3.0.0 250 2023-01-11T13:46:38Z 2023-01-11T13:46:38Z Senate S 2021-02-04 117 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2021-02-05T00:36:37Z Fairness in Orphan Drug Exclusivity Act 117 1629 HR 2021-05-20 Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Related bill CRS 2021-02-04 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2021-02-04 Introduced in Senate IntroReferral 10000 9 Library of Congress C001075 Sen. Cassidy, Bill [R-LA] Bill Cassidy R LA N B001230 Sen. Baldwin, Tammy [D-WI] Tammy Baldwin D WI 2021-02-04 True S001181 Sen. Shaheen, Jeanne [D-NH] Jeanne Shaheen D NH 2021-02-04 True Health Competition and antitrust Drug safety, medical device, and laboratory regulation Licensing and registrations Marketing and advertising Prescription drugs Health 00 2021-02-04 Introduced in Senate 2021-09-07T18:03:49Z 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 specifically within its first 12 years of U.S. sales of the drug. This requirement shall also apply retroactively to an orphan drug that was granted such an exclusivity period before this bill's enactment.

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 Fairness in Orphan Drug Exclusivity Act Official Title as Introduced A bill 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. Introduced in Senate IS Short Title(s) as Introduced Fairness in Orphan Drug Exclusivity Act Introduced in Senate IS Introduced in Senate 2021-02-04T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-117s250is/xml/BILLS-117s250is.xml 2021-02-04 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.