THE U.S. Food and Drug Administration needs a name for the outrageous regulatory mindset used to decide whether Plan B, the emergency contraceptive drug, could be sold without a prescription. In our humble opinion, 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 (GAO) documented FDA's trip to wonderland in a report on the decision to reject non-prescription sales of the morning-after pill.
FDA has procedures for deciding whether prescription drugs like Plan B can be switched to nonprescription status. They are much like a trial. Manufacturers submit scientific evidence on safety and other matters. 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 non-prescription drug.
GAO's findings support the view that 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. GAO left many questions begging for answers. They include the White House's role and whether destruction of Mr. McClellan's memos and emails on Plan B violated federal record-keeping laws.The FDA's inspector general and the U. S. Congress have power to get answers, and they should pick up the investigation where GAO left off.
Mr. McClellan's role should get attention, partly because he now heads the Centers for Medicare and Medicaid Services, the agency that runs the Medicare and Medicaid programs. 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 mindset, Mr. McClellan has invited a review of his performance at CMS.
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