About HR2430

FDA Reauthorization Act of 2017

Policy Area: Health

Sponsor: Rep. Walden, Greg [R-OR-2] (R-OR)

Latest Action (2017-08-18): Became Public Law No: 115-52.

Summary

(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 int

Subjects: Administrative law and regulatory procedures, Cancer, Child health, Congressional oversight, Department of Health and Human Services, Drug safety, medical device, and laboratory regulation, Drug therapy, Executive agency funding and structure

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