ULTRA
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Unlocking Lifesaving Treatments for Rare-Diseases Act or ULTRA - Amends the Federal Food, Drug, and Cosmetic Act to authorize the Secretary of Health and Human Services (HHS) to approve an application for a drug as a fast track product using a surrogate endpoint, based on the existence of reasonable scientific data that support and qualify the relevance of such endpoint to the disease state and treatment, if the Secretary: (1) makes an initial determination that the drug is eligible for approval as a drug designated for a rare disease or condition (orphan drug) and as a fast track product, and (2) determines that the drug is a treatment for a disease or condition that affects a small number of patients in the United States. Prohibits the Secretary from requiring clinical treatment or other historical clinical data on such endpoint as a prerequisite to assessment of that endpoint if such scientific data is not available.
Directs the Secretary to issue guidance providing details and options for qualifying surrogate endpoints without clinical data, taking into account and balancing: (1) the unmet need served by the drug and the adverse effects of the rare disease or condition on quality and length of life, (2) the very low likelihood that clinical data would exist or that clinical studies would be completed to support a surrogate endpoint due to the small size of the U.S. patient population and other significant barriers inherent in performing such studies due to the prevalence of the disease or related factors, and (3) the full scope of available basic scientific data and information that the Secretary deems reasonably predictive of a clinical benefit in the absence of clinical data.
Written by analysts at the Congressional Research Service and published on Congress.gov, not by Civibrief. Summarized at the "Introduced in House" stage on December 20, 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 23, 2011: 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?
CLIFF STEARNS (R-FL) introduced it on December 20, 2011, and 13 members have since signed on as cosponsors.
They come from both major parties: 5 Democrats, 8 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 December 20, 2011, 5425 days ago. The most recent recorded action was 5422 days ago, on December 23, 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