In the journal, Nature, there are a group of letters from renowned scientists and policy makers to President Obama from Christine Todd Whitman, former Governor of New Jersey and Administrator of the Environmental Protection Agency (EPA) on environmental issues to Steve Nissen, M.D. on reforming the FDA.
Dr. Nissen, Chairman of the Department of Medicine at the Cleveland Clinic and perennial candidate for FDA Commissioner, says that “An end to secrecy will revive the FDA” (his article is 3/5ths down the link).
Dr. Nissan’s suggestions include:
· Commissioner should serve a fixed six-year term to insulate the agency from political influence;
· The Agency must cease to regard clinical-trial data as proprietary and provide access to all available information on safety and efficacy;
· The Agency needs better harmonization between its Office of Surveillance and Epidemiology, which monitors post-marketing safety, and its Office of New Drugs, which is responsible for post-marketing regulatory decisions;
· Partner with Health Maintenance Organizations (HMOs) and other large healthcare providers to collect adverse event reports;
· For approval of pharmaceuticals, decrease the reliance on non-inferiority and bio markers trials;
· For approval of devices, reduce the reliance on ‘substantially equivalent’ trials;
· The right to restrict direct-to-consumer advertising for the first two years after approval;
· Stop off-label promotion through dissemination of journal reprints;
· Increase inspection of foreign facilities; and
· Increase by a multiple of four the FDA’s $2.3 billion budget.
Nature, January 15, 2009 An End to Secrecy Will Revive the FDA.