FDA Scientists To Obama: Agency Is ‘Fundamentally Broken’

fda-logo.jpgNine Food And Drug Administration (FDA) scientists have sent a letter to President-elect Barack Obama’s transition team, urging the incoming administration to reform the “fundamentally broken” agency. The letter’s authors revealed that President Bush’s FDA managers “ordered, intimidated and coerced scientists to manipulate their research results in violation of federal law.” Scientists who did not comply with managers faced “the threat of disciplinary action”:

The scientists wrote that they have raised their concerns with FDA Commissioner Andrew von Eschenbach and Bill McConagha, an attorney and the assistant commissioner for accountability and integrity at the agency, but added that the agency has taken no action to address the issues. In addition, they wrote that FDA has promoted and rewarded some of the managers involved with the inappropriate practices.

Indeed, in 2005, a Government Accountability Report (GAO) concluded 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 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,” the report concluded.

Political interference led Susan F. Wood, the top Food and Drug Administration official in charge of women’s health issues, and Frank Davidoff, an FDA consultant to an advisory panel that voted to approve Plan B, to resign in protest. “I can no longer serve … when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled,” Wood explained.

Earlier today, during his confirmation hearings, Health and Human Services nominee Sen. Tom Daschle (D-SD) emphasized, “as Secretary, I will work to ensure that trust in FDA is restored as the leading science based regulatory agency in the world.” “I will send a clear message from the top that the President and I expect key decisions at the FDA to be made on the basis of science – period,” Daschle said.