WHAT'S BEHIND THE FLU VACCINE SHORTAGE

"The start of another flu season has found Americans facing a shortage of
influenza vaccine. How did this shortage come about? How can we prevent
recurrences in the future?

According to Devon Herrick, a senior fellow with the National Center for Policy
Analysis, there are several reasons why firms avoid the U.S. market, but they
can be summed up with one word "profit."

Estimates vary, but product liability lawsuits by people who have adverse
reactions may account for much more than half of the cost of most vaccines.

Another cause of shortages is overregulation. This could be overcome by
reciprocal regulatory agency approvals, which would allow vaccines approved and
used successfully in other developed countries to be sold in the United States,
says Herrick.

Currently, the Food and Drug Administration (FDA) is responsible for inspecting
and certifying plants and processes used to produce vaccines just as it is for
drugs.

Vaccines manufactured abroad that have not been produced under conditions
approved by the FDA may not be sold in
this country. While this is meant to protect the public, it also raises the
cost and delays the introduction of potentially lifesaving vaccines.

The adoption of common standards and a reciprocal regulatory approval process
would benefit all of the countries involved by creating a wider market for their
vaccine products, and benefit their citizens by giving them access to more
sources of supply, says Herrick.

Source: Devon Herrick, "What's Behind the Flu Vaccine Shortage," Brief Analysis
No. 493, National Center for Policy Analysis, October 28, 2004.

For text http://www.ncpa.org/pub/ba/ba493/

For more on Drug Research and Development http://www.ncpa.org/iss/hea/