In a move that leaves you wondering about health policy in this country, the Food and Drug Administration is considering loosening regulations on "off-label" promotion of drugs. The Wall Street Journal reports:
The FDA's move already is raising objections from industry critics. Democratic Rep. Henry Waxman of California wrote to the agency urging it to hold off on issuing the guidelines, which he argued would create a "large loophole" in the laws against off-label promotion. "It's a conflict of interest for the company to be promoting sales when they haven't been able to establish that a drug is safe and effective through the rigorous FDA process," Mr. Waxman said.
On his blog, Merrill Goozner writes:
As the nation grapples with how to pay for skyrocketing health care costs and policy wonks grapple with how to get more physicians to follow evidence-based medical practices, the Bush administration's FDA... has proposed opening the floodgates to wider promotion and use of unproven drugs.There's a name for that kind of policy: Lack-of-Evidence-Based Medicine.
This is a head-scratcher. It raises anew the old questions about whom the FDA is protecting: citizens or industry.
Posted by schwitz at February 16, 2008 08:17 AM | TrackBack