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

FDA BLUE RIBBON COMMISSION: DESPERATELY SEEKING CHAIRMAN

Executive Summary

FDA BLUE RIBBON COMMISSION: DESPERATELY SEEKING CHAIRMAN as at least one choice has recently declined the position. While HHS had expected to announce the members of the panel in January, the department has still not decided on a chairman, which is holding up appointment of the other panel members. HHS Secretary Sullivan on Dec. 12 announced formation of the panel to "examine the mission, responsibilities and structure of the FDA in order to make recommendations on how the FDA can be strengthened to benefit the public health" ("The Pink Sheet" Dec. 18, p. 4). Donald Rumsfeld, the former Nixon/Ford senior government official and chairman/CEO of Searle, was the latest candidate reported to have been under consideration for the chairmanship. However, Rumsfeld says he will not participate in the advisory group. Rumsfeld is a senior advisor to the William Blair & Co. investment firm. Rumsfeld reportedly met with Sullivan at one point to discuss the position. As with any special commission, HHS may be having trouble convincing prospective chairmen of the ultimate effectiveness of the advisory group and more specifically, of the extent of HHS' commitment to the group. Selection of a well-known political figure -- like a former Secretary of Defense -- to head the panel, would also raise the issue of how much latitude the chairman should have in selecting panel members. Names circulating as prospective panel members include one current drug company exec, Roche President Irwin Lerner. As chairman of a five year-old PMA special board committee on FDA, Lerner has been closely involved in looking at ways of improving agency activities with regard to new drug review. Lerner is also reportedly one of the few industry execs who is favorably inclined toward user fees. Some Washington observers believe that a positive attitude toward user fees is a key quality being looked for in prospective commission members. Another name reportedly under consideration for the panel is former FDA Commissioner Charles Edwards. The president of the Scripps Clinic and Research Foundation was recently approached as a possible interim successor to former FDA Commissioner Young. Former FDA Associate Commissioner for Regulatory Affairs John Taylor, who retired from the agency in July, has also been mentioned as a candidate. Other names that have been circulating include: former HHS Senior Health Policy Advisor Jane Delgado, now president of the National Coalition of Hispanic Health and Human Services; Bruce Silverglade, director of the Center for Science in the Public Interest; former Health Industry Manufacturers Association President Frank Samuel; and David Kessler, medical director of the Jack D. Weiler Hospital of the Albert Einstein School of Medicine and former staffer to Sen. Hatch (R-Utah), from 1981 to 1984.

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

OM013164

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