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Letter to Commissioner of the Food and Drug Administration Andrew C. von Eschenbach, M.D.


Location: Washington, DC


This morning, Senator Edward Kennedy, Majority Leader Harry Reid, Speaker Nancy Pelosi and Congressman John Dingell, sent the following letter to Andrew C. von Eschenbach, Commissioner of Food and Drugs, affirming their commitment to reaching a conference report to reauthorize the drug and device user fee programs, the Best Pharmaceuticals for Children Act, and the Pediatric Research Equity Act, and provide important new authorities to improve post-market drug safety, establish a clinical trial registry and results database, and improve food safety.

This afternoon, Commissioner von Eschenbach sent a letter urging the Congress to reauthorize these programs by September 21.

Senator Kennedy said, "Both the public and FDA's dedicated employees should rest assured that we will reauthorize the important user fee and pediatric drug programs. The American people also urgently need improved drug and food safety, and we will work though August to produce an FDA bill that addresses all of these major concerns, for quick passage when we return in September."

Majority Leader Reid said, "Both chambers have passed legislation reauthorizing vital FDA programs and both bills contain other key improvements that will improve the lives of American patients and consumers. Chairmen Kennedy and Dingell have worked tirelessly in engaging the other side of the aisle to ensure that this legislation is finalized and sent to the President in a timely fashion. Speaker Pelosi and I have committed to doing all we can to help in that endeavor. We look forward to working over the August recess to finalize a package that will revitalize and improve the FDA."

Speaker Pelosi said, "We will complete action on this legislation so the dedicated federal employees of the FDA will not face termination notices. It is also critical that Congress pass the strongest drug safety provision so the American people can have complete confidence that prescription drugs are safe. Drug safety should be a priority of the Congress, and a top goal of the drug industry."

"I look forward to continued progress in our efforts to provide FDA with the resources it needs to safeguard the public health and to ensure that American consumers have timely access to safe and effective prescription drugs and medical devices," said Congressman Dingell.

August 3, 2007

The Honorable Andrew C. von Eschenbach, M.D.
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857

Dear Commissioner von Eschenbach:

As you know, both the Senate and the House have recently passed legislation—by overwhelming margins—that would reauthorize the prescription drug and medical device user fee programs, the Best Pharmaceuticals for Children Act, and the Pediatric Research Equity Act. This legislation also incorporates provisions that would make critical improvements in the Food and Drug Administration's (FDA) authorities and resources for oversight of post-market drug safety, establish for the first time a mandatory clinical trials registry and results database, and improve FDA's food safety oversight.

Since the passage of the House legislation on July 11, 2007, staff from the Senate Committee on Health, Education, Labor, and Pensions and the House Committee on Energy and Commerce has engaged in extensive bipartisan negotiations to craft a conference agreement. These negotiations have been highly productive and a great deal of progress and consensus has been attained. We wanted you to know that we will continue our work during August to finalize a conference report that Congress can act on early next month.

The American public deserves a strong and effective FDA, which only its highly qualified employees can provide. You and each of the dedicated employees of the FDA should have every confidence that Congress will reauthorize these important public health programs in early September.


Nancy Pelosi Harry Reid
Speaker of the House Senate Majority Leader

John D. Dingell Edward M. Kennedy
Chairman Chairman
House Committee on Senate Committee on Health,
Energy and Commerce Education, Labor, and Pensions

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