FDA's Use of Negative Publicity as an Enforcement Mechanism

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FDA's Use of Negative Publicity as an Enforcement Mechanism

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dc.contributor.advisor Hutt, Peter Barton en_US
dc.contributor.author Blevins, Kelly C. en_US
dc.date.accessioned 2012-06-07T04:09:56Z
dc.date.issued 2003 en_US
dc.identifier.citation FDA's Use of Negative Publicity as an Enforcement Mechanism (2003 Third Year Paper) en
dc.identifier.uri http://nrs.harvard.edu/urn-3:HUL.InstRepos:8846784
dc.description.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. en
dc.language.iso en_US en
dash.license LAA en_US
dc.subject Administrative law en
dc.subject publicity, en
dc.subject phenylpropanolamine en
dc.title FDA's Use of Negative Publicity as an Enforcement Mechanism en
dc.type Paper (for course/seminar/workshop) en_US
dc.date.available 2012-06-07T04:09:56Z

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