Plan B decision should precede confirmation
THE ISSUE
President Bush's nominee for FDA commissioner has been caught in a tangle over approval of a contraceptive drug.
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WOMEN in Hawaii, eight other states and 45 countries around the world have had access to a safe, effective nonprescription contraceptive for years.
Yet, nearly three years after its advisory committees recommended approval, the Food and Drug Administration has stalled action on the drug's over-the-counter sales, leading to criticism that the Bush administration was again putting ideology ahead of science in decision-making.
The delay has snagged acting FDA Commissioner Andrew von Eschenbach as he seeks to make his job permanent. His announcement -- on the day before a Senate hearing on his nomination -- that he would move ahead on the approval process appeared to be timed to defuse the issue.
Instead, it reminded key senators of an unfulfilled promise his predecessor had made to speed a decision on the drug, called Plan B. As a result, von Eschenbach's confirmation has been appropriately put on hold until the FDA takes action.
President Bush could bypass the Senate with a recess appointment of his longtime family friend, but that would do little to restore confidence in the agency, which has more than 100 whistle-blower cases pending before it and has been faulted for poor review of drugs it has sent to the marketplace.
Plan B has been approved for females of all ages as a prescription drug since 1999. It can prevent pregnancy if taken within 72 hours of sexual intercourse.
Under a law passed two years ago, females in Hawaii have been able to get the contraceptive without prescription from trained pharmacists. Federal approval would likely make Plan B more easily available in rural areas where fewer pharmacies carry the drug.
Reproductive conservatives and anti-abortion activists oppose Plan B, saying it would encourage riskier sex. Their fears have no basis; research has shown that the contraceptive's availability has no effect on sexual behavior.
Von Eschenbach wants the drug limited to women 18 and older but cited no data to support his position other than his belief that "18 is appropriate." Plan B's maker is willing to comply with that and other conditions, leaving no reason for the FDA to withhold approval.
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