Morning After at the FDA

By Viveca Novak, KAREN TUMULTY

Is 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 and recommended for approval by the professional staff here, has been overruled." Wood was highly respected by others at the agency, and her concerns are shared by many. Says a colleague, "She just couldn't take it anymore."

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 restrictive rule, with no age limits. "There wasn't any back and forth" leading up to Crawford's announcement, an FDA official says. "The career staff simply wasn't involved in the decision. It was a political decision."

Opponents of the pill, who say they consider its effects indistinguishable from abortion, make no apologies about treating it as a political issue. Two days before 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