MODDERN Cures Act of 2011
Bill journey · stage 2 of 5
Under committee review
What it doesSummary introduced in house (Nov 18, 2011)
Modernizing Our Drug & Diagnostics Evaluation and Regulatory Network Cures Act of 2011 or the MODDERN Cures Act of 2011 - Requires the Secretary of Health and Human Services (HHS) to: (1) establish the Advanced Diagnostics Education Council to recommend standard terms and definitions related to innovative diagnostics for use by patients, physicians, health care providers, payers, and policy makers.; and (2) publish a guide regarding such terms and definitions.
Sets forth additional factors for the Secretary to consider in determining the payment amount for new clinical diagnostic laboratory tests under gap filling procedures which are used when no comparable existing test is available.
Extends the exclusivity period for a drug or biological product if the diagnostic test related to such drug has been determined by the Secretary to have been developed by, or with the participation of, the manufacturer or sponsor of the drug or biological product, and use of the diagnostic tests provides for or improves: (1) the identification of a patient population for the drug or biological product; or (2) the determination of the most appropriate treatment option for a patient population with the drug or biological product.
Establishes a dormant therapy designation for drugs or biological products that address unmet medical needs. Gives such a drug or biological product 15 years of data exclusivity under which no drug can be approved by relying on the approval or licensure of the dormant therapy.
What just happenedDec 2, 2011
Referred to the Subcommittee on Intellectual Property, Competition and the Internet.
Who’s behind it
- Introduced in HouseNov 18, 2011
- Dec 2, 2011CommitteeH11000
Referred to the Subcommittee on Intellectual Property, Competition and the Internet.
Over-Criminalization Task Force Subcommittee - Nov 22, 2011CommitteeH11000
Referred to the Subcommittee on Health.
Health Subcommittee - Nov 18, 2011CommitteeH11000
Referred to the Subcommittee on Health.
Health Subcommittee - Nov 18, 2011IntroReferralH11100
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Judiciary Committee - Nov 18, 2011IntroReferralH11100
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Ways and Means Committee - Nov 18, 2011IntroReferralH11100
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Energy and Commerce Committee - Nov 18, 2011IntroReferralIntro-H
Introduced in House
- Nov 18, 2011IntroReferral1000
Introduced in House