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. Congress had also made user fee authorizing legislation in 2007 a vehicle for addressing other FDA-related issues. This report provides a legislative analysis of the provisions in S. 3187 and H.R. 5651 , including brief summaries of relevant provisions in current law, mostly the Federal Food, Drug, and Cosmetic Act (FFDCA). Current law descriptions generally relate only to provisions that the bills would change; the current law column, therefore, does not always provide a complete description of the relevant law. 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. In Tables 1 through 4, which describe the legislative language for four user fee programs, the Senate and House descriptions are merged in one column because of their substantive similarity (the few differences are noted). Tables 3, 4, and 11 address new provisions and do not, therefore, have current law columns. The remaining tables have three columns: current law, S. 3187 , and H.R. 5651 . In each table, the rows generally follow the order of provisions in the Senate bill, with comparable House provisions, if any, described in the relevant Senate rows. House provisions without comparable Senate provisions are then presented in the order they appear in the House bill. 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. 5651 (as passed) covered in each table. This report is one in a suite of CRS products that provide detailed background and analysis of FDA-related issues. For further information on many of the issues that Members and panelists raised in the committee hearings leading up to these bills (including drug approval, development incentives, device regulation, pediatric drugs, and user fees), see the CRS website (the Medical Product Regulation listings at http://www.crs.gov/pages/subissue.aspx?cliid=2678 ) or contact [author name scrubbed], Specialist in Drug Safety and Effectiveness, or one of the other authors of this report. Titles I through IV of both the Senate and House bills would authorize FDA to collect user fees and direct the revenue to fund specified activities relating to prescription drugs, medical devices, generic drugs, and biosimilar biological products. The first two are reauthorizations of current programs; the second two would authorize new user fee programs. With the Prescription Drug User Fee Act in 1992, Congress authorized FDA to collect user fees from the manufacturers of brand-name prescription drugs and biological products and to use the revenue for specified activities. PDUFA became possible when FDA, industry, and Congress agreed on two concepts: (1) performance goals —FDA would commit to performance goals it would negotiate with industry that set target completion times for various review processes; and (2) use of fees —the revenue from prescription drug user fees would be used only for activities to support the review of human drug applications and would supplement—rather than replace—funding that Congress appropriated to FDA. The added resources from user fees allowed FDA to increase staff to review what was then a backlog of new drug applications and to reduce application review times. Over the years, Congress has added similar authority regarding medical devices and animal drugs. User fees make up 35% of the FY2012 FDA budget. Their contribution to FDA's human drug program is larger at 51%. Following the precedent set by PDUFA, all the user fee programs addressed in this legislation include both (1) legislation and (2) performance goals agreements developed with representatives of the regulated industry in consultation with representatives of patients and advocates, academic and science experts, and congressional committees. FDA may use the revenue from PDUFA fees to support "the process for the review of human drug applications." With each reauthorization of PDUFA, Congress has expanded the range of activities included in that phrase. The prescription drug user fee program covers new drugs whose sponsors are the first to apply for marketing approval (excluding, therefore, generic drugs) and new biological products (excluding, therefore, the new category of biosimilar biological projects). Material in Table 1 refers to changes that S. 3187 (as passed) and H.R. 5651 (as passed) would make to current law. Unless otherwise noted, the PDUFA provisions in S. 3187 , H.R. 5651 , and the HHS-proposed legislative language are substantively the same. For a more complete description of current law and discussion of issues relating to the Prescription Drug User Fee Act, see CRS Report R42366, Prescription Drug User Fee Act (PDUFA): Issues for Reauthorization (PDUFA V) in 2012 , by [author name scrubbed]. Congress gave FDA the authority to collect fees from the medical device industry in 2002. User fees and direct appropriations from Congress fund review of medical devices by the FDA. Medical devices are a wide range of products that are used to diagnose, treat, monitor, or prevent a disease or condition in a patient. For many medical devices, FDA approval or clearance must be obtained prior to marketing in the United States. The purpose of user fees is to support the FDA's medical device premarket review program and to help reduce the time it takes the agency to review and make decisions on marketing applications. The user fee law provides revenue for FDA; in conjunction, the agency negotiates with industry to set performance goals for the premarket review of medical devices. The medical device user fee program was modeled after PDUFA program. Table 2 refers to changes in current law that would be made by Sections 202 and 203 of S. 3187 (as passed), and Sections 202 and 203 of H.R. 5651 (as passed). The language in these sections of the two bills is virtually identical. For a more complete description of the MDUFA program see CRS Report R42508, The FDA Medical Device User Fee Program , by [author name scrubbed]. Material in Table 3 refers to the legislation that would authorize the collection and use of generic drug user fees. The Generic Drug User Fee Amendments (GDUFA) titles in S. 3187 (as passed) and H.R. 5651 (as passed) would create new FFDCA sections 744A, B, C and are patterned after PDUFA, which was first enacted in 1992 and reauthorized in five-year increments. GDUFA would become effective October 1, 2012, or upon enactment, and would sunset on October 1, 2017. Unless otherwise noted, the GDUFA provisions in S. 3187 , H.R. 5651 , and the HHS-proposed legislative language are substantively the same. Integral to the operation of the generic drug user program are the performance goals stated in the FDA-industry agreement that the HHS Secretary submitted to Congress along with proposed legislative language. For a description of that agreement and a discussion of issues relating the proposed Generic Drug User Fee Amendments of 2012, see CRS Report R42540, Proposed FDA User Fee Acts: Generic Drug User Fee Amendments of 2012 (GDUFA) and Biosimilar User Fee Act of 2012 (BSUFA) , by [author name scrubbed] and [author name scrubbed]. A biosimilar is a biological product that is highly similar to a brand-name (innovator) biological product made by a pharmaceutical or biotechnology company. A biological product, or biologic, is a preparation, such as a drug or a vaccine, that is made from living organisms. In contrast to the relatively simple structure and manufacture of chemical drugs, biosimilars, with their more complex nature and method of manufacture, will not be identical to the brand-name product, but may instead be shown to be highly similar. The biotechnology industry began developing its first biologics for use as human therapeutic agents in the late 1970s and early 1980s. Biotechnology products are expected to become a larger share of the drugs sold by the pharmaceutical industry to U.S. consumers. However, with no parallel to the generic alternatives for chemical drugs, the cost of therapeutic biologics is often prohibitively high for individual patients.