3.0.0 670 2023-03-08T20:12:35Z 2023-03-08T20:12:35Z Senate S 2021-03-10 117 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2021-03-10T20:21:50Z Speeding Therapy Access Today Act of 2021 117 1730 HR 2021-03-10 Referred to the Subcommittee on Health. Identical bill CRS 2021-03-10 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2021-03-10 Introduced in Senate IntroReferral 10000 9 Library of Congress K000367 Sen. Klobuchar, Amy [D-MN] Amy Klobuchar D MN N W000437 Sen. Wicker, Roger F. [R-MS] Roger Wicker R MS F. 2021-03-10 True Health Advisory bodies Department of Health and Human Services Drug safety, medical device, and laboratory regulation Drug therapy Executive agency funding and structure Food and Drug Administration (FDA) Health technology, devices, supplies Manufacturing Medical research Research administration and funding Health 00 2021-03-10 Introduced in Senate 2021-06-23T23:35:46Z Speeding Therapy Access Today Act of 2021

This bill requires and authorizes various actions to accelerate the development of therapies for rare diseases.

The Food and Drug Administration (FDA) shall establish the Intercenter Institute on Rare Diseases and Conditions. The institute shall (1) coordinate engagement with relevant stakeholders, (2) build the FDA's expertise in the review of medical products to treat rare diseases, (3) coordinate regulatory science initiatives related to rare diseases, (4) establish and implement a program to make recommendations to address challenges associated with developing medical products to treat rare diseases in an individual or in very small populations, (5) convene a stakeholder meeting to consider potential amendments to labels for medical products to treat rare diseases, and (6) establish and carry out a program to facilitate voluntary communication between the sponsors of such medical products and third-party payers (e.g., insurance companies).

The bill also authorizes the FDA to make grants to assist in developing practices related to the development and production of individualized therapies or therapies to treat very small populations.

The bill also establishes an advisory committee to advise the FDA on issues related to the development of therapies to treat rare diseases.

]]> Speeding Therapy Access Today Act of 2021 Display Title Speeding Therapy Access Today Act of 2021 Official Title as Introduced A bill to amend the Federal Food, Drug, and Cosmetic Act to accelerate development of therapies across the spectrum of rare diseases and conditions and facilitate patient access to such therapies, and for other purposes. Introduced in Senate IS Short Title(s) as Introduced Speeding Therapy Access Today Act of 2021 Introduced in Senate IS Introduced in Senate 2021-03-10T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-117s670is/xml/BILLS-117s670is.xml 2021-03-10 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.