NCPA - National Center for Policy Analysis


October 29, 2004

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.

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