3.0.0 3271 2022-02-09T00:55:56Z 2022-02-09T00:55:56Z Senate S 2020-02-11 116 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2020-02-11T20:06:55Z Fairness in Orphan Drug Exclusivity Act 116 4712 HR 2020-11-18 Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Related bill CRS 2020-02-11 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2020-02-11 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 2020-02-11 True S001181 Sen. Shaheen, Jeanne [D-NH] Jeanne Shaheen D NH 2020-02-11 True Health Competition and antitrust Drug safety, medical device, and laboratory regulation Licensing and registrations Marketing and advertising Prescription drugs Health 00 2020-02-11 Introduced in Senate 2021-09-07T20:43:13Z 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.)

Specifically, when determining whether to grant an exclusivity period to a drug that has orphan status due to low expected sales, the FDA must 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 Short Title(s) as Introduced Fairness in Orphan Drug Exclusivity Act Introduced in Senate IS 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 Introduced in Senate 2020-02-11T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116s3271is/xml/BILLS-116s3271is.xml 2020-02-11 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.