	Introduction

The Senate and the House have each passed bills whose provisions would affect a broad range of Food and Drug Administration (FDA) activities regarding drugs, biological products, and medical devices: S. 3187 , the Food and Drug Administration Safety and Innovation Act, passed on May 24, 2012; and H.R. 5651 , the Food and Drug Administration Reform Act of 2012, passed on May 30, 2012. The timing of these bills coincides with the October 1, 2012 expiration of FDA's authority under current law to collect fees under the Prescription Drug User Fee Amendments (PDUFA) of 2007 and the Medical Device User Fee Amendments (MDUFA) of 2007. Because revenue from those fees supports over 2,000 full-time equivalent FDA positions and accounts for more than half of the agency's drug and device review resources, Members of Congress have referred to the user fee reauthorizations as generally uncontroversial, must-pass legislation. The Senate Committee on Health, Education, Labor, and Pensions and the House Committee on Energy and Commerce have, in addition to developing legislation that would reauthorize the drug and device user fees, crafted additional titles that would create new user fee authority for generic drugs and biosimilar biological products, permanently authorize programs to encourage or require studies of drugs for pediatric use, medical device regulation, drug regulation, and several areas, such as advisory committee conflict of interest, that cut across FDA product areas. This report provides a legislative analysis of the provisions in S. 3187 and H.R. Material is grouped by broad topics and presented in the general order of sections in the Senate bill, the first to be reported out of committee. The report begins each topic with a discussion of the overall issue to set the policy or legislative context of the bills' provisions and then uses a table to present the comparison of the bills and current law. 5651 . The following grid lists the tables that follow in this report; it also lists the section numbers of S. 3187 (as passed) and H.R. Their contribution to FDA's human drug program is larger at 51%. 5651 (as passed). Both S. 3187 and H.R. Medical device related provisions are presented in Table 6 , in the order in which they appear in the Senate bill. The agency continues its oversight of drug safety and effectiveness as long as the drug is on the market. Next Steps

The Senate voted 96-1 to pass S. 3187 on May 24, 2012. 5651 .
UPDATE: On June 18, 2012, the Senate Committee on Health, Education, Labor, and Pensions and the House Committee on Energy and Commerce distributed the text of an agreement that combined provisions of S. 3187 [ES], as passed by the Senate on May 24, 2012, and H.R. 5651 [EH], as passed by the House on May 30, 2012. The full House passed the new version by voice vote under suspension of the rules on June 20, 2012. On June 25, 2012, the Senate voted for cloture to limit debate on that bill, S. 3187 [EAH], the Food and Drug Administration Safety and Innovation Act of 2012 [hereinafter referred to as "the agreement"]. The Senate is expected to vote on the agreement sometime the week of June 25, 2012. For information on selected features of the agreement, see the Introduction of this report.
The Senate Committee on Health, Education, Labor, and Pensions and the House Committee on Energy and Commerce have worked for more than a year developing Food and Drug Administration (FDA)-related legislation, versions of which both chambers passed in the last week of May 2012. S. 3187 (the Food and Drug Administration Safety and Innovation Act) and H.R. 5651 (the Food and Drug Administration Reform Act of 2012) each include provisions that would affect the regulation of human drugs, biological products, and medical devices, along with several agency-wide administrative or miscellaneous items. Majority and minority committee leaders have expressed the desire to get a completed bill to the President before July 4, 2012.
The impetus to the timing of these bills is that current authority for FDA to collect fees under the Prescription Drug User Fee Amendments (PDUFA) of 2007 and the Medical Device User Fee Amendments (MDUFA) of 2007 will expire on October 1, 2012, unless reauthorizing legislation is enacted before then. Member statements at committee hearings indicated no opposition to reauthorization and very little comment about changes to the current user fee programs. Because Members of Congress generally consider the user fee reauthorizations to be must-pass legislation—for example, the user fee revenue accounts for more than half of the agency's human drug program budget—they have used these bills as vehicles for numerous additional measures.
The introduction to this report highlights selected features of S. 3187 [EAH], the agreement, relative to S. 3187 [ES] and H.R. 5651 [EH]. The remainder of this report provides, in a series of 14 tables, comparisons of the provisions in S. 3187 [ES] and H.R. 5651 [EH], presented generally in the order in which they appear in the Senate bill, the first to be reported by committee. Each table addresses a broad topic (e.g., human device regulation) and is preceded by narrative discussing the policy and legislative context of the table's provisions.