FDA's Use of Negative Publicity as an Enforcement Mechanism

Abstract

This paper analyzes FDA’s use of negative publicity as an enforcement mechanism, both generally and in the specific instance of the agency’s regulation of phenylpropanolamine (“PPAâ€). While FDA does have explicit statutory authority to issue negative publicity in limited situations, both the agency and the courts have broadly interpreted FDA’s power to extend beyond these statutory limits. In practice, while FDA has sometimes used negative publicity consistently with its statutory authority, it frequently abuses its powers, by issuing public warnings that are overbroad and that are not based on any scientific evidence, and by using very negative publicity to coerce companies to comply with the agency’s requests for voluntary recalls. When compared to the agency’s other statutory enforcement powers, negative publicity has both advantages and disadvantages: it is a cheap and fast way to protect the public from serious dangers, but it has the potential to cause undue public alarm and confusion, and it provides regulated companies with very little procedural protection. FDA’s issuance of a public advisory about the stroke risk of PPA in November 2000 highlights many of the problems of FDA’s use of negative publicity as an enforcement mechanism. The advisory caused significant financial losses to the regulated companies and consumer confusion. Instituting a rule-making proceeding to formally ban PPA would have avoided these problems and allowed PPA manufacturers to effectively challenge FDA’s actions.