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



Executive Summary

FDA "EXTERNAL REVIEW" PROGRAM DELAY WILL BE RECOMMENDED by the House Government Operations/Human Resources Subcommittee in an investigative report on the activities of Vice President Quayle's Council on Competitiveness. The report, entitled "The Quayle Council's Plans for Changing FDA's Drug Approval Process: A Prescription for Harm," was approved by the full Government Operations Committee on Oct. 1 by a vote of 24-14. The report will be released once minority staff have had the opportunity to review the report and comment on the findings and recommendations. In a statement entered into the record of the Oct. 1 committee meeting, Human Resources and Intergovernmental Relations Subcommittee Acting Chairman Payne (D-N.J.) said the report's recommendations will include "halting all activities related to implementation" of the council's proposal that FDA consider contracting out NDA reviews "until the public has had an adequate opportunity to comment on the plan." FDA is slowly implementing a pilot program that will look at efficacy supplements to test the viability of outside reviews; since April the agency has been in negotiations with its first potential outside contractor, Mitre Corp. ("The Pink Sheet" July 27, p. 7). Payne said the report found that the Competitiveness Council's external review recommendation "is designed to prevent FDA from scrutinizing safety and efficacy data." Payne was appointed the acting chairman of the subcommittee following the death of Rep. Weiss (D-N.Y.) on Sept. 14 ("The Pink Sheet" Sept. 21, T&G-8). The report will be one of Rep. Weiss' final legacies as chairman of the oversight subcommittee. The Council on Competitiveness had been a favorite target of Weiss' during the past session of Congress and the posthumous release of the report will allow one last jab at the council, questioning the legality of its mandate and recommending the enactment of the so-called "Regulatory Sunshine Act," HR 5702. The report also found that the council's recommendation to transfer IND approvals to institutional review boards "will subject human volunteers to untested drugs based upon a review by unqualified outside groups," Payne said. He maintained that Lilly "openly defied FDA by attempting to file an application with an IRB rather than with FDA." The report will also question FDA's adoption of the accelerated approval plan, which, "if fully implemented, will force FDA to approve drugs for any condition -- not just life-threatening illnesses -- based on only preliminary evidence of safety and efficacy," Payne stated. Payne indicated that the report also will take FDA Commissioner Kessler to task for his testimony before the subcommittee in March ("The Pink Sheet" March 23, p. 3). "The report finds that FDA is implementing the Quayle council reforms despite the agency's disagreement with the basic premise of the council's recommendations that millions of lives and billions of dollars will be saved," Payne declared. "According to the report," he added, "Commissioner Kessler's attempt at the hearing to disavow his own criticisms of the 'external review' proposals was at best disingenuous and at worst a deliberate effort to mislead the subcommittee and the public." In addition, the report will point out that other FDA staff "are concerned" about several of the council recommendations, Payne said. At the March hearing, Weiss cited memos from several FDA senior staff members, including ODE I Director Robert Temple and Chief Counsel Margaret Porter, questioning expansion of the "accelerated approval" proposal to drugs for chronic illnesses. The Government Operations Commitee approved five other human resources subcommittee reports on Oct. 1 by unanimous consent. The other reports cover off-label device and drug uses, focusing on Retin-A; the politics of AIDS prevention; technology transfer from universities to industry; V-A medical quality assurance programs; and the head injury rehabilitation industry. The reports may become available during the week of Oct. 5-9.

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




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