New FDA Leaders Could
Be Tougher on Drug Makers
The Wall Street Journal
NOVEMBER 6, 2008
The Food and Drug Administration has come under fire in the
past year over a host of recalls of tainted produce, unsafe imported foods and
drugs, and brand-name medicines that produced dangerous side effects. Now the
agency will get new leadership that is likely to be tougher on drug makers on a
range of issues from approving new drugs to policing advertising directed at
consumers.
Senate Democrats could seek support from across the aisle to
push several bills opposed by industry, and use hearings and investigations to
shine the spotlight on drug companies and the FDA.
Congress has a lengthy agenda for FDA overhaul. Rep. John
Dingell, chairman of the House Energy and Commerce Committee, has introduced
tough legislation that would add new fees on imports to help pay for more
inspections of foreign country-based plants and incoming drugs and food. Also,
congressional Democrats want to give the FDA oversight of tobacco products. The
bill would create a separate wing at the FDA and set up strict regulations for
A big challenge facing a new FDA administrator will be
rebuilding the agency's staff of scientists. An advisory committee warned this
year that the FDA lacks scientists with experience in biologics and cell-based
therapies.
Among possible candidates to lead the FDA is Steven Nissen of the Cleveland Clinic, whose medical articles on,
and criticism of, several popular drugs and the FDA have angered drug makers.
—Alicia Mundy
online.wsj.com