FDA Legislation in the 110th Congress: A Side-by-Side Comparison of S. 1082 and H.R. 2900
Released: 2007-08-06T00:00:00

Summary:
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 set 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 a side-by-side comparison of S. 1082 and H.R. 2900, and includes links to relevant CRS reports. It will be updated as further legislative events warrant.

subsections: section_title: Introduction
paragraphs: 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 ). S. 1082 and H.R. 2900 represent the most comprehensive FDA legislation since the Food and Drug Administration Modernization Act of 1997 (FDAMA; P.L. 105-115 ).
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 ). FDA had reportedly urged Congress to complete its reauthorization efforts before August 1, 2007 (rather than by the program's termination date of October 1, 2007), because of a requirement that FDA notify employees at least 60 days in advance of layoffs, which would be necessary without PDUFA and MDUFMA funds. The media report that FDA has switched to reserve funds to forestall the issuance of layoff notifications, the effect of which is a hiring freeze at FDA. In addition, the FDA Commissioner has reportedly stressed that the funding uncertainty is harming the morale of employees—30% of which are at a point where they can retire.
The bills also would reauthorize two other expiring authorities, which are related to pediatric pharmaceuticals: the Best Pharmaceuticals for Children Act (BPCA; P.L. 105-115 ), reauthorized in P.L. 107-109, and the Pediatric Research Equity Act (PREA; P.L. 108-155 ). In addition, the bills address a number of other issues of concern to Congress and the public.
This report presents a side-by-side analysis of S. 1082 and H.R. 2900 , highlighting the differences between the bills. It contains individual tables on topics covered by the bills, including prescription drug user fees, medical device user fees, medical device regulation, pediatric exclusivity incentives (BPCA), mandatory pediatric assessments (PREA), pediatric medical devices, drug safety, antibiotic drugs, clinical trials databases, conflicts of interest, importation of prescription drugs, a new Reagan-Udall Foundation, food safety, domestic pet turtle market access, and other provisions. In general, provisions in the two bills amend FDA's authorities in the Federal Food, Drug and Cosmetic Act (FFDCA) or the Public Health Service Act (PHSA). Unless otherwise noted, mention of "the Secretary" in the following tables refers to the Secretary of Health and Human Services (HHS).
For background information on the impetus for this legislation and for an overview of the two bills, see CRS Report RL34089, FDA Legislation in the 110 th Congress: A Guide to S. 1082 and H.R. 2900 , by [author name scrubbed], [author name scrubbed], and [author name scrubbed].