New GAO Report Confirms Politics Trumped Science in FDA Decision on "Plan B"
NEW YORK, NY - Today, Representatives Carolyn Maloney and Joseph Crowley, with leaders of the National Organization for Women, the Center for Reproductive Rights, NARAL Pro-Choice New York and Planned Parenthood, revealed a new Government Accountability Office (GAO) report finding that political pressure led to the Food and Drug Administration’s 2004 decision to deny over-the-counter (OTC) status to Plan B, an emergency contraceptive.
The GAO launched its investigation in September 2004, at the request of 48 members of Congress, including Reps. Maloney and Crowley. The report's findings included the following:
- Political Appointees, Not Scientists, Denied Application: Dr. Stephen Galson, who in 2004 was the FDA’s Acting Director of Drug Evaluation and Research, told multiple FDA officials that Plan B’s application would be denied, even though FDA scientists had yet to complete their review of the drug. The GAO report cites the official minutes of a January 2004 meeting in which Dr. Galson told FDA scientists -before their review was complete- that the Office of the Commissioner was recommending denial for Plan B.
- Scientific Experts Overruled: The FDA Commissioner’s denial overruled the FDA’s expert advisory panel, FDA scientists in charge of over-the-counter and reproductive drugs, and the director of the Office of New Drugs, all of whom recommended approving Plan B for OTC use.
- GAO Investigation Obstructed: Dr. Mark McClellan, then the FDA Commissioner, refused to cooperate with the GAO’s investigation. Further, the FDA did not provide the GAO with copies of any communications to or from the Commissioner’s office regarding Plan B. Instead, the FDA claimed, in an apparent violation of federal records law, that it routinely deleted all of the Commissioner’s correspondence, including e-mails and memos.
“At the FDA, politics infected what should have been a medical decision," said Congresswoman Maloney. "The new GAO report shows clearly why our bill, The Plan B for Plan B Act, is so necessary. When politics trump science, what you get is bad medicine.”
“The White House won't even say if the President supports birth control in general," Maloney added. "Clearly, the Administration's ‘Plan A’ is to always appease the right wing.”
“The GAO report released today confirms what we have all known for some time,” said Congressman Crowley. Under Commissioner Lester Crawford the FDA lost sight of its Congressional mandate, to evaluate the efficacy and safety of drugs being brought to market. When its own internal review board stated the safety of Plan B for over the counter sale, the FDA continued to bow to right-wing pressure by dragging its feet in approving the sale to help prevent unintended pregnancies. Under Commissioner Crawford, who resigned in a cloud of controversy, the FDA was used as a political tool, and not a policy making institution. The people who have suffered the most are the women who have not had access to a safe and effective form of emergency contraception as a result.”
"As the largest provider of EC in the country, Planned Parenthood knows firsthand the importance of women having access to this safe, effective method of backup birth control,” said Dana Czuczka, Director of Government Relations for Planned Parenthood of New York. “We strongly believe that every woman at risk of unintended pregnancy should have immediate access to EC - without prescription, without hassle and without delay."
A full copy of the GAO report can be found at:
Plan B is a concentrated dosage of birth control pills that, if taken within 72 hours of contraceptive failure or unprotected sex, can reduce a woman' risk of pregnancy by up to 89 percent.
Following the FDA’s 2004 denial, Plan B’s manufacturer submitted additional information about the drug to the FDA, which agreed to conduct another review of Plan B’s suitability for OTC use. However, the FDA recently stated that the agency is indefinitely postponing its decision. In response, a bipartisan group of legislators recently introduced legislation, The Plan B for Plan B Act of 2005, that requires the FDA to immediately issue a decision on Plan B’s application. The bipartisan bill was introduced by Representatives Maloney, Crowley, Christopher Shays (R-CT) and Jay Inslee (D-WA), all members of the Congressional Pro-Choice Caucus.
The legislation states that failure to make a decision would result in automatic approval of OTC status. If the FDA determines the approval shouldn't stand they can act to deny the application -- but they would have to finally act.
The full text of the bill can be found at: