FDA can't guarantee drug safety

The government's own auditor says FDA is failing. Testifying before a Congressional subcommittee yesterday, the director of healthcare for the Government Accountability Office said the agency can't guarantee the safety of the U.S. drug supply because its oversight of foreign drug manufacturers is horribly lax [1]. The agency's record-keeping is so poor, it doesn't even know which facilities haven't been inspected, the GAO rep said.

And at the current rate of inspection, it would take the agency 13 years to examine each facility once--and those are just the factories it knows about. Volunteers often conduct inspections. And the facilities are given advance warning that inspectors are coming. Luckily, U.S. drug makers don't rely on the FDA to ensure its foreign suppliers are delivering quality goods. The companies conduct their own inspections, and they test some shipments to make sure they're OK.

- read the report [2] from the New York Times

Related Articles:
Overseas drugmaking goes unsupervised. Report [1]
Poll finds problems at the FDA. Report [3]
FDA offers safety reforms to skeptical lawmakers. Report [4]
IOM slams FDA, calls for major reforms. Report [5]