Holes in U.S. Drug Safety Net
Consumer Reports: Drug Approval, Follow-Up 'Flawed'
After Drug Approval: Patient Beware continued...
three to six months to catch up with the ad. By that time, the damage is
done. You need an approval system before, not after the ads hit the media. They
should submit copy for vetting by the FDA, and the FDA needs resources for
this. They don't have the personnel or the money."
The Consumer Reports article notes that PhRMA in August 2005
announced guiding principles for direct-to-consumer ads, including a wait
before advertising new drugs. As of November, the article reports, most of
PhRMA's 33 members had signed on.
Independent Drug Safety Board Needed?
Currently, the FDA's drug-safety office is one of 12 subgroups reporting to
the director of the FDA's Center for Drug Evaluation. It's been lacking a
permanent chief for some time.
Lipman says there should be a drug safety office -- with regulatory teeth --
outside the FDA.
"What is really needed, in our opinion, is an independent office of drug
safety: nonbiased safety experts not part of either the pharmaceutical industry
or the FDA," he says. "The same people can't be responsible for drug
approval and drug safety. It just makes it that much harder for a drug to be
withdrawn by the people who approved it."
Gardner isn't so sure. He thinks that a drug safety office would be no
better than the expert advisory panels that currently advise the FDA. Instead
of a new layer of bureaucracy, he would like to see more power given to these
panels of experts.
PhRMA's Trewhitt doesn't see the need for any of this. "Simply put, the
FDA still has the world's best drug safety record," he says.
Institute of Medicine to the Rescue
Lipman, Gardner, and Trewhitt all praise one thing about the FDA. The agency
already has asked for help. Last year, it turned to the independent Institute
of Medicine (IOM) for advice. An IOM committee has since been holding hearings.
Its recommendations are expected in July 2006.
"The FDA has asked the IOM to thoroughly investigate the drug safety
system," Trewhitt says. "It would behoove us to wait to see the