Nine FDA Scientists Ask Obama Transition Team To Implement Reforms At Agency

Main Category: Regulatory Affairs / Drug Approvals
Article Date: 09 Jan 2009 - 3:00 PDT

email to a friend   printer friendly   opinions  

FDA is "fundamentally broken" and requires reforms, according to a letter sent to the transition team of President-elect Barack Obama by nine agency scientists, Dow Jones reports. The scientists sent the letter to John Podesta, head of the transition team, as well as former Senate Majority Leader and HHS Secretary-designate Tom Daschle (D-S.D.); Baltimore Health Commissioner Joshua Sharfstein, who has led a team assembled by Obama to assess FDA; Senate Health, Education, Labor and Pensions Committee Chair Edward Kennedy (D-Mass.); and eight other lawmakers.

According to the letter, FDA managers have ordered, intimidated and coerced scientists to manipulate their research results in violation of federal law, and scientists who do not comply with managers face the threat of disciplinary action. The letter states, "There is an atmosphere at FDA in which the honest employee fears the dishonest employee." The scientists also criticized the FDA review process for medical devices as "corrupted and distorted by current FDA managers, thereby placing the American people at risk."

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.

The scientists hope that the letter will prompt Daschle to implement comprehensive reforms at FDA. The Obama transition team declined to comment in the letter. FDA spokesperson Judy Leon said that the agency has worked "very closely" with the Obama transition team and plans to address any concerns raised by the team, adding that FDA is "actively engaged in a process to explore the staff members' concerns and take appropriate action" (Mundy/Favole, Dow Jones, 1/7).

House Committee Investigates $1.5 Million FDA Contract
In other FDA news, House Energy and Commerce Committee Republicans have launched an investigation into a $1.5 million contract that the agency awarded to a consulting firm in California, the Wall Street Journal reports. The contract, awarded to the Center for Professional Development, included an agreement to organize a management conference to address efforts to improve morale among the almost 500 employees at the agency's Center for Drug Evaluation and Research. FDA awarded the contract in 2007 to "improve workplace leadership" and "empower staff" after the Institute of Medicine released a report that found that CDER in some cases had ignored concerns raised by scientists about medication safety.

The lawmakers raised concerns that FDA decided to spend funds on the contract at a time when staff shortages have resulted in delays on decisions on applications for new medications. Rep. John Shimkus (R-Ill.) said, "To remove managers for two days to discuss this morale problem, instead of putting food and drug safety first, is ridiculous." In addition, FDA should not have awarded the contract to a consulting firm that "lists numerous pharmaceutical companies as clients -- at a time when those same ties are being questioned within FDA," Shimkus said. The Center for Professional Development lists as current and former clients 10 major pharmaceutical companies, such as Bristol-Myers Squibb, GlaxoSmithKline, Novartis, Merck, and Pfizer (Mundy, Wall Street Journal, 1/8).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.

© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

• Additional
• References
• Citations