FDA must testify about Plan B lag

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FDA must testify about Plan B lag

By Kathleen Kerr, February 28, 2006

Senior Food and Drug Administration officials must testify about the federal agency's failure to decide whether a controversial emergency contraceptive pill may be sold without a prescription, a federal judge in Brooklyn ruled late Friday.

The decision by Magistrate Viktor Pohorelsky came in response to FDA legal efforts to keep secret the agency's discussions and correspondence about the pill, called Plan B. Barr Pharmaceuticals of upstate Pomona makes Plan B. Barr bought the rights to the drug from Women's Capital Corp., which in 2003 applied for approval to sell it over the counter. Barr pursued the application. Two advocacy groups and nine women from a group called the Morning-After Pill Conspiracy sued the FDA in January 2005, alleging it ignored a statutory deadline for deciding whether Plan B could be sold without prescription. In December, the FDA lost a motion seeking to have the lawsuit dismissed.

Questioning the FDA's intentions, Pohorelsky said in his order: "Thus, inquiry about contacts between those outside the agency and those within the agency is appropriate to expose whether improper influences led to the FDA's actions."

Conservative and anti-abortion groups have lobbied the Bush administration to prevent nonprescription Plan B sales.

Last August, Susan Wood, the FDA's top women's health official, resigned over the FDA's failure to act on Plan B. And in October, Dr. Frank Davidoff, a member of the FDA's Nonprescription Drugs Advisory Committee, also resigned, saying the agency was heeding politics but ignoring science.

Pohorelsky and U.S. District Judge Edward Korman, who has refused to dismiss the lawsuit, have said in separate rulings the FDA appears to be conducting a "filibuster" to avoid making a decision that could be subject to judicial review.

Barr says Plan B can prevent pregnancy if taken within 72 hours after intercourse and does not cause abortions. A spokeswoman for Barr, which is not a party to the lawsuit, had no comment yesterday.

Annie Tummino, a plaintiff, said yesterday that "these high-ranking FDA officials are finally going to have to answer to women and our concerns."

And Nan Strauss, staff attorney for the Manhattan-based Center for Reproductive Rights, also a party to the lawsuit, said: "We're very pleased that the court has recognized that there is a strong showing of bad faith."

At the FDA, spokeswoman Susan Cruzan said, "We will carefully review it and decide what the next steps are."

Strauss said the legal team handling the lawsuit has already contacted the FDA to schedule depositions.

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