FDA scientists plea for agency reform

FDA scientists have lobbed a bombshell into the debate over new leadership and reform at the agency after President-elect Obama takes office. According to a letter nine of them wrote to Obama's transition team, sweeping changes are necessary at the agency to banish a corrupt, anti-scientific culture.

The scientists say managers have demanded and intimidated FDA scientists to manipulate data, the Wall Street Journal reports, and honest employees can't act with integrity without fear of reprisal. "There is an atmosphere at the FDA in which the honest employee fears the dishonest employee," the letter states. The scientists say they've taken their concerns to Commissioner Andrew von Eschenbach and others, but no action was taken.

This plea to Obama's team comes after at least one similar missive from Congress: Rep. Bart Stupak wrote Obama requesting that he appoint an outsider to head up the FDA because, he said, the current management is too close to the industries they are charged with regulating. And the letter hits the news at a time when lawmakers are considering Tom Daschle's appointment as incoming chief of Health and Human Services, which oversees the FDA. During a hearing yesterday, Daschle said the agency has lost the confidence of the American people and of Congress. "This is unacceptable," he said.

- read the Wall Street Journal story
- see the post at WSJ Health Blog

Webinar

Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how IPM.ai transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.