3.0.0 6501 2023-01-11T13:33:54Z 2023-01-11T13:33:54Z House HR 2016-12-08 114 [Congressional Record Volume 162, Number 177 (Thursday, December 8, 2016)]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Ms. DeLAURO:H.R. 6501.Congress has the power to enact this legislation pursuantto the following:Article 1, Section 8, Clause 3 and Article 1, Section 8,Clause 18 of the United States Constitution.[Page H7570]]]> hsju00 Judiciary Committee House Standing hsju03 Courts, Intellectual Property, and the Internet Subcommittee Referred to 2016-12-22T18:01:25Z Referred to 2016-12-08T14:05:05Z hswm00 Ways and Means Committee House Standing Referred to 2016-12-08T14:05:00Z hsif00 Energy and Commerce Committee House Standing Referred to 2016-12-08T14:04:50Z 2016-12-22 hsju03 Courts, Intellectual Property, and the Internet Subcommittee 1 House committee actions Referred to the Subcommittee on Courts, Intellectual Property, and the Internet. Committee 2016-12-08 Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and the Judiciary, 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 2016-12-08 Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and the Judiciary, 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 2016-12-08 Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and the Judiciary, 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-A 9 Library of Congress 2016-12-08 Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and the Judiciary, 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 2016-12-08 Introduced in House IntroReferral Intro-H 9 Library of Congress 2016-12-08 Introduced in House IntroReferral 1000 9 Library of Congress D000216 Rep. DeLauro, Rosa L. [D-CT-3] ROSA DELAURO D CT 3 N S001145 Rep. Schakowsky, Janice D. [D-IL-9] JANICE SCHAKOWSKY D IL D. 9 2016-12-08 True D000399 Rep. Doggett, Lloyd [D-TX-35] LLOYD DOGGETT D TX 35 2016-12-08 True M000404 Rep. McDermott, Jim [D-WA-7] JIM MCDERMOTT D WA 7 2016-12-08 True H001034 Rep. Honda, Michael M. [D-CA-17] MICHAEL HONDA D CA M. 17 2016-12-08 True M001160 Rep. Moore, Gwen [D-WI-4] Gwen Moore D WI 4 2016-12-08 True K000009 Rep. Kaptur, Marcy [D-OH-9] MARCY KAPTUR D OH 9 2016-12-08 True W000800 Rep. Welch, Peter [D-VT-At Large] Peter Welch D VT 0 2016-12-08 True C000984 Rep. Cummings, Elijah E. [D-MD-7] ELIJAH CUMMINGS D MD E. 7 2016-12-23 False Health Administrative law and regulatory procedures Administrative remedies Advisory bodies Civil actions and liability Congressional oversight Consumer affairs Department of Health and Human Services Drug safety, medical device, and laboratory regulation Evidence and witnesses Food and Drug Administration (FDA) Government studies and investigations Health care costs and insurance Health technology, devices, supplies Inflation and prices Intellectual property Manufacturing Medicaid Prescription drugs Sales and excise taxes Health 00 2016-12-08 Introduced in House 2017-05-23T17:23:51Z Prescription Drug and Medical Device Price Review Board Act of 2016

This bill establishes the Prescription Drug and Medical Device Price Review Board within the Food and Drug Administration. Each manufacturer of a prescription drug or medical device that is sold in the United States must submit to the board:

  • each type of prescription drug and medical device that it sells in the United States, or in a country that is a member of the Organization for Economic Co-operation and Development;
  • the price charged by the manufacturer for the drug or device; and
  • the costs of the manufacturer to produce them.

The board must establish a formula for determining whether the average manufacturer price of a prescription drug or medical device over an annual quarter is an excessive price. Manufacturers may not charge excessive prices. Individuals may petition the board to determine whether the price for a prescription drug or medical device is excessive.

The board may subject violators to reduced patent terms, civil penalties, and increased Medicaid rebates. The bill amends the Internal Revenue Code to impose a tax on the sale of prescription drugs or medical devices that have excessive prices.

The board must allow individuals to import from approved counties prescription drugs and devices that are comparable to prescription drugs and devices with excessive prices.

]]> Prescription Drug and Medical Device Price Review Board Act of 2016 Display Title Prescription Drug and Medical Device Price Review Board Act of 2016 Official Title as Introduced To establish within the Food and Drug Administration the Prescription Drug and Medical Device Price Review Board to regulate the prices of certain prescription drugs and medical devices, and for other purposes. Introduced in House IH Short Titles as Introduced Prescription Drug and Medical Device Price Review Board Act of 2016 Introduced in House 2016-12-08T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114hr6501ih/xml/BILLS-114hr6501ih.xml 2016-12-22 Referred to the Subcommittee on Courts, Intellectual Property, and the Internet. 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.