FDA Reauthorization Act of 2017
Latest action. 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. 76.
FDA Reauthorization Act of 2017
TITLE I--FEES RELATING TO DRUGS
Prescription Drug User Fee Amendments of 2017
(Sec. 102) This bill amends the Federal Food, Drug, and Cosmetic Act to extend through FY2022 and revise Food and Drug Administration (FDA) user fees for new drug applications. User fees are eliminated for supplements to new drug applications and drug manufacturing facilities.
TITLE II--FEES RELATING TO DEVICES
Medical Device User Fee Amendments of 2017
(Sec. 203) The bill extends through FY2022 and revises FDA user fees for medical devices. A user fee is established for requests to classify devices that are not substantially equivalent to marketed devices. The FDA is no longer granted the discretion to waive or reduce fees in the interest of public health.
(Sec. 205) The FDA must establish a pilot program to accredit testing laboratories to determine whether medical devices conform to performance standards.
(Sec. 206) The bill revises the types of medical devices that the FDA may accredit third parties to review.
TITLE III--FEES RELATING TO GENERIC DRUGS
Generic Drug User Fee Amendments of 2017
(Sec. 303) The bill extends through FY2022 and revises FDA user fees for generic drugs. User fees are eliminated for supplements to generic drug applications. An annual fee is assessed on holders of approved generic drug applications.
TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
Biosimilar User Fee Amendments of 2017
(Sec. 403) The bill extends through FY2022 and revises FDA user fees for biosimilars. (Biosimilars are biological products approved by the FDA based on their similarity to an already-approved biological product.) User fees are eliminated for supplements to biosimilar applications and biosimilar manufacturing facilities. An annual fee is assessed on holders of approved applications for biosimilars. The bill sets the annual amount of revenue that must be generated by fees.
TITLE V--PEDIATRIC DRUGS AND DEVICES
(Sec. 501) The bill revises requirements for the FDA to report on pediatric use of medical devices.
The summary continues for 17 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 "Reported to Senate with amendment(s)" stage on May 11, 2017. 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, 2017: Placed on Senate Legislative Calendar under General Orders. Calendar No. 76.
- Clearing the committees it was referred to, and being scheduled for a floor vote
- Passage by the Senate
- Passage by the House
- 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 115th Congress (2017-18), 442 of the 11,421 bills and joint resolutions introduced became law, about 3.9 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?
Lamar Alexander (R-TN) introduced it on April 25, 2017, 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 April 25, 2017, 3425 days ago. The most recent recorded action was 3409 days ago, on May 11, 2017.
Measures do not carry over. Anything the 115th Congress has not finished by January 3, 2019 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
- SenateIn committee, no floor vote yet
- HouseAwaits Senate passage
- PresidentAwaits both chambers