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

Rx-to-OTC switches would be discouraged by the imposition of user fees on new drug applications, Proprietary Association Senior VP and General Counsel Daniel O'Keefe maintains at an April 13 hearing before the House agriculture appropriations subcommittee. "A tax imposed on companies considering use of the NDA system to request FDA to switch a drug from prescription to nonprescription status obviously would discourage that approach by making it more expensive," O'Keefe told the subcommittee. P-A appeared on a panel of four health care industry witnesses. All four, including PMA, the Industrial Biotechnology Association, the Health Industry Manufacturers Association and P-A, strongly opposed the Bush Administration's proposal that $ 100 mil. of the FDA FY 1990 budget be derived from user fees. "Since competition is so keen in the OTC industry," O'Keefe continued, "any additional entry costs in the form of a user fee on a New Drug Application would make it particularly difficult for smaller OTC companies to engage in switch. The result would be an unfair burden on smaller businesses." Industrial Biotechnology Association (IBA) President Richard Godown emphasized the detrimental effect user fees would have on small businesses. "Any proposal to offset budget cuts by adding a user fee would negatively impact on future research and development by increasing new drug development costs," he asserted. At an April 4 Senate Appropriations/Agriculture Subcommittee hearing on the agency's budget, Sen. Bumpers (D-Ark.) noted that he was considering a hearing on the impact of user fees on small businesses. He expressed particular concern for the plight of small medical device manufacturers ("The Pink Sheet" April 10, p. 3). Pharmaceutical Manufacturers Association (PMA) President Mossinghoff opposed user fees, in part, because of the belief that the revenues would not be credited to the relevant operations at the agency affecting the industry paying the fee. Mossinghoff asserted that user fee revenues would not be applied to the relevant FDA programs "even if required authorizing legislation is enacted to permit the crediting of receipts to FDA, rather than allowing the receipts to be deposited in general revenues at the Treasury, as required under federal user-fee policy." The HHS proposed legislation on user fees mandates that at least a portion of user fee revenues collected will be returned to FDA. Rep. Dingell (D-Mich.) appeared later that day to press for more resources at FDA. The chairman of the House Energy & Commerce Committee stated that "I am here because of my deep concern that the current situation at the Food and Drug Administration is untenable. The situation at FDA, if it is allowed to continue, will threaten the health and safety of our citizens and the competitiveness of our producers and pharmaceutical manufacturers.

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