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

UsernamePublicRestriction
UsernamePublicRestriction

FDA ADVISORY COMMITTEE VACANCY RATE IS ROUGHLY 7%

Executive Summary

FDA ADVISORY COMMITTEE VACANCY RATE IS ROUGHLY 7%, down from about 25% in 1983, FDA Office of Scientific Advisors and Consultants Deputy Director Jack Gertzog reported Sept. 15 to the 11th annual meeting of the Regulatory Affairs Professional Society. Since its establishment in 1983, the office of scientific advisors and consultants "has substantially improved the committee process," Gertzog stated. In addition to a decreased vacancy rate, "[w]e have expanded our efforts to contact professional organizations and academia to obtain more and better nominations," Gertzog said. Noting the difficulty of recruiting good members, Gertzog explained that FDA competes for those members with "industry, NIH, professional societies, editorial boards, and with other full-time teaching, research, and clinical responsibilities." Gertzog noted that "[a]t least one committee has not met in over two years." Others have not met in well over a year, he added, while the average committee meets one and a half times per year. In a separate presentation FDA Division of Management Systems and Policy Review Director Robert Bell, told RAPS members that one obstacle in attracting top-notch advisory members is FDA's $100 per diem compensation. "When they can go out and get $1,000 a day for consultancy, it's awfully hard to entice them to come to Washington," Bell said. He also said he is trying to raise the salary level to $256 per day. "I'm not getting a whole lot of support for that outside of the Food and Drug Administration."

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

UsernamePublicRestriction

Register

LL1135544

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

Cancel