropriateness of going over-the-counter."
At that point, Wood resigned in protest. "I knew instantly that this was not credible, was not something I could explain or defend to people outside the FDA, which was part of my job. It was an unacceptable action."
Soon afterward, Crawford abruptly quit (without explanation), after only two months in the FDA director's chair. The explanation finally surfaced this week: on Oct. 17, 2006, newspapers reported that Crawford, now a lobbyist, is about to plead guilty to two conflict-of-interest crimes. Federal prosecutors have charged that this public servant owned shares of several companies that the agency he directed was supposed to regulate (see "Former F.D.A. Chief Is Charged ..." in the bibliography).
Plan B for Plan B
The Administration suddenly found a new approach toward Plan B last summer, as Andrew von Eschenbach sought confirmation to follow in Crawford's illustrious footsteps as FDA commissioner. Democratic senators Hillary Clinton and Patty Murray had put "holds" on the nomination, unless von Eschenbach would promise to OK Plan B OTC ASAP. "On July 31, 2006," Wood says, "he announced, lo and behold, that they do not need a rulemaking and federal regulation. von Eschenbach had been saying that this was a complex regulatory issue ... and he held on to that line until the day before his confirmation hearing."
Wood says the episode shows that the agency needs to get back to basics. "This is not how we want our health agency to make decisions. We want them based on medical evidence, and on what is best for the public health."
Photo: Michael Forster Rothbart Courtesy UW-Madison
Plan B will be sold without prescription by the end of the year, but only to women aged 18 and up. Younger women will still need a prescription, and everybody will have to ask -- these "over-the-counter" pills will actually be stored behind-the-counter.
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Megan Anderson, project assistant; Terry Devitt, editor; S.V. Medaris, designer/illustrator; David Tenenbaum, feature writer; Amy Toburen, content development executive