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HR 3497 112th Congress House Health Administrative law and regulatory procedures Advisory bodies Department of Health and Human Services Drug safety, medical device, and laboratory regulation Drug therapy Executive agency funding and structure Government information and archives Health information and medical records Intellectual property Medical research Medical tests and diagnostic methods Medicare Research and development

MODDERN Cures Act of 2011

Introduced: November 18, 2011 See on congress.gov
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 Everywhere this bill has been 5 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Dec 2, 2011
Referred to the Subcommittee on Intellectual Property, Competition and the Internet.
Nov 22, 2011
Referred to the Subcommittee on Health.
Nov 18, 2011
Referred to the Subcommittee on Health.
Nov 18, 2011
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.
Nov 18, 2011
Introduced in House
 Plain-English summary Congressional Research Service

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's happening now December 2, 2011

Referred to the Subcommittee on Intellectual Property, Competition and the Internet.

 Committees of jurisdiction 6
 Cosponsors 8
All 8 Democratic 6 Republican 2