	Introduction

Both chambers of Congress have passed comprehensive legislation to reauthorize expiring programs at the Food and Drug Administration (FDA), and to expand the agency's authority to help ensure the safety of certain medical products. The bills are the Food and Drug Administration Revitalization Act ( S. 1082 ), and the Food and Drug Administration Amendments Act of 2007 ( H.R. 2900 ). The primary driver of the legislation is the renewal of FDA's authority for two key user fee programs set to expire at the end of FY2007: the Prescription Drug User Fee Act (PDUFA; P.L. 107-188 ), and the Medical Device User Fee and Modernization Act (MDUFMA; P.L. 107-250 ). The bills also would reauthorize two other expiring authorities, which are related to pediatric pharmaceuticals: the Best Pharmaceuticals for Children Act (BPCA; P.L. 107-109 ), and the Pediatric Research Equity Act (PREA; P.L. The agency also regulates the safety and effectiveness of human drugs, biologics (e.g., vaccines), medical devices, and animal drugs. Combined, these fees would account for 87% of FDA's user fee revenue, and 19% of its total program level budget in FY2008. BPCA and PREA provide marketing exclusivity incentives and requirements for studying pediatric use of both on - and off-patent drugs. 2900 contain provisions relating to the public registration of clinical trials and the public posting of their results. S. 1082 and H.R. The remaining sections of this report contain descriptions of the key FDA programs addressed in the bills, certain programs considered but not included in the bills, and links to relevant CRS reports. FDA's authority for the first of these (the collection of user fees) will expire on October 1, 2007, unless Congress reauthorizes it, as is proposed in S. 1082 (Title III), and H.R. They are set to expire on October 1, 2007. 108-155 ). According to the Senate bill, the Secretary, in addition to routine active surveillance and other requirements, would have "to assess a signal of a serious risk with use of a drug; or to identify, based on a review of a demonstrated pattern of use of the drug, unexpected serious risks in a domestic population...." The House bill, unlike S. 1082 , addressing this outside of the REMS process, would authorize the Secretary to require, based on scientific information, a postapproval study to assess a known risk, assess signals of serious risk, or to identify a serious risk. Miscellaneous Provisions in S. 1082

S. 1082 contains a number of provisions that are not present in H.R. 2900 contains no food provisions. 2900 . One states that legislation should be passed that allows the FDA appropriate flexibility in the regulation of follow-on biologics .
Both the House and the Senate have passed comprehensive legislation to reauthorize existing Food and Drug Administration (FDA) programs and expand the agency's authority to ensure the safety of prescription drugs, medical devices, and biologics. The Senate passed the Food and Drug Administration Revitalization Act (S. 1082) on May 9, 2007. The House passed the Food and Drug Administration Amendments Act of 2007 (H.R. 2900) on July 11, 2007.
At its core, the legislation renews authority for two key user fee programs that are set to expire on October 1, 2007: the Prescription Drug User Fee Act (PDUFA; P.L. 107-188) and the Medical Device User Fee and Modernization Act (MDUFMA; P.L. 107-250). These account for 87% of FDA's user fee revenue, and 19% of FDA's total FY2008 program level budget. Without the reauthorizations, and absent a substantial increase in FDA's annual appropriations, the agency would lose a significant source of funding. FDA had warned that a failure to reauthorize the user fee programs before August 1, 2007, would require the agency to issue layoff notices, but the agency has reportedly forestalled that necessity by switching to reserve funds.
In addition to user fee programs, the bills reauthorize two other FDA authorities related to prescription drugs for pediatric populations, which are also due to expire on October 1, 2007: the Best Pharmaceuticals for Children Act (BPCA; P.L. 107-109) and the Pediatric Research Equity Act (PREA; P.L. 108-155). These laws provide marketing exclusivity incentives and requirements for studying pediatric use of on-patent and off-patent drugs. S. 1082 and H.R. 2900 also contain provisions related to drug safety, pediatric medical devices, clinical trial registration, and the creation of a new nonprofit entity to assist FDA with its mission. The bills' overlapping provisions are similar, but not identical.
S. 1082 contains some additional provisions that are not present in H.R. 2900, on the topics of food safety, prescription drug importation, and domestic pet turtle market access. Attempts to expand the legislation to address several other FDA-related issues, for example, follow-on biologics and genetic testing, have thus far been unsuccessful. Differences between the bills may be addressed in conference.
This report contains background information about the FDA relevant to S. 1082 and H.R. 2900. It presents a comparative overview of the bills' contents, and contains links to pertinent CRS reports. This report will be updated as further legislative events warrant.