Food and Drug Administration Reform Act of 2012
Latest action. Received in the Senate. Read twice. Placed on Senate legislative calendarThe list of measures reported out of committee and eligible for floor action. Being on the calendar is not a promise of a vote.Read the full definition (opens a new tab) under General Orders. Calendar No. 420.
Food and Drug Administration Reform Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to reauthorize and establish new Food and Drug Administration (FDA) prescription drug user-fee programs and to revise and impose new requirements relating to: (1) prescription, pediatric, and generic drugs; (2) medical devices; (3) biosimilar biological products; and (4) registration of drug manufacturers and reporting of drug shortages.
Title I: Fees Relating to Drugs - Prescription Drug User Fee Amendments of 2012 - (Sec. 103) Extends through FY2017 the authority of the Secretary of Health and Human Services (HHS) to assess and collect human drug application and supplement fees, prescription drug establishment fees, and prescription drug product fees to support the FDA drug development process and the process for the review of human drug applications. Increases for FY2013-FY2017 the level of required prescription drug user fee revenues. Provides for an inflation adjustment and a workload adjustment for FY2013 and subsequent fiscal years for the required level of user fee revenue amounts.
(Sec. 104) Requires the Secretary to submit to the House Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor, and Pensions (the specified congressional committees) after the end of each fiscal year for which user fees are collected under this title (beginning with FY2013) a report on the progress of the FDA in achieving the goals identified in the letters sent by the Secretary to the Committees, the future plans of the FDA, and the progress of the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research in achieving such goals.
(Sec. 105) Terminates: (1) the authority of the Secretary to assess and collect prescription drug user fees on October 1, 2017, and (2) reporting requirements on January 31, 2018.
(Sec. 106) Provides that the amendments made by this title shall take effect on the later of October 1, 2012, or the enactment date of this Act, except that user fees shall be assessed for all human drug applications received on or after October 1, 2012, regardless of the enactment date of this Act.
The summary continues for 93 more paragraphs. Read it in full on Congress.gov
Written by analysts at the Congressional Research Service and published on Congress.gov, not by Civibrief. Summarized at the "Passed House amended" stage on May 30, 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 June 4, 2012: Received in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 420.
- 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?
FRED UPTON (R-MI) introduced it on May 9, 2012, and 5 members have since signed on as cosponsors.
They come from both major parties: 3 Democrats, 2 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 May 9, 2012, 5284 days ago. The most recent recorded action was 5258 days ago, on June 4, 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