FDA panelist rails against lax enforcement

Remember that scathing report from the FDA's own Subcommittee on Science and Technology a couple of weeks ago? One of the Advisory Board members aired his opinion in a written report, and the DrugWonks blog has published it. It's "un-sugar coated," as the blog states. For a very sour taste, scroll down to the conclusion, where Hutt says in no uncertain terms that drug and food safety can't be fixed without doubling the agency's funding, period.

And here's a taste of the report's stats: In 1991, the FDA seized suspect products 168 times and prosecuted 43 criminal cases; in 2007, the agency instituted six seizures, and prosecuted no criminal cases. It hasn't prosecuted a criminal case for at least the last four years. Meanwhile, administrative actions have dwindled, too. The agency issued 1,712 warning letters in 1992. In 2007, it sent out 467. We suppose that might be because the drug industry has suddenly grown incredibly safe. Except for the fact that, according to Hutt, adverse event reports more than doubled from 191,865 in 1996 to 471,679 in 2006. What do you think?

- read the treatise from Peter Barton Hutt
- see the item at Drug Wonks