MODDERN Cures Act of 2013

Summary

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.

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Timeline

1. 12 September 2013

   Introduced

   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.

   Source: IntroReferral

2. 12 September 2013

   Introduced

   Introduced in House

   Source: IntroReferral

3. 12 September 2013

   Introduced

   Introduced in House

   Source: IntroReferral

4. 13 September 2013

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

5. 15 October 2013

   Referred

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

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in House · 12 September 2013 · Official file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 12 September 2013

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 12 September 2013

  ViewDownloadOpen at official source

• Introduced in House

  summary · EN · 12 September 2013

  Open at official source

Sponsors

• Leonard Lance · R · Sponsor
• Peter Roskam · R · Sponsor
• Brett Guthrie · R · Sponsor
• Erik Paulsen · R · Sponsor
• Rep. Rangel, Charles B. [D-NY-19] · D · Sponsor
• Rep. Runyan, Jon [R-NJ-3] · R · Sponsor
• Rep. Schwartz, Allyson Y. [D-PA-13] · D · Sponsor
• PETER KING · R · Sponsor
• Rep. McCaul, Michael T. [R-TX-10] · R · Sponsor
• GREG WALDEN · R · Sponsor
• PATRICK TIBERI · R · Sponsor
• David Loebsack · D · Sponsor
• Sen. Luján, Ben Ray [D-NM] · D · Sponsor
• Keith Ellison · D · Sponsor
• WALTER JONES · R · Sponsor
• Billy Long · R · Sponsor
• Vern Buchanan · R · Cosponsor
• · hsju00 · Standing
• · hsif00 · Standing
• · hswm00 · Standing

Related records

• related to → Diagnostic Innovation Testing and Knowledge Advancement Act of 2013
• related to ← MODDERN Cures Act of 2013