More flu SNAFU: The FDA’s June 2003 inspection

Forbes, USA Today, and the Wall Street Journal report that the Food and Drug Administration found contamination problems at the Chiron plant in Liverpool in June of 2003. Yet even after Chiron announded six weeks ago that quality-control problems required delaying shipments of vaccine from August until October, apparently no one at the FDA, the CDC, or the office of the Assistant Secretary for Health got on the horn to UK authorities. Instead, FDA kept listening to happy h.s. from Chiron itself, and was caught by surprise when the Brits pulled the plug.

Apparently the FDA is now convinced that none of this year’s Chiron product is salvageable, so this wasn’t just the UK regulators giving Chiron a hard time about its recordkeeping.

The acting director of FDA, Lester Crawford — a Bush nominee, of course — has obviously learned that not admitting mistakes is the fundamental principle of the Bush Administration:

Crawford said the FDA followed standard procedures, and he would not change anything the FDA has done. “This is the way we’ve always done it, and it’s worked very well in the past. So, no, we would not have altered the procedures.”

On the other hand, in saying that U.S. officials knew that there was going to be a shortage — as opposed to having reasons to think there might be shortage and that something needed to be done — Senator Kerry was almost certainly wrong. What would have been the point? This looks like a mistake, and a big one. No need to make it into a conspiracy.

Author: Mark Kleiman

Professor of Public Policy at the NYU Marron Institute for Urban Management and editor of the Journal of Drug Policy Analysis. Teaches about the methods of policy analysis about drug abuse control and crime control policy, working out the implications of two principles: that swift and certain sanctions don't have to be severe to be effective, and that well-designed threats usually don't have to be carried out. Books: Drugs and Drug Policy: What Everyone Needs to Know (with Jonathan Caulkins and Angela Hawken) When Brute Force Fails: How to Have Less Crime and Less Punishment (Princeton, 2009; named one of the "books of the year" by The Economist Against Excess: Drug Policy for Results (Basic, 1993) Marijuana: Costs of Abuse, Costs of Control (Greenwood, 1989) UCLA Homepage Curriculum Vitae Contact: Markarkleiman-at-gmail.com