MODDERN Cures Act of 2013

Bill: 113-hr-3116
Sponsor: Rep. Lance, Leonard [R-NJ-7]
Introduced: 2013-09-17 in the House
Policy area: Health
Subjects: Administrative law and regulatory procedures
Administrative remedies
Advisory bodies
Department of Health and Human Services
Drug safety, medical device, and laboratory regulation
Drug therapy
Executive agency funding and structure
Food and Drug Administration (FDA)
Government studies and investigations
Intellectual property
Medical research
Medical tests and diagnostic methods
Medicare
Prescription drugs

Summary:
action_date: 2013-09-17
text: 
Modernizing Our Drug & Diagnostics Evaluation and Regulatory Network Cures Act of 2013 or MODDERN Cures Act of 2013 - 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 medicine 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 medicine, and use of the diagnostic tests provides for or improves: (1) the identification of a patient population for the medicine; or (2) the determination of the most appropriate treatment option for a patient population with the medicine. 
 
Establishes a dormant therapy designation for medicine that addresses unmet medical needs. Gives such medicine 15 years of data exclusivity under which no drug can be approved by relying on the approval or licensure of the dormant therapy.
 
 Directs the Secretary to arrange with the Institute of Medicine (or, if it declines, another appropriate entity) to study intellectual property laws and their impact on therapy and diagnostic development in order to formulate recommendations on how to facilitate the clinical evaluation and development of therapies currently available on the market for new potential indications.

Legislative actions:
action_date: 2014-01-09
text: Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.
action_date: 2013-09-20
text: Referred to the Subcommittee on Health.
action_date: 2013-09-17
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: 2013-09-17
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: 2013-09-17
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: 2013-09-17
text: Introduced in House
action_date: 2013-09-17
text: Introduced in House