Word: fda
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Dates: during 2000-2009
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...surprising answer is no. Sure, the FDA is supposed to make sure that new drugs are safe and effective and that promotional claims about them don't get out of hand, but the agency defines efficacy as outperforming a sugar pill. "You do not have to show one drug is better than another," explains Dr. Robert Temple, who heads the FDA's office of medical policy. (The exception: new drugs are tested against older therapies in devastating ailments like cancer or AIDS, when it would be unethical to give a control group placebos.) While Temple plainly sees the value...
...politics keeping the long-delayed emergency contraceptive known as the morning- after pill, or Plan B, off the over-the-counter market? Advocates of making the drug more easily available were infuriated when U.S. Food and Drug Administration (FDA) Commissioner Lester Crawford announced on Aug. 26 that he was delaying a decision on the pill yet again to allow time for additional study and public comment. Assistant commissioner Susan Wood, who heads the FDA'S Office of Women's Health, last week resigned in protest, saying she could "no longer serve as staff when scientific and clinical evidence, fully evaluated...
Crawford's move was unusual in contradicting the advice of scientists at his own agency. In a 12-page internal memo obtained by TIME, Dr. Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, urged that Barr Laboratories, which makes the drug, be allowed to sell the pill over the counter, albeit with age restrictions. In the memo, written on Aug. 26, Galson argued that Plan B had been proved "safe and effective without the supervision of a practitioner licensed by law for women ages 17 and older." Subordinates had argued for an even less...
...Crawford's announcement, a group headed by conservative activist Paul Weyrich forwarded an e-mail to like-minded advocates, asking them to "call the White House comment line as soon as possible to say 'No Plan B!'" Why were the calls directed to the White House and not the FDA? "I'm told they take notes on the calls," says Paul Caprio, author of the e-mail, "and that information gets to the President as well as all the top White House staff members." --By Viveca Novak and Karen Tumulty
...HOPE FOR INSOMNIACS The sleepless will soon have a new weapon to use in their nightly battle against insomnia. The drug, available next month under the brand name Rozerem, is related to the hormone melatonin, and will be the first FDA-approved prescription sleep aid not listed as a controlled substance...