Tax News Update    Email this document    Print this document  

April 28, 2022
2022-0689

Senate HELP hearing on FDA user fee agreements | Advancing medical product regulation and innovation for the benefit of patients, FDA Center Directors

On April 26, the Senate Health, Education, Labor & Pensions (HELP) Committee held a hearing entitled, "FDA User Fee Agreements: Advancing Medical Product Regulation and Innovation for the Benefit of Patients, FDA Center Directors." The hearing was the second of two the committee has held on Food and Drug Administration (FDA) user fee agreements, which authorize the FDA to collect user fees from drug and device manufacturers and requires congressional reauthorization every five years.

During the hearing, committee members discussed a range of topics related to the Prescription Drug User Fee Amendments (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), Biosimilar User Fee Amendments (BsUFA III), and the Medical Device User Fee Amendments (MDUFA V), which would authorize new user fees for their respective industries for fiscal years 2023–2027. Witnesses at Tuesday's hearings included representatives from the FDA who answered questions on ways the latest agreements would improve FDA's ability to provide access to safe and effective drugs and medical devices, as well as related topics.

More information is available here.

Additional information is also available in the attached Tax Alert.

———————————————

Contact Information
For additional information concerning this Alert, please contact:
 
Washington Council Ernst & Young
   • Heather Meade (heather.meade@ey.com)
   • Heather Bell (heather.bell@ey.com)

———————————————
ATTACHMENT

Senate HELP hearing on FDA user fee agreements

 

The information contained herein is general in nature and is not intended, and should not be construed, as legal, accounting or tax advice or opinion provided by Ernst & Young LLP to the reader. The reader also is cautioned that this material may not be applicable to, or suitable for, the reader's specific circumstances or needs, and may require consideration of non-tax and other tax factors if any action is to be contemplated. The reader should contact his or her Ernst & Young LLP or other tax professional prior to taking any action based upon this information. Ernst & Young LLP assumes no obligation to inform the reader of any changes in tax laws or other factors that could affect the information contained herein.

 

Copyright © 1996 – 2024, Ernst & Young LLP

 

All rights reserved. No part of this document may be reproduced, retransmitted or otherwise redistributed in any form or by any means, electronic or mechanical, including by photocopying, facsimile transmission, recording, rekeying, or using any information storage and retrieval system, without written permission from Ernst & Young LLP.

 

EY US Tax News Update Master Agreement | EY Privacy Statement