Notes on the New FDA Oversight Board and Pending Lester Crawford Nomination
BY JOHN MCCORMICK, FEBRUARY 14, 2005
This morning, newly sworn in House and Human Service Secretary Mike Leavitt announced the creation of a new independent Drug Safety Oversight Board to monitor FDA-approved medicines once they are on the market. The Board will continually update physicians and patients with fresh information on risks and benefits.
The new Board's charter is to improve how new and revised drug safety information reaches patients and doctors. The Board will seek to: (i) resolve disputes over drug safety issues, (ii) recommend what information and updates should be broadly disseminated, and (iii) oversee the development of drug safety policy. The Board will also create a drug safety webpage.
The Drug Safety Oversight Board will be composed of FDA employees, medical experts from other House and Human Service agencies and departments. The Board will also access the expertise and experience of outside medical professionals and consumer and patient groups.
Yesterday, the White House put out a press release stating that President Bush intends to nominate Dr. Lester M. Crawford to be FDA Commissioner. Dr. Crawford has been Acting Commissioner for nearly a year since Mark McClellan left the FDA last March. The announcement was publicly endorsed by Leavitt.
