Consider the FDA's precipitate and inappropriate response to the 1999 death of a patient in a University of Pennsylvania gene-therapy trial for a genetic disease. Although they can dramatically compromise public health, type 2 errors caused by regulators' poor judgment, timidity, or anxiety seldom gain public attention. Usually, only the company that makes the product is likely to be aware. Likewise, if the regulators' mistake precipitates a corporate decision to abandon the product, cause and effect are seldom connected in the public mind. There may be no direct evidence of the lost societal benefits or of the culpability of regulatory officials.
Exceptions exist, of course.
A few activists, such as the AIDS advocacy groups that closely monitor the FDA, scrutinize agency review of certain products and aggressively publicize type 2 errors. Even when such mistakes are exposed, regulators frequently defend type 2 errors as erring on the side of caution, as they did in the Pennsylvania gene-therapy case. Too often this euphemism is accepted uncritically by legislators, the media, and the public, and our system of pharmaceutical oversight becomes progressively less relevant to the public interest. The self-interest of individual officials and the FDA as a whole profoundly affects the agency's receptivity to and the fate of regulatory reform. During the past 30 years, agency officials have received no bouquets from Congress or the public for attempts to decrease regulatory responsibilities, improve efficiency, and reduce requirements.