MODDERN Cures Act of 2011
Latest action. Referred to the subcommitteeA smaller panel inside a standing committee with jurisdiction over a slice of its subject matter. Most hearings and the first markup usually happen here.Read the full definition (opens a new tab) on Intellectual Property, Competition and the Internet.
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.
Written by analysts at the Congressional Research Service and published on Congress.gov, not by Civibrief. Summarized at the "Introduced in House" stage on November 18, 2011. It describes the bill, it is not the legal text.
Where is it in the process, and what happens next?
4 steps remain before this bill could become law.
The record's latest action, on December 2, 2011: Referred to the Subcommittee on Intellectual Property, Competition and the Internet.
- Clearing the committees it was referred to, and being scheduled for a floor vote
- Passage by the House
- Passage by the Senate
- The President's signature. If the President vetoes it, two-thirds of both chambers must vote to override.
How likely is it to become law?
Civibrief does not forecast outcomes and this page has no opinion about this one. What the record supports is a base rate, which is a fact about the whole pile, not a prediction about this measure.
In the 112th Congress (2011-12), 283 of the 10,618 bills and joint resolutions introduced became law, about 2.7 percent. That count covers every measure at every stage, including the many that never left committee.
This one is not there yet: 4 steps are still outstanding, listed above.
Has anyone actually voted on it?
No. No roll call in this Congress cites this measure. That is the ordinary outcome: most measures never reach a recorded floor vote, and a committee ends most of them simply by not acting.
A vote is not the only thing that happens to a measure. Hearings, markups, and referrals are all recorded actions, and none of them is a vote of the full chamber.
Who is behind it?
Leonard Lance (R-NJ) introduced it on November 18, 2011, and 48 members have since signed on as cosponsors.
They come from both major parties: 25 Democrats, 23 Republicans.
Cosponsoring is a formal signature on the text. It is not a commitment to vote for the measure, it does not bind anyone's party, and a long list of cosponsors is a measure of attention rather than of prospects.
How long has it been in play?
It was introduced on November 18, 2011, 5410 days ago. The most recent recorded action was 5396 days ago, on December 2, 2011.
Measures do not carry over. Anything the 112th Congress has not finished by January 3, 2013 dies when the term ends, and has to be introduced again from the start in the next Congress.
Every answer above is assembled from this measure's own record on Congress.gov and from published counts of what Congress has passed before. Civibrief does not predict outcomes and takes no position on any measure.
Vote history
- HouseIn committee, no floor vote yet
- SenateAwaits House passage
- PresidentAwaits both chambers