Independent Drug Testing to Ensure Drug Safety and Efficacy
Marc A. Rodwin
Suffolk University Law School; Harvard University - Edmond J. Safra Center for Ethics
September 19, 2013
Edmond J. Safra Working Papers, No. 23
This article analyzes a reform proposal that would preclude bias in clinical trials used to test drugs that is inherent in the current system where the pharmaceutical firms sponsoring the drug designs the clinical trial and selects the researchers who will conduct the research. Under the current approach manufacturers can frame the research in a way that biases the result. Moreover, organizations that perform the research depend on the pharmaceutical firm sponsor for their income, an arrangement that fosters dependency corruption. The reform proposal would remove all drug firm influence on the design and conduct of clinical trials used to decide whether to allow marketing of a drug. A federal agency would select the researchers to design and conduct the phase II and III clinical trial, or the clinical trial would be conducted by an independent government agency. The pharmaceutical firm that wished to market the drug would be required to finance the clinical trial. Between the late 1950s and 1980s, reformers and congressional leaders championed variations of this proposal, but pharmaceutical industry opposition blocked its enactment and so the federal government pursued alternative strategies, which have proved ineffective. By the mid-1990s, scandals prompted several leaders in drug policy and research to again advocate legislation to require independent drug testing. The paper concludes by the discussing difficulties that will arise in implementing this proposal and how these can be overcome.
Number of Pages in PDF File: 38
Keywords: Institutional Corruption, clinical trial, bias, drug, financing, pharmaceutical, dependency corruption, independent drug testing, drug marketing, FDAworking papers series
Date posted: September 19, 2013
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