US HB1353 | 2015-2016 | 114th Congress
Status
Spectrum: Bipartisan Bill
Status: Introduced on March 13 2015 - 25% progression, died in committee
Action: 2015-03-20 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]
Status: Introduced on March 13 2015 - 25% progression, died in committee
Action: 2015-03-20 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]
Summary
PATIENT Act of 2015 Promoting Access for Treatments Ideal in Enhancing New Therapies Act of 2015 This bill amends the Federal Food, Drug, and Cosmetic Act to extend to five years the three-year marketing exclusivity period provided to certain new drugs that include an active ingredient that was already approved by the Food and Drug Administration. A drug is provided this extended exclusivity period if it is approved for a new indication or use, or the drug has been reformulated or redesigned to: promote greater patient adherence to an approved treatment regime, reduce the public health risks associated with the drug, reduce side effects or adverse events, provide benefits to the health-care system, or provide other comparable patient benefits.
Title
PATIENT Act of 2015 Promoting Access for Treatments Ideal in Enhancing New Therapies Act of 2015
Sponsors
Rep. Gus Bilirakis [R-FL] | Rep. Gerald Connolly [D-VA] | Rep. Steve Israel [D-NY] | Rep. Morgan Griffith [R-VA] |
Rep. Susan Brooks [R-IN] |
History
Date | Chamber | Action |
---|---|---|
2015-03-20 | House | Referred to the Subcommittee on Health. |
2015-03-13 | House | Referred to the House Committee on Energy and Commerce. |
2015-03-13 | House | Introduced in House |
Subjects
Administrative law and regulatory procedures
Department of Health and Human Services
Drug safety, medical device, and laboratory regulation
Health
Prescription drugs
Department of Health and Human Services
Drug safety, medical device, and laboratory regulation
Health
Prescription drugs
US Congress State Sources
Type | Source |
---|---|
Summary | https://www.congress.gov/bill/114th-congress/house-bill/1353/all-info |
Text | https://www.congress.gov/114/bills/hr1353/BILLS-114hr1353ih.pdf |