Bill Sponsor
Senate Bill 934
115th Congress(2017-2018)
FDA Reauthorization Act of 2017
Introduced
Introduced
Introduced in Senate on Apr 25, 2017
Overview
Text
Introduced
Apr 25, 2017
Latest Action
May 11, 2017
Origin Chamber
Senate
Type
Bill
Bill
The primary form of legislative measure used to propose law. Depending on the chamber of origin, bills begin with a designation of either H.R. or S. Joint resolution is another form of legislative measure used to propose law.
Bill Number
934
Congress
115
Policy Area
Health
Health
Primary focus of measure is science or practice of the diagnosis, treatment, and prevention of disease; health services administration and funding, including such programs as Medicare and Medicaid; health personnel and medical education; drug use and safety; health care coverage and insurance; health facilities. Measures concerning controlled substances and drug trafficking may fall under Crime and Law Enforcement policy area.
Sponsorship by Party
Republican
Tennessee
Democrat
Washington
Senate Votes (0)
House Votes (0)
No Senate votes have been held for this bill.
Summary

FDA Reauthorization Act of 2017

Prescription Drug User Fee Amendments of 2017

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.

Medical Device User Fee Amendments of 2017

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.

The FDA must establish a pilot program to accredit testing laboratories to determine whether medical devices conform to performance standards.

The bill revises the types of medical devices that the FDA may accredit third parties to review.

Generic Drug User Fee Amendments of 2017

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.

Biosimilar User Fee Amendments of 2017

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.

The bill extends through FY2022 programs and policies including Critical Path Public-Private Partnerships and support for development of medical products for rare conditions.
Text (2)
May 11, 2017
April 25, 2017
Actions (5)
05/11/2017
Placed on Senate Legislative Calendar under General Orders. Calendar No. 76.
05/11/2017
Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
05/11/2017
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
04/25/2017
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
04/25/2017
Introduced in Senate
Public Record
Record Updated
Jan 11, 2023 1:36:21 PM