3.0.0 456 2024-07-24T15:24:03Z 2024-07-24T15:24:03Z House H HR 2023-01-24 118 hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2023-02-03T19:27:02Z Referred to 2023-01-24T17:02:35Z 2023-02-03 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2023-01-24 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2023-01-24 Introduced in House IntroReferral Intro-H 9 Library of Congress 2023-01-24 Introduced in House IntroReferral 1000 9 Library of Congress C001103 Rep. Carter, Earl L. "Buddy" [R-GA-1] Earl Carter R GA L. "Buddy" 1 N Health Health 2023-02-08T01:00:41Z 00 2023-01-24 Introduced in House 2023-06-02T11:16:52Z Fairness in Orphan Drug Exclusivity Act

This bill limits which orphan drugs may be granted a market exclusivity period by the Food and Drug Administration (FDA). (Generally, an orphan drug is one that is not economically viable because of the rarity of the disease that it treats; the sponsor of an FDA-designated orphan drug may be granted various incentives, such as a seven-year period in which the FDA may not grant market approval to a different sponsor for the same drug to treat the same disease.)

Under this bill, if a drug is designated as an orphan drug on the basis that there is no reasonable expectation that the sponsor will recover the costs of developing and distributing the drug from U.S. sales, the drug shall be granted the seven-year exclusivity period only if the sponsor demonstrates that there is no reasonable expectation that it will recover such costs within its first 12 years of U.S. sales of the drug.

When deciding whether an orphan drug meets this requirement, the FDA shall consider the sales of all drugs from the sponsor that are covered by the same orphan drug designation.

]]> Fairness in Orphan Drug Exclusivity Act Display Title 45 Fairness in Orphan Drug Exclusivity Act 2024-07-24T15:24:03Z Short Title(s) as Introduced 101 Fairness in Orphan Drug Exclusivity Act 2024-05-24T13:42:55Z Introduced in House IH Official Title as Introduced 6 To amend the Federal Food, Drug, and Cosmetic Act with respect to limitations on exclusive approval or licensure of orphan drugs, and for other purposes. 2024-03-18T20:13:14Z Introduced in House IH Introduced in House 2023-01-24T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-118hr456ih/xml/BILLS-118hr456ih.xml 2023-02-03 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.