Life-Threatening Diseases Compassion through Combination Therapy Act of 2012
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 Health.
Life-Threatening Diseases Compassion through Combination Therapy Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to authorize the Secretary of Health and Human Services (HHS) to designate a combination of drugs as a significant drug combination if such combination: (1) includes two or more drugs or biological products that, when used in combination, offer the potential to significantly advance treatment for a serious or life-threatening disease and, in combination, meet the criteria for co-development of drug combinations in Food and Drug Administration (FDA) guidance; and (2) includes at least two drugs that are not approved.
Requires the Secretary to develop, publish, and revise annually a list of combinations of two or more drugs designated as significant drug combinations.
Extends the market exclusivity for a drug by six months if it is designated as a significant drug combination before it is approved as a new drug.
Requires the Secretary to review and take action on a drug in a significant drug combination designated under this Act within six months after receiving an application for approval of a new drug application or licensure of a biosimilar biological product.
Requires the Secretary, at the request of the sponsor of a drug, to expedite development and review for designated drug combinations.
Requires the Secretary to establish an interagency task force to encourage the co-development of drugs in significant drug combinations. Requires the task force to develop, revise in response to public comments, and update annually a list of types of drug combinations it recommends that the Secretary designate as significant drug combinations.
Directs the Secretary to study the impact of the extension of market exclusivity under this Act.
Written by analysts at the Congressional Research Service and published on Congress.gov, not by Civibrief. Summarized at the "Introduced in House" stage on September 21, 2012. 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 September 26, 2012: Referred to the Subcommittee on Health.
- 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?
BRIAN BILBRAY (R-CA) introduced it on September 21, 2012, and 2 members have since signed on as cosponsors.
They are 2 Democrats.
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 September 21, 2012, 5102 days ago. The most recent recorded action was 5097 days ago, on September 26, 2012.
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