FEDERAL VACCINE POLICY NEEDS A BOOSTER
October 22, 2004
Flu vaccine should be an attractive product for manufacturers -- it's used every year, recommended for virtually everyone and is generally safe -- but as with most other vaccines, it isn't profitable. That has discouraged vaccine development to the point that supplies of many lifesaving vaccines are dangerously low, says Henry I. Miller, a physician and fellow at the Hoover Institution.
According to Miller, these are the remedies that must be undertaken immediately:
- The U.S. Centers for Disease Control and Prevention and the Food and Drug Administration should perform clinical tests to see whether the injectable flu vaccine is effective when diluted (in order to stretch the supply).
- Government health officials should make it clear that even if there are shortages of vaccines, there are orally administered drugs (such as Tamiflu) that can prevent -- and treat -- flu.
- The Centers for Disease Control (CDC), the largest domestic purchaser of vaccines, should not use its buying clout to compel deep discounts for purchases.
We need a fundamental change in mind-set: The rewards for creating, testing and producing vaccines must become commensurate with their benefits to society, as is the case for therapeutic pharmaceuticals, says Miller.
- Our government should accept reciprocity of vaccine regulatory approvals between the United States and the European Union.
- Companies should also be given tax credits to defray research and development costs, and vaccine developers should be guaranteed exclusive market rights for a fixed period.
- Finally, a regulatory-compliance defense should be allowed so that after a manufacturer meets the rigorous regulatory requirements for vaccine approval, it would not be culpable for any mishap from use of the product, and damages would be compensated by the government.
Source: Henry I. Miller, "Federal Vaccine Policy Needs A Booster," San Francisco Chronicle, October 8, 2004.
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