To amend chapter V of the Federal Food, Drug, and Cosmetic Act to expedite the development and review of breakthrough therapies.
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.
Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS), at the request of the sponsor of a drug, to expedite the drug's development and review if: (1) it is intended, either alone or in combination, to treat a serious life-threatening disease or condition; and (2) preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.
Authorizes the drug's sponsor to request the Secretary to designate the drug as a breakthrough therapy. Requires the Secretary, within 60 days of such request, to determine whether the drug meets such criteria and, if so, make such designation, followed by appropriate actions to expedite its development and review for approval.
Requires an annual report from the Secretary to Congress on drugs for which breakthrough designations were requested and approved.
Directs the Secretary to issue guidance on implementing requirements with respect to breakthrough therapies and to amend promulgated regulations.
Requires the Comptroller General to assess the manner by which the Food and Drug Administration (FDA) has applied the processes established by this Act and their impact on the development and timely availability of innovative treatments for patients affected by serious or life-threatening conditions.
Written by analysts at the Congressional Research Service and published on Congress.gov, not by Civibrief. Summarized at the "Introduced in House" stage on May 7, 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 May 11, 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 May 7, 2012, and 1 member has since signed on as a cosponsor.
They are 1 Democrat.
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 May 7, 2012, 5239 days ago. The most recent recorded action was 5235 days ago, on May 11, 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