FDA Under Fire

DRUGS

The Food and Drug Administration (FDA) was established in 1906 to
ensure the safety, efficacy and labeling of pharmaceutical products.
Today, the integrity of the FDA's approval process is in question.

A recent USA Today study reveals that there may be conflicts of
interest among advisory committee members recommending FDA drug
approvals. Some members are financially linked to the pharmaceutical
corporations that have products under FDA review. While federal law
prohibits such participation without FDA-approved waivers, they're
apparently granted with alarming frequency.

The study found that in 159 advisory committee meetings between
January 1998 and June 2000, 40 requests for conflict-of-interest waivers
were refused, while 803 of the 1,620 attending members had been granted
waivers. For instance, in the two meetings discussing Prozac and Zoloft,
four of the 14 members had been issued waivers.

"We go through a waiver process for all advisory committee members
and look at them in terms Of their conflicts for each and every meeting,"
says FDA spokesperson Susan Cruzan. "If they've worked on a specific
product, they are automatically refused from the meeting. The FDA looks
to balance the need for an expert versus the conflicts."

According to Dennis Cauchon, the reporter who conducted the
research, the FDA is required to document conflicts and why the person's
service is more important. Copies of the waiver statements are available,
he says, "but if you go to the Freedom of Information Act (FOIA) office
to get one, [parts of the statement] are blacked out."

USA Today is currently pushing to make these statements publicly
available through the FOIA office.

ILLUSTRATION (COLOR)