Saturday, May 08, 2004

Morning-After-Pill Ruling Defies Norm


A top federal drug official said yesterday that he rejected not only the judgment of an advisory panel but also the recommendations of his own staff when he refused to allow a morning-after pill to be sold over the counter.

Dr. Steven Galson, acting director of the Food and Drug Administration's center for drug evaluation and research since October, acknowledged in an interview that his action was not the norm.

The agency's decision to take into account how some people might change their behavior because a drug is more available is also unprecedented, critics charge. Dr. Scott Spear of the Planned Parenthood Federation of America, noted that the agency was unlikely to ask the makers of anticholesterol pills if people would eat more cheeseburgers when their drugs became available over the counter.

"It's a bogus issue," Dr. Spear said. "They should be asking if the drug is safe and whether it's effective. That's it."

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