Medtech Insight 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



This article was originally published in The Gray Sheet

Executive Summary

CLINTON ADVISORY COMMITTEE REDUCTION ORDER RESPONSE being formulated by FDA and HHS. In February, President Clinton issued an executive order that requires each department and agency to terminate not less than one-third of its advisory committees. FDA and HHS are considering how FDA's advisory committee system can be downsized. HHS is working under a May 10 deadline to send recommendations to the Office of Management and Budget. The cuts can be made in committees that are subject to the Federal Advisory Committee Act and not required by statute, according to the executive order. Under the order, the cuts are to be made by the end of fiscal year 1993. Each FDA center and office has drawn up a list of options for cuts. The options range from cutting some or all of the committees to combining committees, reducing the number of members and decreasing the frequency of meetings. Another strategy for reducing expenses without cutting the size of committees would have FDA use only government facilities for committee meetings and reduce committee expenses by 5-15%. Ann Witt, special assistant to the Deputy Commissioner for Operations Jane Henney, is coordinating the review for FDA. Witt also is heading up FDA's effort to implement the Institute of Medicine's recommendations for improving FDA's advisory committee process ("The Gray Sheet" Dec. 14, p. 7). The agency has set up working groups, which involve members of committee management in each center, to evaluate the recommendations for possible implementation. FDA hopes that the working groups will make their decisions by the end of 1993 or in early 1994.

You may also be interested in...

Keeping Track: US FDA Clears Esperion’s Nexletol, Baudax’ Anjeso, Agile’s Twirla

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

Esperion’s Nexletol Reaches The Cholesterol Market Priced To Sell

Esperion obtained an on-time approval of Nexletol (bempedoic acid) for a pair of LDL cholesterol-lowering indications on 21 February. 

Pharmacogenetic Tests: US FDA Tries Off-Label Approach To Guide Consumers

US FDA’s latest effort to provide guidance for consumers on pharmacogenomics tests underscores the challenges the agency faces in the absence of a clear regulatory framework for lab-developed tests – and with no easy mechanism to update labels for off-patent drugs.




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