FDA should approve emergency contraceptive Plan B quickly to demonstrate its independence

EMBARGO: 00:01H (London time) Friday May 19, 2006. In North America the embargo lifts at 18:30H ET Thursday May 18, 2006.

Andrew von Eschenbach, acting US Food and Drug Administration (FDA) commissioner, should move quickly to approve emergency contraceptive Plan B to show he has the independence needed to head the organisation, states an editorial in this week's issue of The Lancet. von Eschenbach, former Director of the US National Cancer Institute (NCI), is President George W Bush's choice to lead the FDA. The Lancet believes he would bring considerable expertise and experience to the post. However, the FDA must be led by a commissioner willing to take independent stands, following the best judgment of his expert staff and scientific advisors, even when that means incurring the wrath of patient groups, industry, Congress, and the White House, states the editorial. For more than a year, the FDA has refused to issue a decision on an application to make Plan B available to women over age 16 without prescription, apparently to avoid offending anti-abortion supporters of President Bush, who claim that the contraceptive causes an abortion.

The Lancet comments: "Although supporters of Plan B's in the US Senate have blocked his confirmation until the FDA issues a ruling, as acting FDA commissioner von Eschenbach has refused to do so. His failure to issue a decision undermines both his credibility and that of the agency. von Eschenbach should move quickly to approve Plan B and show he has independence needed to be an effective leader of the FDA."

See also World Report on the FDA and Profile on Andrew von Eschenbach.


Contact: The Lancet press office T) 0207 424 4949/4249 [email protected]

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