Should the federal government become more involved in vaccine manufacture and distribution? (Pro & Con).

YES

I do not believe that market forces alone will satisfy this country's need for routine childhood and adult vaccines, or vaccines related to bioterrorism. Government participation is necessary to ensure that public health remains the priority.

Our vaccine supply is in trouble. In the fall of 2001, there were 23 licensed vaccines. Three were withdrawn for safety reasons, supplies of four were delayed, and supplies were insufficient to meet demand for three. Moreover, a single manufacturer produces seven of the currently licensed vaccines. Do we really want a system that is dependent on a single company to make crucial vaccines?

Just four major vaccine manufacturers are in business today, and only two are based in the United States. There were four times as many vaccine manufacturers just 20 years ago. If it's such a great business, why do companies keep leaving?

Companies argue that the Food and Drug Administration's recent regulatory environment has made compliance difficult. It may be true that the FDA has not been as effective as it might have been in informing companies of the rules in a timely and appropriate way. However, if companies are pulling out for regulatory reasons, it's because there is not enough profit to make it worthwhile for them to overcome the regulatory hurdles. The cost of vaccine development is high, and the return on investment limited. We must find other solutions.

Some recent proposals to stimulate the vaccine industry, such as federal tax credits for vaccine development and lengthening of patent protections, are reasonable and worth trying. However, I'm uncertain that these steps alone will solve the problem.

We need a strategic national approach in which the federal government provides active leadership and direction in the manufacture and distribution of vaccines. A National Vaccine Authority (NVA) within the U.S. Department of Health and Human Services is a logical way of accomplishing that.