ACCESS Act
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.
Access, Compassion, Care, and Ethics for Seriously Ill Patients Act or the ACCESS Act - Amends the Federal Food, Drug, and Cosmetic Act to replace the current fast track product approval process with a multi-tiered approval process for any investigational drug, biological product, or device. Provides for expedited approval for a drug, biological product, or device for a serious or life-threatening condition, with additional conditions such as additional studies, limits on advertising and promotional materials, and expedited withdrawal procedures.
Requires the Secretary of Health and Human Services to: (1) establish the Accelerated Approval Advisory Committee to issue recommendations to the Secretary on applications submitted by a sponsor of such a drug, product, or device; (2) prohibit placebo-only or no-treat-only concurrent controls in clinical investigations with respect to any life-threatening condition or disease where reasonably effective, approved, alternative therapies exist for the specific indication; (3) establish a program to encourage the development of surrogate endpoints and biomarkers that are reasonably likely to predict clinical benefit for serious or life-threatening conditions for which there exist significant unmet medical needs; (4) request that the Institute of Medicine undertake a study to identify validated surrogate endpoints and biomarkers, and recommend research to validate surrogate endpoints and biomarkers, that may support approvals for products intended for the treatment of serious or life-threatening conditions or diseases; and (5) give equal weight to clinical judgment and statistical analysis in the evaluation of the safety and effectiveness of new products and not disapprove a product application solely on the basis of a statistical analysis or the rigid use of the 95% confidence level convention.
Requires the Food and Drug Administration (FDA) to establish a new program to expand access to investigation treatments for individuals with serious or life-threatening conditions and diseases.
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 29, 2006. 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 October 2, 2006: 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 109th Congress (2005-06), 482 of the 10,701 bills and joint resolutions introduced became law, about 4.5 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?
CHRISTOPHER SHAYS (R-CT) introduced it on September 29, 2006. No cosponsors are recorded.
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 29, 2006, 7286 days ago. The most recent recorded action was 7283 days ago, on October 2, 2006.
Measures do not carry over. Anything the 109th Congress has not finished by January 3, 2007 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