To amend section 505(c)(3)(E) of the Federal Food, Drug, and Cosmetic Act to prevent certain applications from being considered ineligible for approval under section 505(c) of such Act on the basis that the proposed labeling includes information describing abuse-deterrent properties that otherwise would be blocked by exclusivity under clause (iii) or (iv) of section 503(c)(3)(E) of such Act, and for other purposes.
USA115th CongressHR-2025| House
| Updated: 4/7/2017
H. Morgan Griffith
Republican Representative
Virginia
Cosponsors (1)
Health Subcommittee, Energy and Commerce Committee
- Introduced
- In Committee
- On Floor
- Passed Chamber
- Enacted
Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to prevent an application for a new drug from being considered ineligible for approval because its labeling includes information describing abuse-deterrent properties that otherwise would be blocked by market exclusivity provisions. The Department of Health and Human Services shall issue draft guidance and publish final guidance regarding the award and scope of exclusivity for new drugs with properties designed to deter abuse and the exceptions to such exclusivity. The bill applies to applications and supplements to applications that are submitted or pending approval on or after January 1, 2017.
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Timeline
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Health
Administrative law and regulatory proceduresDepartment of Health and Human ServicesDrug, alcohol, tobacco useDrug safety, medical device, and laboratory regulation
To amend section 505(c)(3)(E) of the Federal Food, Drug, and Cosmetic Act to prevent certain applications from being considered ineligible for approval under section 505(c) of such Act on the basis that the proposed labeling includes information describing abuse-deterrent properties that otherwise would be blocked by exclusivity under clause (iii) or (iv) of section 503(c)(3)(E) of such Act, and for other purposes.
USA115th CongressHR-2025| House
| Updated: 4/7/2017
Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to prevent an application for a new drug from being considered ineligible for approval because its labeling includes information describing abuse-deterrent properties that otherwise would be blocked by market exclusivity provisions. The Department of Health and Human Services shall issue draft guidance and publish final guidance regarding the award and scope of exclusivity for new drugs with properties designed to deter abuse and the exceptions to such exclusivity. The bill applies to applications and supplements to applications that are submitted or pending approval on or after January 1, 2017.
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Timeline
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
H. Morgan Griffith
Republican Representative
Virginia
Cosponsors (1)
Health Subcommittee, Energy and Commerce Committee
Health
- Introduced
- In Committee
- On Floor
- Passed Chamber
- Enacted
Administrative law and regulatory proceduresDepartment of Health and Human ServicesDrug, alcohol, tobacco useDrug safety, medical device, and laboratory regulation