Curbing Industry Sponsors’ Incentive to Design

Many studies have shown that commercially-sponsored clinical trials are more likely than publicly-financed trials to produce results that are favorable to the sponsoring firm. There is no research, however, to support the allegation that industry sponsors intentionally design methodologically inferior studies. Rather than empirically determining whether commercially financed research is less sound than its publicly supported counterpart, this Article focuses on the financial incentives created by the current regulatory climate. This Article demonstrates that pharmaceutical companies are being put to a cruel choice between optimally advancing the medical literature and honoring their fiduciary duties to shareholders by designing suboptimal phase IV protocols. As pharmaceutical companies have little incentive to design suboptimal protocols for other types of trials, this Article focuses exclusively on non-required post-marketing studies not intended to support supplemental NDA labeling changes. After arguing that the present regime is incapable of reining in conflicted sponsors, this Article offers a solution that has the potential to align industry interests with the public health. ∗ M.D. Candidate, Yale University School of Medicine. J.D., magna cum laude, Harvard Law School, 2006; B.A., magna cum laude, Brandeis University, 2003. I owe a large debt to Peter Hutt, who tirelessly reviewed multiple drafts of this paper. I would also like to thank the following people for their helpful comments: Ronald Falit, Larry Thoms, Nancy Myers, Robert Temple, Bernard Schachtel, Troyen Brennan, Regina Herzlinger, David Rosenberg, John Golden, Bert Spilker, Arthur Caplan, Frank Rockhold, Alan Goldhammer, and Laurence Tribe. For help tracking down research material, I would like to thank Peg Hewitt. Finally, I would like to give a very special thanks to my wife, Laurel Falit. FALIT_FINAL 10/18/2007 8:47:37 AM 970 SETON HALL LAW REVIEW [Vol. 37:969