3.0.0 297 2023-01-11T13:34:50Z 2023-01-11T13:34:50Z Senate S 2017-02-02 115 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2017-02-03T01:08:06Z Lower Drug Costs through Competition Act 115 749 HR 2017-02-03 Referred to the Subcommittee on Health. Related bill CRS 2017-02-02 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2017-02-02 Introduced in Senate IntroReferral 10000 9 Library of Congress C001035 Sen. Collins, Susan M. [R-ME] Susan Collins R ME M. N M001170 Sen. McCaskill, Claire [D-MO] Claire McCaskill D MO 2017-02-02 True T000464 Sen. Tester, Jon [D-MT] Jon Tester D MT 2017-03-06 False Health Congressional oversight Drug safety, medical device, and laboratory regulation Drug trafficking and controlled substances Government studies and investigations Infectious and parasitic diseases Licensing and registrations Prescription drugs User charges and fees Health 00 2017-02-02 Introduced in Senate 2017-03-06T17:22:49Z Increasing Competition in Pharmaceuticals Act

This bill amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding review and approval of generic drug applications or supplements to generic drug applications for drugs: (1) for which there is a shortage, or (2) that have not been recently introduced to the market by more than one manufacturer and for which tentative approval has not been granted to more than two applications.

The Food and Drug Administration (FDA) must prioritize the review of such submissions and act on them within 150 days. User fees are waived for such an application unless the drug is under patent. The FDA may expedite the inspection of a facility proposed to manufacture such a drug.

The FDA must award a transferrable generic drug priority review voucher to the sponsor of such an application upon approval. A voucher may be used to have the FDA review and take action upon a generic drug application within 150 days of submission. The FDA may revoke a voucher awarded for a drug that is not marketed within one year of approval. This voucher program is terminated at the end of FY2022.

The FDA must periodically report on generic drug applications filed before FY2016 that are still pending.

For a new drug application to be eligible for a priority review voucher as a tropical disease product application, the application must include new, essential clinical investigations.

The Government Accountability Office must study the FDA's program for drug risk evaluation and mitigation strategies.]]> Increasing Competition in Pharmaceuticals Act Display Title Increasing Competition in Pharmaceuticals Act Official Title as Introduced A bill to increase competition in the pharmaceutical industry. Introduced in Senate IS Short Titles as Introduced Increasing Competition in Pharmaceuticals Act Introduced in Senate 2017-02-02T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-115s297is/xml/BILLS-115s297is.xml 2017-02-02 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. 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.