The Right Coast

October 19, 2004
The Flu Vaccine Shortage: Another Example of Regulatory Failure
By Mike Rappaport

Kevin Drum has a good post on this. (Hat tip: Instapundit) After reviewing several possible explanations for the shortage, he concludes:

That leaves explanation #5 (the FDA regulations have gotten tighter over the years, and vaccine makers have had an increasingly hard time meeting them because it requires expensive plant upgrades). And at first glance it seems the most likely to be the real deal. The FDA has a famously tight regulatory regime, made even tighter in the late 90s, and as a result the United States has only two approved manufacturers of flu vaccine while Britain has half a dozen. The bottom line is that there are other flu vaccine manufacturers besides Chiron and Aventis, but they don't sell into the U.S. market because the cost of complying with FDA regulations is higher than the narrow profits they could expect to make from selling flu vaccine.