FDA Reauthorization Act of 2017
Latest action. Became public lawWhat a bill becomes when enacted, numbered by Congress and order of enactment: Public Law 119-4 is the 4th law of the 119th Congress.Read the full definition (opens a new tab) No: 115-52.
(This measure has not been amended since it was passed by the House on July 12, 2017. The summary of that version is repeated here.)
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 brand name drugs. User fees are eliminated for supplemental new drug applications and drug manufacturing facilities.
A prescription drug program fee replaces the prescription drug product fee. This annual fee is assessed on a new drug application holder for each approved drug for up to five drugs.
The total user fee revenue amount is adjusted annually for changes in review process capacity needs, to provide for operational reserves, and for additional direct costs. Eighty percent of revenues must be generated by prescription drug program fees, with the remainder from application fees.
(Sec. 103) The bill extends through FY2022 requirements for annual reports and consultation by the FDA on reauthorization of brand name drug user fees.
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’s authority to waive or reduce device user fees in the interest of public health is eliminated.
(Sec. 204) The bill extends through FY2022 requirements for annual reports and consultation by the FDA on reauthorization of user fees for medical devices.
(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 extends through FY2022 the FDA's authority to accredit third parties to review premarket notifications for medical devices. The bill revises the types of devices that third parties may review.
The summary continues for 78 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 "Public Law" stage on August 18, 2017. It describes the bill, it is not the legal text.
Where is it in the process, and what happens next?
This bill has been enacted. It is law.
The record's latest action, on August 18, 2017: Became Public Law No: 115-52.
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?
GREG WALDEN (R-OR) introduced it on May 16, 2017, and 3 members have since signed on as cosponsors.
They come from both major parties: 2 Democrats, 1 Republican.
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.
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
- HousePassed
- SenatePassed
- PresidentSigned into law