Date: 2007-07-11
Speaker: VAN HOLLEN (democrat)
Chamber: H

Mr. Speaker. I rise in support of H.R. 2900. the Food and Drug Administration Amendments Act of 2007. I am proud that the headquarters of the Food and Drug Administration (FDA) is located in the Congressional District that I represent. I commend the hard working employees at FDA for their service and dedication to our country. However. serious gaps have been exposed in FDAs ability to protect the American public due to recent outbreaks of foodborne illnesses as well as highprofile postmarket safety problems. It has become clear that FDA lacks the adequate resources to fulfill its vast and vital public health mission. In light of these events. we need to ensure that the FDA has the necessary tools and resources to protect the American public from unsafe products. H.R. 2900 takes a good first step in providing FDA with those resources in reauthorizing the Prescription Drug User Fee Act (PDUFA). Since its inception in 1992. PDUFA has helped enable FDA to approve more thanr 1.100 new medicines and reduce review times for innovative. drugs and bio.logics. providing patients and doctors with earlier access to breakthrough treatments. Congress must reauthorize the prescription drug and medical device user fee programs in a timely manner to avoid any workforce disruptions at FDA. Without this bill. FDA will not have adequate resources to fulfill its mission. In addition. the innovation and development of new therapies will be hampered if PDUFA is not renewedthe FDA approval process will be too long for new potential treatments.- With this reauthorization. the FDA will be permitted to collect a total of $393 million in prescription drug user fees per year through FY 2012. H.R. 2900 also expands the FDAs ability to monitor the safety of drugs after they have been approved and marketed. In addition. the legislation creates a public database for ongoing and completed clinical trials. It is important to have all the information about any drug during the trial stage be disclosed to the public so that doctors can make sound medical decisions and provide their patients with the best possible care. I am also pleased that the legislation includes a provision that expands on the successful Critical Path Initiative. FDA established the Critical Path Initiative in 2004 to improve the efficiency and safety of drug and medical product development. This provision authorizes the FDA to enter into Critical Path PublicPrivate Partnerships with universities and nonprofit organizations to modernize the process to develop prescription drugs and other medical products. These collaborations will help the FDA move drugs and medical devices through the approval process in a quicker. safer and more reliable manner at a lower cost. Mr. Speaker. the Food and Drug Administration Amendments Act is only one important step in providing FDA with the necessary tools and resources to do its job. Congress must also significantly increase federal appropations to FDA so that the agency is able to fulfill its most basic responsibilities. Such an increase will not only -make foods. drugs and devices safer. but it will also lead to a stronger. more effective FDA that can restore public confidence. speed innovation and ensure that America remains competitive in foreign markets. I believe H.R. 2900 will help ensure the timely access to safe and effective prescription drugs and medical devices as well as improve the integrity of the drug approval process at FDA. I urge my colleagues to support H.R.