3.0.0 7324 2023-01-11T13:40:47Z 2023-01-11T13:40:47Z House HR 2018-12-17 115 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. KELLY of Pennsylvania:H.R. 7324.Congress has the power to enact this legislation pursuantto the following:The Congress enacts this bill pursuant to Article I Section8 of the United States Constitution.[Page H10269]]]> hswm00 Ways and Means Committee House Standing hswm02 Health Subcommittee Referred to 2019-01-02T19:17:16Z Referred to 2018-12-17T16:31:50Z hsif00 Energy and Commerce Committee House Standing Referred to 2018-12-17T16:32:00Z 2019-01-02 hswm02 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2018-12-17 Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, 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 2018-12-17 Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, 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 2018-12-17 Introduced in House IntroReferral Intro-H 9 Library of Congress 2018-12-17 Introduced in House IntroReferral 1000 9 Library of Congress K000376 Rep. Kelly, Mike [R-PA-3] Mike Kelly R PA 3 N Health Drug safety, medical device, and laboratory regulation Drug therapy Health care coverage and access Prescription drugs User charges and fees Health 00 2018-12-17 Introduced in House 2019-09-03T22:07:09Z Preserving Access to Orphan Drugs Act of 2018

This bill amends the Patient Protection and Affordable Care Act to expand the definition of orphan drug for purposes of the annual fee paid by brand name prescription drug manufacturers and importers to include medications for rare conditions that were, prior to 2011, approved or in clinical trials. (Drug manufacturers and importers pay an annual fee based on their sales of brand name prescription drugs, excluding sales of orphan drugs.)

]]> Preserving Access to Orphan Drugs Act of 2018 Display Title Preserving Access to Orphan Drugs Act of 2018 Official Title as Introduced To clarify the orphan drug exception to the annual fee on branded prescription pharmaceutical manufacturers and importers, and for other purposes. Introduced in House IH Short Titles as Introduced Preserving Access to Orphan Drugs Act of 2018 Introduced in House 2018-12-17T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-115hr7324ih/xml/BILLS-115hr7324ih.xml 2019-01-02 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.