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

MITRE CORP. WILL REVIEW THREE EFFICACY SUPPLEMENTS

Executive Summary

MITRE CORP. WILL REVIEW THREE EFFICACY SUPPLEMENTS for FDA as the first outside contractor for reviews of drug applications. MITRE Corp., a non-profit firm based in Bedford, Mass., has agreed to undertake the reviews at a cost of $221,608 under a contract signed Sept. 24, FDA said. The funds are from fiscal 1992 appropriations. The federally-capitalized firm is not required to offer competitive bids for certain government contracts. FDA's Center for Drug Evaluation and Research apparently has not decided which three efficacy supplements will be farmed out to MITRE. Some or all of the three supplements reportedly will be for analgesic products. MITRE will be given deadlines for completion of the reviews when FDA hands over the supplements, the agency said. HHS Secretary Sullivan, speaking last November at a press briefing to introduce FDA reforms proposed by Vice President Quayle's Council on Competitiveness, said that contractors would be given a "strict 180-day deadline" for completing the reviews ("The Pink Sheet" Nov. 18, 1991, p. 3). The contractor may not get the supplements until the end of October, FDA said. The external review pilot program is behind schedule. When the proposal was made last November, the agency predicted that it could have the first four applications farmed out to a contractor by May 1992. FDA has been negotiating with MITRE since April ("The Pink Sheet" April 13, p. 14). The outside reviews are being done under a demonstration program to test the feasibility of such reviews as a way of dealing with therapeutic areas that have the greatest backlogs. A report by the House Government Operations/Human Resources Subcommittee on the initiatives proposed by Vice President Quayle's Council on Competitiveness in November 1991 recommends halting implementation of the council's proposal that FDA contract out drug application reviews until the public has an opportunity to comment on the plan (see following T&G). Dissenting views from seven minority members of the Government Operations Committee that accompany the report note that "24 entities have notified FDA of their desire to conduct these reviews."

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

LL1134043

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