Before President George W. Bush was even sworn into office, the newly appointed Secretary of Health and Human Services Tommy Thompson indicated that the FDA might review mifepristone’s approval.
When asked by Senator Hillary Rodham Clinton (D-NY) in his confirmation hearing whether he would “take any action to undo the FDA approval” of RU-486, Thompson stated: “I don’t intend to roll back anything unless it’s proven to be unsafe. Safety concerns are something that’s in question.” Immediately after the hearing, reporters asked Thompson to articulate his safety concerns. According to the New York Times, he replied, “I don’t know the specifics. People have told me there are some safety concerns. If there are, we want to review them.”
The FDA’s extremely rigorous approval of mifepristone was based on extensive scientific evidence demonstrating the drug’s safety and efficacy. Mifepristone is a safe, effective method of early abortion that has been used by millions of women worldwide. Mifepristone has been used in France since 1988, in the United Kingdom since 1991, in Sweden since 1992, and is now available in the European Union, Israel, Russia, Norway, China, Switzerland and increasingly throughout the rest of the world. The drug also is a possible treatment for uterine fibroid tumors, meningiomas, ovarian cancer and a myriad of other diseases and conditions that particularly affect women.
While the FDA cannot remove mifepristone from the market unless it is proven to be unsafe, the Feminist Majority Foundation has launched an emergency campaign to keep mifepristone on the market in anticipation of a myriad of anti-abortion strategies to attempt to restrict access to the medical breakthrough.
In addition to keeping the drug available as a a method of early abortion, the Foundation is working to immediately expand research on the drug’s cancer and other reproductive health indications now that U.S. supplies of the medication are available. Restrictions that imperil mifepristone’s availability as a method of early abortion could have a devastating effect on the drug’s availability for non-abortion research.
At Thompson’s confirmation hearing, Senator Barbara Mikulski (D-MD) also questioned whether the Administration’s summary dismissal of Food and Drug Administration Commissioner Jane Henney, under whose tenure mifepristone was approved, was tied to the mifepristone decision. Henney was given 24 hours to vacate her FDA office. When Clinton took office in 1993, he retained FDA Commissioner David Kessler in the position even though Kessler was an appointee of the elder President Bush.
Another threat to mifepristone comes from Congress. In February 2001, anti-abortion members of Congress introduced the so-called “RU-486 Patient Health and Safety Protection Act.” Co-sponsored by Senator Tim Hutchinson (R-Ark) and Representative David Vitter (R-LA), this legislation if passed would severely limit which doctors could prescribe the pill and would impose strict regulations on those doctors. Such restrictions and regulations, which would represent unprecedented Congressional interference with the practice of medicine, would severely limit access to mifepristone and impair its availability overall.
At a press conference of pro-choice leaders in Congress and abortion rights organizations, Feminist Majority Foundation President Eleanor Smeal said, “What Republicans are doing by introducing legislation to restrict mifepristone is increasing the size of the gender gap in the 2002 elections.” Smeal continued, “Congress should be calling for increased funds to research the drug’s cancer fighting properties rather than fighting this constant battle to limit women’s reproductive health care options.”