| Jan Drew 2006-06-28, 9:25 pm |
| http://www.newstarget.com/z019480.html
NewsTarget.com printable article
Originally published June 27 2006
FDA enforcement efforts against drug companies in freefall failure,
concludes inquiry
(NewsTarget) Representative Henry A. Waxman, D-Calif., senior Democrat on
the House Government Reform Committee, recently lead a 15-month inquiry into
the Food and Drug Administration, and found that the agency's enforcement of
food and drug laws has declined sharply since President Bush took over
office.
"Americans have relied on FDA to ensure the safety of their food and drugs
for 100 years," Mr. Waxman said. "But under the Bush administration,
enforcement efforts have plummeted and serious violations are ignored."
According to the inquiry, warning letters issued by the FDA have dropped 54
percent, seizure of mislabled, defective or dangerous products has dropped
44 percent, and its device center has seen a 65 percent drop in enforcement
actions over the five-year period, despite a wave of defibrillator and
pacemaker complaints.
Research conducted at Waxman's request turned up no evidence that the
declining numbers were tied to increased observance of FDA laws and
guidelines. David K. Elder of the agency's Office of Enforcement said the
office had been increasingly focused on more serious violations.
A statement issued by Elder said, "As a result of FDA's focus on those firms
and those violations that present the highest risk to consumers and public
health, the agency has taken prompt, targeted and aggressive action against
firms that are in violation of law."
According to Dr. Sidney M. Wolfe, director of the Health Research Group at
the watchdog organization Public Citizen, the FDA currently receives about
$380 million each year from the same drug makers they are charged with
protecting consumers from.
"The public is getting the kind of FDA that the [drug] industry is paying
for them to get," he said.
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