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

USER FEES "ARE COMING," SEN. HATCH's AIDE PREDICTS at a March 12 session of the Health Industry Manufacturers Association annual meeting in Naples, Florida. "I think user fees are coming," said Nancy Taylor, health policy director for Sen. Hatch (R-Utah). "I believe there will be a strong push now that [Rep.] Dingell [D-Mich.] has opened the door to user fees and [Sen.] Kennedy [D-Mass.] has opened the door to user fees, as has [Rep.] Waxman" (D-Calif.). Kennedy, Dingell and Waxman have been opposed to the concept of user fees to supplement FDA appropriations since the Reagan Administration first proposed the idea in the mid-1980s. Taylor's prediction that their acquiescence clears the way for user fees is significant because Hatch has been the last major legislator in the FDA area to hold out against the concept. The Senate staffer indicated that the challenge for the health-related industries will be to "help devise a way [to implement user fees that] won't harm your industry to such an extent that it will burden innovation." Her comments were echoed by Jeff Anders, staffer to Sen. Dodd (D-Conn.). "I sense there is a weakening in the resolve" to oppose user fees, Anders said. "I'm not endorsing them necessarily, but I think it is something we are going to have to be concerned with." He added that if they are instituted in a way that assures funds raised are "dedicated totally to product review, to getting products on the market faster, in the long run it's probably better economically for the companies involved." Taylor also said user fee authorization legislation could have made greater progress last year had the concept been proposed differently in the Senate Labor & Human Resources Committee. Anders noted that the idea of a registration fee as an alternative to user fees surfaced last year, but died in committee. Taylor replied that the "primary reason" the committee did not move the proposal was that Chairman Kennedy planned to use revenues from user fees for budget reduction rather than increasing FDA funds. "If it had been dedicated to FDA exclusively," she said, "I think it would have passed the committee." On the House side, although Health Subcommittee Chairman Waxman (D-Calif.) has not favored user fees in the past, former aide Peter Budetti, MD, acknowledged: "We are concerned about [FDA] resources. We don't look entirely to user fees by any means, but I think that's something everyone has to consider." Waxman disclosed his openness to the concept last month ("The Pink Sheet" Feb. 12, T&G-1).

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

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