FDA rightists attack Plan B contraception

In an insidious attack on women’s rights, top Food and Drug Administration officials have set back women’s reproductive rights by stopping widespread access to emergency contraception (EC), known as Plan B, without waiting to consider a scientific evaluation of the medication.

Available now only by prescription, Plan B is an emergency contraceptive known popularly as the “morning-after pill.” Made up of two potent birth control pills, it prevents ovulation and fertilization; it is considered a safe and effective method of backup birth control.

Public health officials worldwide support Plan B as a safe, effective back-up contraceptive. “The drug is available without a prescription in 33 countries...Its switch to nonprescription status in the U.S. was endorsed by 70 scientific organizations, including the American Medical Association and others,” wrote the Union of Concerned Scientists (UCS) in July 2004.

The sooner Plan B is taken after unprotected sexual intercourse, the more effective it is—thus the need for immediate over-the-counter availability. This EC medication could help prevent unintended pregnancies and make many abortions unnecessary.

GAO says FDA ‘plays politics’

A Government Accountability Office study issued Nov. 14 confirmed the suspicions of many women’s groups and health-care providers—that top FDA officials—political appointees, and not scientists or doctors—decided to prevent millions of women from having over-the-counter access to emergency birth control.

The GAO report said the involvement of top agency officials in the Plan B decision was “very rare,” and that ignoring its own advisory committee and staff scientists was “unprecedented.” A Planned Parenthood Federation spokesperson said that the GAO report showed that the FDA “had been playing politics with women’s health all along.”

Originally, in December 2003, a scientific advisory committee voted 23-4 to approve nonprescription Plan B. The NYTimes reports that subsequently Dr. Janet Woodcock, FDA acting deputy commissioner of operations, and Dr. Steven Galson, acting director of the FDA’s Center for Drug Evaluation and Research, told staff members that although the agency’s scientific review of the application wasn’t finished, nonprescription Plan B would be turned down.

Galson overruled the committee’s vote and ignored the recommendations of FDA’s staff medical experts and scientists, and most health-care organizations, including the American College of Obstetricians and Gynecologists. Galson decided that Plan B was “not approvable” for over-the-counter use but gave no scientific evidence for this ruling, made in May 2004.

FDA internal memoranda revealed that three levels of staff reviewers disagreed with Galson’s decision. (Washington Post, June 18, 2004)

Although FDA advisory committees looked at and okayed 23 other applications for over-the-counter drugs from 1994-2004, the only one the agency denied was that for Plan B.

The Nov. 15 New York Times reported that the FDA’s rejec tion of the application for nonprescription Plan B in May 2004 came months before a scientific review was finished.

Galson’s actions were “nearly unprecedented,” wrote the UCS. They explained, “By law, FDA is required to approve drugs that are found to be safe and effective” and that “former FDA officials said they couldn’t remember a time when an FDA official had overridden its own staff and advisory committees.”

Dr. Susan Wood resigned in August as Director of the FDA Office of Women’s Health after the third agency delay on Plan B. Wood’s response to the GAO report, according to the Times, was that “the FDA’s willingness to ignore science in the service of abortion politics has ‘only gotten worse’ since the events that were the focus of the GAO investigation.”

When Wood resigned, she criticized the FDA for limiting “women’s access to a product that would reduce unintended pregnancies and reduce abortions” and added that “scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled.”

Since there is no scientific basis to deny use of Plan B and it is safe, effective and meets FDA criteria for nonprescription use, the agency’s “decision proves [that] dangerous anti-choice ideology is trumping scientific fact at the expense of women’s health and well-being,” stresses Dr. Vanessa Cullins, Planned Parenthood Federation vice president for medical affairs.

FDA ‘a tool of the White House’

James Trussell, an FDA advisory panel member, said that to overrule the December 2003 decision and deny over-the-counter status, officials invented reasons that are scientifically “complete and utter nonsense.” He said the FDA was acting “as a tool of the White House,” with politicians making medical decisions. (UCS)

The collusion of the Bush administration and its agencies’ officials in promoting the ultraright’s agenda is clear. This move is a frontal attack on healthcare and reproductive rights for women where scientific and medical knowledge are thrown aside for reactionary political and ideological reasons.

Preven, another EC drug, and Plan B have been prescribed and used successfully since 1998 and 1999, respectively, by millions of women in the U.S. The Center for Reproductive Rights unsuccessfully tried to expand EC’s availability as early as 2001, when it asked the FDA to give nonprescription approval.

Emergency contraception has been the target of a heavy reactionary attack for years from anti-choice groups such as American Life League and Stop Planned Parenthood International. Deliberately mischaracterizing it as an “abortifacient,” (abortion-causing) drug, and spreading other disinformation and distortions about it, they have set about trying to prevent its use—whether or not it is prescribed.

Rightwing claims about Plan B fly in the face of reality. Even the FDA in its scientific documents considers it a contraceptive and says it cannot terminate a pregnancy.

The rightwing is waging a deliberate campaign to deny women this key contraceptive method, as part of their overall move to roll back all of women’s reproductive rights.

This has already had very serious consequences for women. Some pharmacists have refused to fill EC prescriptions. Many drugstores don’t carry it. In 1999, Wal-Mart refused to sell Preven EC in its 2,400 pharmacies. A Den ton, Texas, pharmacist in February 2004 refused to fill a rape
survivor’s EC prescription, citing “religious convictions.”

While the reactionaries carry out a vehement campaign to overturn Roe v. Wade and abortion rights, their fuller agenda becomes clearer. This shows how vigilantly women, their organizations, healthcare and medical providers and all progressive forces must be in defending the right to all reproductive rights.