Bush Administration Could Reverse Mifepristone Approval

Because mifepristone, the so-called "abortion drug," was approved under the FDA's "fast-track" approval rules, Bush administration officials "will find that the drug can be pulled more easily than most medications," should they wish to revoke it, the Washington Post reports. Drugs in the fast-track protocol are usually for "life-threatening diseases," such as AIDS, and are sometimes allowed on the market "after less testing than other medications." Because of this, the fast-track rules give the FDA "special authority" to restrict how the drug is distributed and "specify a procedure for removing it quickly from the market should problems arise." An FDA official said the agency used the protocol for mifepristone in order to have more "control over how it is prescribed," not to make recall easier. Abortion rights advocates, however, are "concerned" about the fast-track protocol's implications under the new administration. Newly-approved HHS Secretary Tommy Thompson said during his confirmation hearings that he "intended to look into the safety of mifepristone," and White House Chief of Staff Andrew Card said last week that the administration is reviewing the FDA's approval of the drug. Antiabortion advocates argue that mifepristone and misoprostol, taken in conjunction to induce a medical abortion, pose "serious health risks" such as uterine rupture. Supporters of the drug, however, point out that mifepristone has an "extensive international track record," having been used by millions of women in 17 other countries. One hundred U.S. clinics are currently offering medical abortions according to the National Abortion Federation. Doctors prescribing mifepristone must report any "serious complications" to manufacturer Danco, who in turn must report them to the FDA. A company spokesperson said that so far, "We've experienced no serious or unexpected adverse events," and added that the drug was "thoroughly reviewed" before FDA approval was granted. The FDA could seek to take the drug off the market "if evidence emerged that it was dangerous or if the system for providing the drug and monitoring its use wasn't working," according to the Post. The FDA commissioner would conduct a hearing and make a decision, which could then be appealed in federal court. American Life League President Judie Brown said that her organization has asked for a congressional oversight hearing, but that so far all she has heard from congressional leaders is "We're waiting to see what the White House does" (Okie, Washington Post, 1/28).