Pink Sheet is part of the Business Intelligence Division 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
UsernamePublicRestriction

REP. MADIGAN TO INTRODUCE FDA USER FEE LEGISLATION

Executive Summary

REP. MADIGAN TO INTRODUCE FDA USER FEE LEGISLATION during the week ending May 12 at the request of the Bush Administration. As proposed by the Health and Human Services Department ("The Pink Sheet" April 17, p. 4), the bill will mandate the collection of fees to cover the full cost of processing applications for drugs, biologics, medical devices, foods and color additives. Madigan's bill will embody the HHS proposal. Among other things, the legislation would "credit to the FDA appropriations account that portion of collections based on costs incurred by FDA." The Pharmaceutical Manufacturers Association has continued to express skepticism over whether receipts from user fees would actually be credited to the relevant FDA activities. Madigan's legislation will be referred to the House Energy & Commerce/Health Subcommittee, of which Madigan is the ranking minority member. However, the bill will face substantial resistance from subcommittee Chairman Waxman (D-Calif.), who has publicly opposed user fees. Rep. Dingell (D-Mich.) who chairs the full committee, is also said to be against review charges. HHS is reportedly still looking for a Senate sponsor for its bill.
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS015566

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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