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Editorial: FDA's wonderland / On Plan B, it's a place where politics trumps fact
Friday, November 18, 2005

The U.S. Food and Drug Administration needs a name for the outrageous mind-set used to decide whether Plan B, the emergency contraceptive drug, could be sold without a prescription.

In our humble opinion, the FDA should call it the Queen of Hearts Rule. You know, from Alice in Wonderland, where the Queen declared, "Sentence first -- verdict afterward."

The Government Accountability Office documented the FDA's trip to wonderland in a report on the decision this year to reject nonprescription sales of the morning-after pill.

The FDA has procedures for deciding whether prescription drugs like Plan B can be switched to nonprescription status, and they are much like a trial. Manufacturers submit scientific evidence on safety and other matters. The FDA's scientific staff and expert advisory panels weigh the evidence.

With the jury still out and months more work needed to reach a scientific conclusion, top FDA officials invoked the Queen of Hearts Rule. Officials told staff scientists they already had decided to keep Plan B prescription-only. FDA officials later rejected the scientific verdict -- that Plan B should become a nonprescription drug.

The GAO's findings support the view that the FDA allowed politics to trump science. Conservatives had lobbied President Bush to intervene and block nonprescription sales of the drug.

Mark B. McClellan, then FDA commissioner, apparently made the decision. Mr. McClellan refused to cooperate in the investigation, and the GAO left many questions begging for answers. They include the White House's role and whether destruction of Mr. McClellan's memos on Plan B violated federal record-keeping laws.

The FDA's inspector general and Congress have power to get answers, and they should pick up the investigation where the GAO left off.

Mr. McClellan's role should get attention, partly because he now heads a powerful and far-reaching arm of the government: the Centers for Medicare and Medicaid Services, which runs Medicare and Medicaid. Mr. McClellan holds 20 percent of the federal budget in his hands and oversees $519 billion spent annually on health care for 83 million people.

With a track record at FDA of apparently bending to political influence, and a Queen of Hearts mind-set, Mr. McClellan has invited a review of his performance.

First published on November 18, 2005 at 12:00 am