Word: fda
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Dates: during 2000-2009
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...little wonder that Al Gore brought it up every chance he got, wouldn't let it go in his chat with Larry King last week, even as George W. Bush called the FDA ruling "wrong" and promised to build a "culture of life." The next President, Gore warns, could appoint as many as four Supreme Court Justices, enough to bury Roe v. Wade forever. Just in case any swing-voting women out there are taking abortion rights for granted, Gore noted that "I support a woman's right to choose; my opponent does...
Since 1988, when mifepristone was first approved in Europe, abortion-rights activists have fought to introduce it to the U.S. as the first alternative to surgical abortion. The FDA under President Bush banned its import in 1989, citing safety concerns. On his third day in office, President Clinton lifted the ban and ordered the FDA to begin safety testing. Developer Roussel Uclaf, meanwhile, sick of getting hammered by both sides, donated U.S. patent rights for mifepristone to the Population Council, a nonprofit reproductive-rights group founded 50 years ago by John D. Rockefeller. The council had to steer the drug...
Even advocates who had been hoping for this ruling for years were surprised at how few restrictions came with it. Though the agency had ruled mifepristone "safe and effective" back in 1996, it took four more years to find an acceptable manufacturer and figure out distribution. Last summer the FDA hinted that it was thinking of playing very tough: that only doctors who currently do surgical abortions would be allowed to prescribe mifepristone; that there might be some special certification required, or a rule that the doctor have access to an emergency room less than one hour away...
...time of the survey, the drug was still crawling through the approval process. Now that it has been cleared, the real test begins. A doctor's decision to offer the drug rests on a complex calculation. Many may read the FDA language about the pill's being limited to "physicians who can accurately determine the duration of a patient's pregnancy" to mean that they should do this with ultrasound--and most do not have ultrasound equipment in their office. Likewise, special training and extra malpractice insurance might dampen enthusiasm for offering the drug. Doctors will have the extra burden...
...risks associated with the drug, especially if it is misused or winds up circulating through an Internet black market. "It can be banned state by state or by Congress," says Michael Schwartz, administrative assistant to Representative Tom Coburn, a doctor from Oklahoma who last year tried to bar the FDA from spending federal funds to develop any kind of abortion drug. Schwartz thinks it is inevitable that the drug will be prescribed for women who are more than seven weeks pregnant, that there will be a lack of patient compliance and that someone will die from it. "These are predictable...