3.0.0 1576 2023-01-11T13:28:03Z 2023-01-11T13:28:03Z House HR 2015-03-24 114 [Congressional Record Volume 161, Number 49 (Tuesday, March 24, 2015)]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. BURGESS:H.R. 1576.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8, Clause 1 of the United StatesConstitution, which grants Congress the power to lay andcollect taxes, duties, imposts and excises, to pay the debtsand provide for the common defense and general welfare of theUnited States.Article 1, Section 8, Clause 3, of the United StatesConstitution, which grants Congress the power to regulatecommerce with foreign nations, and among the several states,and with the Indian tribes.[Page H1901]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2015-03-27T20:30:39Z Referred to 2015-03-24T13:06:35Z 2015-03-27 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2015-03-24 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2015-03-24 Introduced in House IntroReferral Intro-H 9 Library of Congress 2015-03-24 Introduced in House IntroReferral 1000 9 Library of Congress B001248 Rep. Burgess, Michael C. [R-TX-26] Michael Burgess R TX C. 26 N B001251 Rep. Butterfield, G. K. [D-NC-1] G. K. Butterfield D NC 1 2015-03-24 True A000373 Rep. Ashford, Brad [D-NE-2] Brad Ashford D NE 2 2015-03-24 True B001257 Rep. Bilirakis, Gus M. [R-FL-12] Gus Bilirakis R FL M. 12 2015-03-24 True P000602 Rep. Pompeo, Mike [R-KS-4] Mike Pompeo R KS 4 2015-05-01 False K000378 Rep. Kinzinger, Adam [R-IL-16] Adam Kinzinger R IL 16 2015-05-21 False H001067 Rep. Hudson, Richard [R-NC-8] Richard Hudson R NC 8 2015-11-05 False C001092 Rep. Collins, Chris [R-NY-27] Chris Collins R NY 27 2015-11-19 False Health Congressional oversight Drug safety, medical device, and laboratory regulation Government studies and investigations Prescription drugs Health 00 2015-03-24 Introduced in House 2015-08-14T17:41:11Z Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015

This bill requires the Government Accountability Office (GAO) to study whether generic versions of certain complex drugs or certain biological drugs face significantly different challenges in meeting the approval standards of the Food and Drug Administration (FDA) than generic versions of small-molecule drugs. (Complex drugs and biological drugs can be composed of large molecules that are more difficult to fully characterize than small molecules, so it can be more difficult to demonstrate that generic versions of these drugs are the same as the brand name versions.)

If the GAO determines that these generic drugs face significantly different challenges, then the GAO must also determine: (1) the evidence that should be required to demonstrate that one of these generic drugs is sufficiently similar to the brand name drug in safety, composition, and activity; (2) whether the Federal Food, Drug, and Cosmetic Act should be amended to address the approval of these generic drugs; and (3) whether the FDA should develop a policy document on the evidence that is necessary to obtain approval of these generic drugs.]]> Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 Display Title Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 Official Title as Introduced To require a study by the Government Accountability Office (GAO) to assess the Food and Drug Administration's current regulatory pathway for reviewing generic versions of nonbiologic complex drug products, and for other purposes. Introduced in House IH Short Titles as Introduced Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 Introduced in House 2015-03-24T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114hr1576ih/xml/BILLS-114hr1576ih.xml 2015-03-27 Referred to the Subcommittee on Health. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.