Generics Bulletin is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

White House Slams Generic Exclusivity Provisions In User Fee Bill

Executive Summary

Trump administration says generic exclusivity provisions – which have been softened from the original bill – are unpredictable and could decrease competition; and while the White House is displeased with exclusivity, and wants higher user fees, it is not explicitly threatening a veto.

You may also be interested in...



US FDA 'Medical Innovation Development Plan' Outlined By Gottlieb

Testifying before Senate subcommittee, FDA commissioner put his plans for facilitating new drug development front and center, a shift from his many past discussions about generic drug development.

Breakthrough-Style Program For ANDAs Added To House User Fee Bill

Energy and Commerce subcommittee unanimously advances reauthorization legislation with four added amendments, including one that would allow for certain generic sponsors to meet early and often with FDA to speed development.

Trump's Budget Outline Threatens User Fee Agreements

President wants substantially more user fee revenue than negotiated in user fee agreements, and some in industry already are warning that requiring increases now could endanger program reauthorizations.

Topics

UsernamePublicRestriction

Register

GB002135

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel