The
House passed legislation that is expected to give federal drug regulators
significantly more money and power to ensure the safety of the nation’s drug
supply.
Senate passage is expected,
and President Bush will probably sign the measure quickly—all part of a race to
forestall dismissal notices Friday for some 2,000 employees of the Food and Drug Administration.
The legislation was welcomed
by both industry and consumer groups, who all found something to trumpet in the
mammoth bill.
The bill combined several
pieces of legislation governing drug industry user fees, new rules involving
the disclosure of clinical trial results, money for studies of older medicines,
incentives for tests in children, and even the conflicts of interest of drug
agency advisers.
“It is the mother of all
F.D.A. reauthorization bills,” said Dan Troy, a former general counsel for the
drug agency who represents drug makers.
Even with all of these
provisions, however, the bill does not address every controversial issue
involving the agency. Cancer patients marched outside F.D.A. offices to protest
the agency’s decision not to approve Provenge, a drug for prostate cancer. The legislation passed does nothing to address
calls by some patient advocacy groups for the agency to allow the sale of some
drugs while they are still being researched. Nor does the bill do much about
concern over the safety of imported foods beyond creating a registry of
adulterated foods and a statement that Congress “should work to develop a
comprehensive response to the issue of food safety.”