US HB909 | 2015-2016 | 114th Congress
Status
Sponsorship: Slight Partisan Bill (Republican 7-4)
Status: Introduced on February 12 2015 - 25% progression, died in committee
Action: 2015-02-13 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]
Status: Introduced on February 12 2015 - 25% progression, died in committee
Action: 2015-02-13 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]
Summary
Andrea Sloan CURE Act Andrea Sloan Compassionate Use Reform and Enhancement Act Amends the Federal Food, Drug, and Cosmetic Act to require the sponsor of an “investigational drug” (which is a drug that is designated as a breakthrough therapy, fast track product, infectious disease product, or drug for a rare disease or condition) to submit to the Food and Drug Administration (FDA) and make available to the public the sponsor's policy on requests for expanded access to the unapproved drug, including the minimum criteria for considering or approving requests and the time needed to make a decision. Requires an investigational drug sponsor to explain a denied request for expanded access to the person who made the request. Directs the Department of Health and Human Services to establish an Expanded Access Task Force. Requires the Task Force and the Government Accountability Office (GAO) to evaluate patient access to investigational drugs and make recommendations for improving access. Directs the FDA to finalize the draft guidance entitled “Expanded Access to Investigational Drugs for Treatment Use--Qs & As,” taking into account reports from the Task Force and GAO.
Title
Andrea Sloan CURE Act Andrea Sloan Compassionate Use Reform and Enhancement Act
Sponsors
| Rep. Michael McCaul [R-TX] | Rep. G. Butterfield [D-NC] | Rep. Michael Burgess [R-TX] | Rep. Morgan Griffith [R-VA] |
| Rep. Doris Matsui [D-CA] | Rep. Leonard Lance [R-NJ] | Rep. Jeff Fortenberry [R-NE] | Rep. Richard Hanna [R-NY] |
| Rep. Scott Peters [D-CA] | Rep. Timothy Walz [D-MN] | Sen. Kevin Cramer [R-ND] |
History
| Date | Chamber | Action |
|---|---|---|
| 2015-02-13 | House | Referred to the Subcommittee on Health. |
| 2015-02-12 | House | Referred to the House Committee on Energy and Commerce. |
| 2015-02-12 | House | Introduced in House |
Subjects
Administrative law and regulatory procedures
Administrative remedies
Advisory bodies
Congressional oversight
Consumer affairs
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)
Government information and archives
Government studies and investigations
Health
Health care coverage and access
Administrative remedies
Advisory bodies
Congressional oversight
Consumer affairs
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)
Government information and archives
Government studies and investigations
Health
Health care coverage and access
US Congress State Sources
| Type | Source |
|---|---|
| Summary | https://www.congress.gov/bill/114th-congress/house-bill/909/all-info |
| Text | https://www.congress.gov/114/bills/hr909/BILLS-114hr909ih.pdf |
