SENATORS CALL FOR RELEASE OF PLAN B APPROVAL PROCESS FINDINGS
Twelve Democratic senators and one Independent have asked the Government Accountability Office (GAO) to release the findings of its ongoing probe into the FDA's approval process for Barr Pharmaceuticals' Plan B emergency contraceptive.
In a recent letter to GAO Comptroller General David Walker, the senators urged a speedy completion of the report, which Congress requested last summer. The letter follows the FDA's recent announcement that it was delaying a decision on the OTC status of Plan B (levonorgestrel), while at the same time concluding the data shows the drug could be safely used without a prescription by women 17 years and older.
The senators said the FDA's decision "leaves the strong impression that concerns about politics have overridden concerns about public health in this process."
"Yours is the only independent investigation underway on this important matter of women's health, and it has the potential to shed much-needed light on the FDA's actions," states the letter to the GAO. The letter was signed by Sens. Hillary Rodham Clinton (D-N.Y.), Patty Murray (D-Wash.), Edward Kennedy (D-Mass.), Maria Cantwell (D-Wash.), Barbara Boxer (D-Calif.), Jon Corzine (D-N.J.), James Jeffords (I-Vt.), Christopher Dodd (D-Conn.), Daniel Inouye (D-Hawaii), Debbie Stabenow (D-Mich.), Tom Harkin (D-Iowa), Mark Dayton (D-Minn.) and Charles Schumer (D-N.Y.).
Clinton called for the GAO investigation in June 2004 after the FDA initially denied OTC status for Plan B despite an advisory committee's overwhelmingly positive recommendation. The FDA has since been battered by accusations the agency is motivated by politics and ideology rather than science -- a charge that top officials have denied.
But at least one FDA official recently gave credence to that position. Susan Wood, director of the FDA's Office of Women's Health, resigned from the agency in late August, citing concerns that the FDA overruled scientific and clinical evidence in refusing to approve OTC Plan B.