The Daily Sandwich

"We have to learn the lesson that intellectual honesty is fundamental for everything we cherish." -Sir Karl Popper

Location: Boston, Massachusetts, United States


Tuesday, June 27, 2006

FDA safety enforcement down 54%

The FDA has been one of the many agencies facing accusations of cronyism, incompetence, and an anti-science agenda under the Bush administration. The White House has become well-known for a fox-in-the-henhouse approach to filling cabinet positions, as David Sirota pointed out yesterday in citing the EPA's attempt to cover up the potential health problems created by the 9/11 building collapses-- under the gaze of an appointee who represented asbestos manufacturers.

Now the pretty awesome Henry Waxman has produced evidence that Bush's FDA has been somewhat lax in enforcing safety standards over the last five years-- even when people are dying.

Food and Drug Administration enforcement actions targeting safety problems, quality lapses and misleading claims have fallen sharply even though violations have not, according to statistics released Monday by Rep. Henry A. Waxman (D-Los Angeles).

In 2005, FDA headquarters issued 535 warning letters to companies, a 54% decline from 1,154 such notices issued in 2000, according to a report by the House Government Reform Committee's Democratic staff.

But over the same period, the number of violations reported by FDA inspectors in the field barely budged, dipping just 1% — from 6,334 to 6,268. (. . .)

The report identified 138 cases in which headquarters did not take enforcement actions recommended by inspectors. Many involved medium-sized or small companies selling over-the-counter remedies, not pharmaceutical giants. "I can't explain why the FDA is taking a position where they are being passive," Wilkes said.

One of the cases Wilkes reviewed involved an over-the-counter asthma medication containing an ingredient that could prompt dangerous side effects, particularly in children. Another involved a hangover remedy that contained toxic levels of caffeine and had sent three people to the emergency room. In both cases, FDA headquarters did not send warning letters within specified timeframes.

In another case, the agency ultimately did not take enforcement action against an Ohio medical gas supplier after a nitrogen tank mislabeled as oxygen was connected to a nursing home's oxygen-delivery system. Four patients died as a result.