STATEMENT: Pallone on FDA Revitalization Act

PALLONE STATEMENT ON FDA REVITALIZATION ACT

Washington, D.C. --- U.S. Rep. Frank Pallone, Jr. (D-NJ), Chairman of the House Energy and Commerce Subcommittee on Health, gave the following statement on the House floor this afternoon in support of the Food and Drug Administration Revitalization Act of 2007.  The New Jersey congressman is one of the original authors of a bill that passed the House earlier this year. 

"Thank you, Madam Speaker.  This is an important day for American consumers.  Thanks to the legislation the House is about to pass, the Food and Drug Administration (FDA) will have the financial resources and authorities necessary to ensure patients have timely access to safe and effective therapies. 

"First and foremost this bill is about drug safety.  In order to empower the FDA to protect the public from harmful drugs, we are giving the agency new authority to compel important labeling changes.  This is a significant improvement over current policy, where FDA must haggle w/ drug companies in protracted negotiations that put patients and consumers at risk. 

"Under this bill, FDA will also be better equipped to force drug manufacturers to fulfill their responsibility to the American public and complete post-market study commitments, which are critical to ensuring a drug is safe. In addition to these important new authorities, this bill authorizes the collection of $225 million in new user fees, a significant increase in the amount of funds dedicated for the use of drug safety activities. 

"The FDA Revitalization Act also provides for commonsense improvements to our nation’s food safety system, such as more stringent ingredient and labeling standards, establishment of an adulterated food registry, and improvements in public notification.  

"Patients will be happy to know that the bill before us also requires greater transparency of drug makers by calling for clinical trials to be registered in a database monitored by the National Institutes of Health (NIH), along with basic results data.  As we saw with the case of Avandia, making this information available to patients, providers and researchers is critical to uncovering potential harmful effects of a drug.  Under this legislation, the public will also have greater access to internal documents that FDA used in its review of a drug application. 

"We also secure FDA scientists’ right to publish by requiring the Secretary to establish clear policies on the timely clearance of articles written by FDA employees.  Finally, this bill would make significant progress in reducing the number of conflicted experts who serve on advisory committees.

"Madam Speaker, I am also proud to say that this bill reauthorizes two very important programs for our nation’s children: the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research and Equity Act (PREA).  These programs have been crucial in the successful cultivation of important research used by doctors and parents to better determine what kind of drug therapy is safest and most appropriate for a child/patient.  

"In addition to the two existing programs, we are creating a new program that would help provide device manufacturers with greater incentives to conduct research and development of pediatric devices.  Combined, these three bills would strengthen the research being done on pediatric uses of drugs and devices and will make sure that our nation’s children have access to the medicines and therapies they need to grow up healthy and strong.  

"Finally, this bill reauthorizes two critically important user fee agreements with respect to prescription drugs and medical devices.  These programs provide FDA with the necessary resources to review applications in a timely manner so patients who rely on new and improving drugs and devices don’t have to go without.  In addition to reauthorizing these existing user fee programs, this bill would establish a new user fee for the specific purpose of reviewing direct-to-consumer advertisements. 

"In closing, I would like to commend Chairman Dingell who has led our efforts through this process.  His leadership on these issues has been unwavering and it is to his credit that we have a bill on the floor today.  I would also like to thank Ranking Member Barton and Mr. Deal and their staffs for all the hard work they did to develop this bipartisan agreement.  

"This is a great victory for American consumers that will make tremendous strides in empowering the FDA and restoring public confidence in its ability to protect the public health.  I urge my colleagues on both sides of the aisle to vigorously support it.  Thank you."

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