MODDERN Cures Act of 2011

Bill: 112-hr-3497
Sponsor: Rep. Lance, Leonard [R-NJ-7]
Introduced: 2011-11-18 in the House
Policy area: Health
Subjects: 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

Summary:
action_date: 2011-11-18
text: 
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.


Legislative actions:
action_date: 2011-12-02
text: Referred to the Subcommittee on Intellectual Property, Competition and the Internet.
action_date: 2011-11-22
text: Referred to the Subcommittee on Health.
action_date: 2011-11-18
text: Referred to the Subcommittee on Health.
action_date: 2011-11-18
text: 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.
action_date: 2011-11-18
text: 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.
action_date: 2011-11-18
text: 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.
action_date: 2011-11-18
text: Introduced in House
action_date: 2011-11-18
text: Introduced in House