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. MAY PARTICIPATE IN FDA’s PILOT PROGRAM FOR EXTERNAL REVIEWS

Executive Summary

The federally-capitalized MITRE Corp. may participate in FDA's pilot program for external reviews of NDAs and PLAs, according to an April 1 notice in the Commerce Business Daily. FDA said in the notice that it "has a requirement for a pilot program to conduct complete and/or partial external reviews" of NDAs and PLAs. It "intends to procure these services from the MITRE Corporation," the notice says. MITRE is a non-profit firm based in Bedford, Mass. that does not have to bid for certain government contracts. MITRE has annual revenues of about $500 mil. from its contracts with the Defense, NASA, FAA and other government agencies. FDA and MITRE are apparently still exploring whether the firm will be capable of and interested in conducting the reviews. Regardless of whether MITRE receives a contract, the agency will look for other participants for the pilot program as well, FDA said. On April 3, FDA published a solicitation for information about other firms interested in conducting external reviews. Interested firms are asked to provide: (1) "identification... of key staff to be involved"; (2) "methods to insulate involved contractor staff from conflicts of interest"; and (3) "capability to undertake complete or partial multidisciplined NDA and PLA reviews." The notice states that "responses will not be considered as either bids or proposals; cost or pricing data need not be submitted. All qualified sources will be solicited" when FDA is prepared to accept bids. The closing date for responses is 60 days after publication, or June 3. Vice-President Quayle's Council on Competitiveness issued the external review proposal in November ("The Pink Sheet" Nov. 18, 1991, p. 3). At an April 9 press conference, Quayle, FDA, and HHS announced the progress on this and other Competitiveness Council proposals (see related stories). The external review program appears to be slightly behind schedule: in November, FDA proposed to begin external review of the first four applications by this May. Quayle stressed at the press conference that FDA would make the "final determination" on approving externally reviewed applications. However, Rep. Weiss (D-N.Y.) continued to criticize the external review concept. In an April 9 statement, Weiss said the proposal "may jeopardize public health if, as originally designed by the Quayle Council, FDA would be prevented from scrutinizing safety data."

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

ID007083

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