Vioxx's History and the Need for Better Procedures and Better Testing

Abstract:     
When Vioxx was removed from the market because of risks found after approval, issues arose about the adequacy of FDA's authority and procedures to require warnings and testing for approved drugs. This paper examinies the regulatory and legislative history about the debate and the changes adopted by Congress in 2007 to strenthen FDA's authority. The agency has now been given authority to impose civil money penalties when needed changes are not made, but before this authority can be used the agency has to establish dispute resolution procedures about the changes needed. The article, published in 37 Seton Hall L. Rev. 941 (2007) considers the factors that bear on the type of dispute procedures that should be considered. The article also examines the value of encouraging better initial testing and comparative efficacy testing for drugs and the means to encourage that testing.

Number of Pages in PDF File: 28

Keywords: drug legislaton, drug safety, Vioxx, FDA, Food and Drug Administration, drug testing

Accepted Paper Series