Pink Sheet 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



Executive Summary

The Health & Human Services Department's proposed legislation for the implementation of user fees at FDA "would credit to the FDA appropriations account that portion of collections based on costs incurred by FDA," the bill states. HHS sent the proposal to Capitol Hill on April 3, but the legislation has not been introduced by a congressional sponsor. The HHS proposal adds parenthetically: "That portion of collections based on costs to the federal government other than FDA would be deposited as miscellaneous receipts of the Treasury." PMA has continued to express skepticism over whether receipts from user fees would actually be credited to relevant FDA activites. Under the proposal, user fee revenues credited to FDA would be available without fiscal year limitation, but subject to "the extent provided in appropriations acts, for FDA's administrative costs connected with carrying out the activities for which the fees were collected." The bill adds that "fees collected for each type of review activity could be used only for costs connected with carrying out that type of activity." User fee charges could be set to cover up to the full cost incurred by the government in processing the request ("The Pink Sheet" March 27, T&G-4). According to the bill, such costs could include: "the conduct of scientific research; development of methods of analysis; purchase of chemicals, fixtures, furniture, and scientific equipment and apparatus; acquisition, maintenance, and repair of real property; and expenses of advisory committees." Charges would be set to cover "costs of review of requests for exemptions with respect to products intended solely for investigational use," HHS Secretary Sullivan said in a cover letter to House Speaker Jim Wright (D-Tex.). "The bill does not require fees for investigational use reviews which do not result in an application for marketing approval," Sullivan added. User fees have been proposed by the Administration four out of the past five years, but have never made it through Congress. This year, user fees have already been opposed by key members including Rep. Waxman (D-Calif.), chairman of the House Energy & Commerce/Health Subcommittee and Sen. Kennedy (D-Mass.), chairman of the Senate Labor & Human Resources Committee. This year's proposal "would become effective upon enactment, but no fees authorized by the bill would be charged until implementing regulations had been promulgated," Sullivan pointed out. FDA Commissioner Young recently expressed concern that the promulgating regulations may not be out in time to meet the federal government's fiscal 1990 budget deadline, thereby leaving FDA with a substantial shortfall in funds ("The Pink Sheet" April 10, p. 3).

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




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