H.R. 3497112th CongressHouse Bill

MODDERN Cures Act of 2011

Introduced in the HouseDead

This bill died when its Congress ended.

Bills don't carry over between Congresses. Without re-introduction in a new session, it cannot advance.

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.

Introduced Nov 18, 2011
1
Introduced

Filed in the House

2
Passed House
3
Passed Senate
4
Became Law

This house bill has been filed and is working its way through Congress. It will need to pass both the House and the Senate, then be signed by the President to become law.

Who introduced this

LL

Leonard Lance

Republican

U.S. Representative · NJ-7

Bipartisan — 48 cosponsors (25 D, 23 R)

Ask AI About This Bill

Get plain-language answers with direct quotes from the bill text.

to ask questions about this bill.

Your Representatives

Enter your address to see how your representatives voted on this bill.

Your address is only used to find your district and is never saved. See how it works

Votes

Public Opinion

No votes yet — be the first to weigh in.

to cast your vote

Your voice matters — let representatives know where you stand.

Comments

No comments yet. to be the first to weigh in.