H.R. 3497 (112th): MODDERN Cures Act of 2011

Introduced:
Nov 18, 2011 (112th Congress, 2011–2013)
Sponsor:
Rep. Leonard Lance [R-NJ7]
Status:
Died (Referred to Committee)

The bill’s title was written by the bill’s sponsor. H.R. stands for House of Representatives bill.

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Status

This bill was introduced on November 18, 2011, in a previous session of Congress, but was not enacted.

Progress
Introduced Nov 18, 2011
Referred to Committee Nov 18, 2011
Cosponsors
48 cosponsors (25D, 23R) (show)
Committees

House Energy and Commerce

House Judiciary

House Ways and Means

The committee chair determines whether a bill will move past the committee stage.

Full Title

To promote the development of meaningful treatments for patients.

Summary

No summaries available.

Text

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Last updated Nov 18, 2011.
33 pages

Primary Source

View on THOMAS (The Library of Congress)

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Citation

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GovTrack’s Bill Summary

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Library of Congress Summary

The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.

11/18/2011--Introduced.
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.

House Republican Conference Summary

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No summary available.

House Democratic Caucus Summary

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The bill contains the following citations to other parts of U.S. law:

United States Code

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