Press Release - One Year Later: Hinchey, Colleagues Demand Answers From Inspector General Investigating Former FDA Chief's Sudden Resignation

Date: Sept. 21, 2006
Location: Washington, DC
Issues: Drugs

One Year Later: Hinchey, Colleagues Demand Answers From Inspector General Investigating Former FDA Chief's Sudden Resignation

Washington, D.C. - On the eve of the one year anniversary of former Food and Drug Administration (FDA) Commissioner Lester Crawford's sudden resignation, Congressman Maurice Hinchey (D-NY) and four of his House colleagues called on U.S. Department of Health and Human Services (HHS) Inspector General Daniel R. Levinson to update them on his investigation into the circumstances behind Crawford's departure. On September 29, 2005, just six days after Crawford resigned, Hinchey and his same four colleagues requested that Levinson conduct a probe into the matter with a particular focus on whether the former FDA head had any financial conflicts of interest. While Levinson responded to inform the House members that he was conducting an investigation, he has not yet reported any findings.

"We are deeply troubled by the length of time it has taken your office to come to a definitive conclusion on this important matter," Hinchey and his colleagues wrote to Levinson. "As the nation continues to await the appointment of the FDA's next permanent commissioner, we are very concerned that the absence of a report from your office on the circumstances surrounding Dr. Crawford's sudden resignation will only perpetuate financial and other conflicts of interest at the agency. Therefore, we respectfully request an update on the status of your investigation, including an estimate on when the public can expect to learn the results of your work."

Crawford unexpectedly resigned as FDA Commissioner on September 23, 2005, but gave no specific reason for his decision. HHS has declined to give an explanation of Crawford's resignation, saying that it was a personnel matter. Various news reports have suggested that Crawford stepped aside because of conflicts of interest that may have included unreported drug company stockholdings. The FDA remains without a permanent commissioner.

In their letter to Levinson, the House members expressed their hope that the Inspector General would provide them with an update on his investigation and warned of potential budgetary implications if he failed to keep them posted.

Hinchey is the author of the Food and Drug Administration Improvement Act (FDAIA) of 2005, a sweeping reform bill that would end the financial link and inappropriately close relationship between the drug industry and the FDA, eliminate conflicts of interest on FDA advisory committees, and vastly improve the agency's post-market drug safety operations. The House approved the conflicts of interest component of the FDAIA as an amendment to the Agriculture, Rural Development, FDA, and Related Agencies Appropriations bill for Fiscal Year 2007. The measure still needs to go before a conference committee of House and Senate leaders.

Joining Hinchey in signing the letter were: Congressman Sam Farr (D-CA), Congresswoman Lynn Woolsey (D-CA), Congresswoman Marcy Kaptur (D-OH), and Congressman Raúl Grijalva (D-AZ).

The text of the letter from Hinchey and his colleagues to Levinson follows:

September 21, 2006

The Honorable Daniel R. Levinson
Office of the Inspector General
Office of Public Affairs
U.S. Department of Health and Human Services
Room 5541 Cohen Building
330 Independence Avenue SW
Washington, DC 20201

Dear Inspector General Levinson:

One full year after Dr. Lester Crawford left his post as Commissioner of the Food and Drug Administration, a number of questions remain unanswered regarding the circumstances of his abrupt departure. We are deeply troubled by the length of time it has taken your office to come to a definitive conclusion on this important matter.

Over the past year, we have seen the release of surveys demonstrating a lack of confidence in the FDA, with both agency employees and the American public indicating a loss of faith in an agency that has long been a trusted protector of consumer safety. As the nation continues to await the appointment of the FDA's next permanent commissioner, we are very concerned that the absence of a report from your office on the circumstances surrounding Dr. Crawford's sudden resignation will only perpetuate financial and other conflicts of interest at the agency. Therefore, we respectfully request an update on the status of your investigation, including an estimate on when the public can expect to learn the results of your work.

We enclose a copy of the original correspondence regarding this matter that we sent to you on September 29, 2005. We expect to be kept informed of any progress, and we certainly hope this matter can be brought to closure so that the lack of a comprehensive response will not be an issue at FDA's FY 2008 appropriation hearing. Thank you for your consideration of our request. We look forward to your reply.
Sincerely,

Maurice Hinchey, Sam Farr, Lynn Woolsey, Marcy Kaptur, Raúl Grijalva


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