On the recordJuly 11, 2007
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 FDA's ability to protect the American public due to recent outbreaks of food-borne illnesses as well as high-profile post-market 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 than 1,100 new medicines and reduce review times for innovative drugs and biologics, 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.
Source
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