Callous Misjudgments By Drug Regulators

Thanks to Henry Miller for forwarding his piece that ran in the Wall Street Journal today:

The crisis in vaccine research, development and production is even worse than described in your illuminating May 22 editorial "A Needless Vaccine Shortage," and myopic public policy is largely to blame. A prime example is your description of the CDC's use of its "buying clout and power," to compel steep discounts for purchases. If any interference with market forces were warranted, arguably government should be offering a subsidy rather than imposing what amounts to a punitive tax on vaccine makers.

Wrong-headed, excessive regulation, you observe accurately, is another significant obstacle to pharmaceutical development. Consider, for example, the FDA's position on a vaccine to prevent meningitis C, a bacterial illness that infects thousands of persons and kills hundreds in this country annually. At present no conjugated (comprised of connected components) vaccine against this infectious disease is approved for use in the U.S., although three excellent products are available in Canada and Europe. The safety and efficacy of these vaccines have been demonstrated in pre-licensing testing and in large-scale immunization programs, with more than 20 million doses administered. But jealous of its prerogatives, the FDA refuses to recognize the foreign approvals, although such "reciprocity" is supposed to be a goal of discussions among international regulators. When asked about the FDA's cooperation on this issue, a European regulator responded, "It's like discussing the Thanksgiving dinner menu with the turkeys."