GAO assails FDA's foreign inspections

Oh, woe is the FDA. The Government Accountability Office is set to release a new report on the agency's terrifically inadequate inspection record overseas [1]. According to the New York Times, which obtained a copy early, the FDA is so understaffed that it would need at least 27 years to inspect every foreign medical device plant and 13 years to check every foreign drug plant. Think that's bad? Catching up on food inspections would take a mind-boggling 1,900 years.

Most disturbing is the fact that the agency is farthest behind in--you guessed it--China, that bastion of impure and unsafe exports. China has more drug and device plants than any other foreign nation, and FDA inspections there are few, the Times notes.

The GAO will present this bad news at a hearing before the House Energy and Commerce Committee, which has been dogging the FDA for months now. One witness set to testify said, "This is a fundamentally broken agency, and it needs to be repaired." We advise the FDA to focus on the "repair" part of that sentence. Today will be painful, sure, but it could lead to a sorely needed increase in funding [2]. If the stars and politicians line up just right, that is.

- read the article [3] from the New York Times
- here's the witness list [4] (.pdf) for today's hearing; find a link [5] to the webcast

Related Articles:
FDA wants satellite offices overseas [6]
FDA badly needs more money, staff [2]
FDA can't guarantee drug safety [7]
Overseas drugmaking goes unsupervised [1]