KENNEDY, REID, PELOSI, DINGELL REAFFIRM COMMITMENT TO REAUTHORIZING PUBLIC HEALTH LEGISLATION

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 aconference report to reauthorize the drug and device user fee programs, the BestPharmaceuticals for Children Act, and the Pediatric Research Equity Act, and provide importantnew authorities to improve post-market drug safety, establish a clinical trial registry andresults database, and improve food safety. This afternoon, Commissioner von Eschenbach sent a letter urging the Congress to reauthorizethese programs by September 21. Senator Kennedy said, “Both the public and FDA's dedicated employees should rest assuredthat we will reauthorize the important user fee and pediatric drug programs. The Americanpeople also urgently need improved drug and food safety, and we will work though August toproduce an FDA bill that addresses all of these major concerns, for quick passage when wereturn in September.” Majority Leader Reid said, "Both chambers have passed legislation reauthorizing vital FDAprograms and both bills contain other key improvements that will improve the lives ofAmerican patients and consumers. Chairmen Kennedy and Dingell have worked tirelessly inengaging the other side of the aisle to ensure that this legislation is finalized and sent to thePresident in a timely fashion. Speaker Pelosi and I have committed to doing all we can to helpin that endeavor. We look forward to working over the August recess to finalize a packagethat will revitalize and improve the FDA." Speaker Pelosi said, “We will complete action on this legislation so the dedicated federalemployees of the FDA will not face termination notices. It is also critical that Congress passthe strongest drug safety provision so the American people can have complete confidence thatprescription drugs are safe. Drug safety should be a priority of the Congress, and a top goalof the drug industry.” "I look forward to continued progress in our efforts to provide FDA with the resources it needsto safeguard the public health and to ensure that American consumers have timely access tosafe and effective prescription drugs and medical devices," said Congressman Dingell. August 3, 2007 The Honorable Andrew C. von Eschenbach, M.D. CommissionerFood and Drug Administration5600 Fishers LaneRockville, Maryland 20857 Dear Commissioner von Eschenbach:As you know, both the Senate and the House have recently passed legislation—byoverwhelming margins—that would reauthorize the prescription drug and medical device userfee programs, the Best Pharmaceuticals for Children Act, and the Pediatric Research EquityAct. This legislation also incorporates provisions that would make critical improvements in theFood and Drug Administration’s (FDA) authorities and resources for oversight of post-marketdrug safety, establish for the first time a mandatory clinical trials registry and resultsdatabase, and improve FDA’s food safety oversight. Since the passage of the House legislation on July 11, 2007, staff from the Senate Committeeon Health, Education, Labor, and Pensions and the House Committee on Energy andCommerce has engaged in extensive bipartisan negotiations to craft a conference agreement. These negotiations have been highly productive and a great deal of progress and consensushas been attained. We wanted you to know that we will continue our work during August tofinalize a conference report that Congress can act on early next month. The American public deserves a strong and effective FDA, which only its highlyqualified employees can provide. You and each of the dedicated employees of the FDA shouldhave every confidence that Congress will reauthorize these important public health programsin early September. Sincerely,Nancy Pelosi Harry ReidSpeaker of the House Senate Majority LeaderJohn D. Dingell Edward M. KennedyChairman ChairmanHouse Committee on Senate Committee onHealth,Energy and Commerce Education, Labor, andPensions