3.0.0 3947 2022-11-01T13:50:24Z 2022-11-01T13:50:24Z House HR 2019-07-24 116 [Congressional Record Volume 165, Number 125 (Wednesday, July 24, 2019)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. MEADOWS:H.R. 3947.Congress has the power to enact this legislation pursuantto the following:Article 1, Section 8, Clause 3 ``The Congress shall havePower To . . . regulate Commerce . . . among the severalStates . . . .''[Page H7378]]]> hsju00 Judiciary Committee House Standing hsju10 Constitution and Limited Government Subcommittee Referred to 2019-08-28T19:46:21Z hsju05 Administrative State, Regulatory Reform, and Antitrust Subcommittee Referred to 2019-08-28T19:46:10Z hsju03 Courts, Intellectual Property, and the Internet Subcommittee Referred to 2019-08-28T19:45:45Z Referred to 2019-07-24T14:00:45Z hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2019-07-25T17:44:29Z Referred to 2019-07-24T14:00:35Z hsas00 Armed Services Committee House Standing hsas02 Military Personnel Subcommittee Referred to 2019-07-25T16:54:22Z Referred to 2019-07-24T14:00:50Z hswm00 Ways and Means Committee House Standing hswm02 Health Subcommittee Referred to 2019-07-24T19:01:37Z Referred to 2019-07-24T14:00:40Z hsgo00 Oversight and Accountability Committee House Standing Referred to 2019-07-24T14:01:00Z Fixing Global Freeloading Act 116 2209 HR 2019-04-10 Referred to the Subcommittee on Trade. Related bill CRS Securing America’s Medical Supply Chain and Advancing the Production of Life Saving Medicines Act 116 3942 S 2020-06-11 Read twice and referred to the Committee on Finance. Related bill CRS CREATES Act of 2019 116 965 HR 2019-05-16 Supplemental report filed by the Committee on the Judiciary, H. Rept. 116-55, Part III. Related bill CRS Fair Care Act of 2019 116 1332 HR 2019-02-26 Referred to the Subcommittee on Health. Related bill CRS 2019-08-28 hsju10 Constitution and Limited Government Subcommittee 1 House committee actions Referred to the Subcommittee on the Constitution, Civil Rights, and Civil Liberties. Committee 2019-08-28 hsju05 Administrative State, Regulatory Reform, and Antitrust Subcommittee 1 House committee actions Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law. Committee 2019-08-28 hsju03 Courts, Intellectual Property, and the Internet Subcommittee 1 House committee actions Referred to the Subcommittee on Courts, Intellectual Property, and the Internet. Committee 2019-07-25 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2019-07-25 hsas02 Military Personnel Subcommittee 1 House committee actions Referred to the Subcommittee on Military Personnel. Committee 2019-07-24 hswm02 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2019-07-24 Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, the Judiciary, Armed Services, and Oversight and Reform, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. IntroReferral H11100 2 House floor actions hsgo00 Oversight and Accountability Committee 2019-07-24 Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, the Judiciary, Armed Services, and Oversight and Reform, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. IntroReferral H11100 2 House floor actions hsas00 Armed Services Committee 2019-07-24 Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, the Judiciary, Armed Services, and Oversight and Reform, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. IntroReferral H11100 2 House floor actions hsju00 Judiciary Committee 2019-07-24 Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, the Judiciary, Armed Services, and Oversight and Reform, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. IntroReferral H11100 2 House floor actions hswm00 Ways and Means Committee 2019-07-24 Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, the Judiciary, Armed Services, and Oversight and Reform, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2019-07-24 Introduced in House IntroReferral Intro-H 9 Library of Congress 2019-07-24 Introduced in House IntroReferral 1000 9 Library of Congress M001187 Rep. Meadows, Mark [R-NC-11] Mark Meadows R NC 11 N Health Administrative law and regulatory procedures Administrative remedies Civil actions and liability Competition and antitrust Consumer affairs Contracts and agency Department of Health and Human Services Drug safety, medical device, and laboratory regulation Employee benefits and pensions Federal district courts Federal preemption Government employee pay, benefits, personnel management Government information and archives Health care costs and insurance Health information and medical records Health technology, devices, supplies Inflation and prices Insurance industry and regulation Licensing and registrations Medicaid Medical ethics Medical research Medicare Military medicine Prescription drugs Product development and innovation Research and development Retail and wholesale trades Right of privacy Health 00 2019-07-24 Introduced in House 2021-02-21T03:03:31Z Competition Prescription Act of 2019

This bill revises various requirements related to the development, production, and sale of prescription drugs and biological products.

First, the bill permits the developer of a drug or biological product to bring a civil action against the license holder of an approved product if the license holder has declined to make available sufficient quantities of the approved product for the developer's testing.

The bill also requires the Food and Drug Administration (FDA) to establish a process for developers of generic complex drugs to request and receive expedited development and priority review. Further, upon request by a drug sponsor, a drug that treats a life-threatening disease or condition must be designated for expedited review if there are fewer than three drugs currently available for such treatment.

States are prohibited from placing restrictions on dispensing substitute biological products that have been determined to be interchangeable with another product by the FDA.

Additionally, the bill prohibits sponsors of Medicare Part D prescription drug plans from reducing a payment to a pharmacy after a claim without defect has been submitted by such pharmacy. The bill establishes requirements for pricing standards for pharmacy benefits managers under Medicare and other federal prescription drug benefits programs. Starting in 2025, the bill removes the cap on rebates paid by manufacturers of outpatient prescription drugs under Medicaid.

Further, the bill requires the publication of specified information regarding licensed biological products, exempts from antitrust prohibitions specified drug-price negotiation strategies, and establishes a Chief Pharmaceutical Negotiator in the Office of the U.S. Trade Representative.


]]> Competition Prescription Act of 2019 Display Title Competition Prescription Act of 2019 Official Title as Introduced To lower the cost of prescription drugs, and for other purposes. Introduced in House IH Short Title(s) as Introduced Competition Prescription Act of 2019 Introduced in House IH Introduced in House 2019-07-24T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116hr3947ih/xml/BILLS-116hr3947ih.xml 2019-08-28 Referred to the Subcommittee on the Constitution, Civil Rights, and Civil Liberties. 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.