In a November 29 report for FOX News Channel's Special Report with Brit Hume on the abortion drug mifepristone, commonly known as RU-486, general assignment correspondent Major Garrett failed to correct Senator Sam Brownback's (R-KS) misleading claim that the U.S. Food and Drug Administration (FDA) had followed an expedited process to approve the drug. In fact, the FDA approved mifepristone fully four years after its sponsor filed an application -- eight times longer than the average FDA approval process for new drugs -- and twelve years after France declared the drug safe.
Garrett's story focused on efforts by members of Congress who oppose abortion to ban the drug in the wake of the FDA's decision on November 15 to add additional warning language to the drug's label following the death of a California woman who took the drug to terminate a pregnancy. Garrett showed a clip of Brownback suggesting that the FDA had cut corners during the approval process and cast the debate over the drug's safety as a case of he said-she said without verifying the competing assertions.
From the November 29 edition of Special Report with Brit Hume:
GARRETT: Kansas Republican Senator Sam Brownback accused the FDA of rushing the approval process for RU-486. He's introduced legislation to pull the drug and review its safety.
BROWNBACK [video clip]: It went through this expedited process that's meant only for drugs that are life-saving drugs.
GARRETT: Pro-choice advocates say RU-486 is a safe, effective alternative to surgical abortion. Elizabeth Cavendish of NARAL/Pro-Choice America also says complications resulting in death have been few and not conclusively linked to the drug.
In fact, the approval process for mifepristone was unusually lengthy. The New York-based nonprofit group Population Council first filed for FDA approval for the drug in 1996; the FDA approved the drug in 2000. According to an Associated Press report, “The FDA in 1996 declared mifepristone a safe and effective early abortion method, but delayed full approval because Danco [Laboratories, which Population Council set up to distribute the drug in the United States] had problems satisfying manufacturing and other final requirements.” FDA's website states that “the average review time for an innovative new drug is now only 6 months, and some have been approved even faster.” This extended process for mifepristone occurred even though, as the FDA has noted, the drug “was first approved for use in France in 1988. Since then, more than 620,000 European women have taken mifepristone.” The AP reported that according to Danco, 360,000 American women have taken the drug since 2000. The recent death is the third allegedly associated with mifepristone.
Dr. Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, expressed confidence that the drug is safe. “We feel that the safety profile of this drug, along with the steps that we're taking ... are adequate to allow the drug to be used safely,” Galson said, according to the AP article.
The AP reported on September 29, 2000, that “RU-486 is authorized in 12 of the 15 European Union countries, with the exception of Ireland, Portugal and Italy." (The EU has since expanded to 25 countries; Cyprus, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Slovakia, and Slovenia were not members in 2000.)