Antibiotic Development to Advance Patient Treatment Act of 2013
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.
Antibiotic Development to Advance Patient Treatment Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to authorize the Secretary of Health and Human Services (HHS) to approve the use of an antibacterial or antifungal drug that is intended for treatment of a serious or life-threatening disease or condition to treat a limited population of patients for which there is an unmet medical need.
Requires the labeling of such drugs to prominently include in the prescribing information the statement that the drug is indicated for use in a limited and specific population of patients.
Amends the Public Health Service Act to authorize the Secretary to license those antibacterial or antifungal drugs as biological products.
Requires the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to: (1) monitor the use of antibacterial and antifungal drugs, (2) monitor changes in bacterial and fungal resistance to drugs, and (3) make the information derived from such monitoring available to the public.
Amends the FFDCA to direct the Secretary: (1) to identify upon approval, and subsequently update, susceptibility test interpretive criteria for antibacterial drugs by relying upon preclinical and clinical data, Bayesian and pharmacometric statistical methodologies, and such other confirmatory evidence the Secretary deems necessary; (2) on a quarterly basis, to evaluate new or updated criteria published by a nationally or internationally recognized standard development organization; and (3) to publish on the Food and Drug Administration's (FDA's) website a notice adopting, declining to adopt, or partially adopting such new or updated criteria.
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 12, 2013. 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 13, 2013: 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 113th Congress (2013-14), 296 of the 9,091 bills and joint resolutions introduced became law, about 3.3 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?
Phil Gingrey (R-GA) introduced it on December 12, 2013, and 52 members have since signed on as cosponsors.
They come from both major parties: 25 Democrats, 27 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 12, 2013, 4655 days ago. The most recent recorded action was 4654 days ago, on December 13, 2013.
Measures do not carry over. Anything the 113th Congress has not finished by January 3, 2015 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