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

WHITE HOUSE BIOTECHNOLOGY COUNCIL WOULD COORDINATE FEDERAL INTERAGENCY ADVICE

Executive Summary

WHITE HOUSE BIOTECHNOLOGY COUNCIL WOULD COORDINATE FEDERAL INTERAGENCY ADVICE on biotechnology policy, under a proposal presented to the NIH Recombinant DNA Advisory Cmte. (RAC) Sept. 23. The concept, developed by the White House Cabinet Council Working Group on Biotechnology, is a modification of an earlier proposal to establish a biotechnology science board within HHS. The White House advisory body would be constituted as a Federal Coordinating Council for Science, Engineering and Technology. It would be one of several "standing" scientific advisory cmtes. currently operating under the aegis of the White House Office on Science and Technology Policy (OSTP). The plan was presented to RAC by Bernadine Healy, outgoing deputy director of OSTP and former chairman of the biotechnology working group. Healy noted that the individual biotechnology proposals would be reviewed by already-established advisory panels, such as RAC and similar groups proposed for FDA, the Environmental Protection Agency, the Department of Agriculture and the National Science Foundation, rather than by the coordinating council. While the locus for the coordinating group would be OSTP rather than HHS, its mandate would be "quite similar" to that initially proposed for the HHS biotechnology board, Healy stated. The HHS science board would have been composed of members from each of the five agencies' advisory panels. The council's functions would include: review of cmte. reports from the five agency biotechnology panels; evaluation of review procedures of agency panels; analysis of broad scientific issues involving DNA, RNA, cell fusion and other processes as needed; development of generic scientific guidelines that can be applied to similar recurring applications; and, providing a forum for public comment. Officially, the group would be chaired by OSTP Director George Keyworth. However, NIH Director Wyngaarden and Natl. Science Foundation Director Erich Bloch would be asked to alternately head the council's activities, Healy said. The proposal is being prepared for publication in the Federal Register, and final White House action is expected in January 1986. RAC unanimously approved a final draft of its "Points to Consider" document for the design and submission of human somatic-cell gene therapy research protocols. The cmte. also agreed to establish a working group to draft language that would broaden the current NIH DNA research guidelines to include experiments involving RNA. The draft language will be published for public comment in the Federal Register at least 30 days prior to RAC's next meeting on Jan. 27.

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

LL1133990

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

Cancel