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83 Mo. L. Rev. 39 (2018)
The Drug Innovation Paradox

handle is hein.journals/molr83 and id is 45 raw text is: The Drug Innovation Paradox Erika Lietzan* - ABSTRACT In medicine today, we face an innovation paradox. The companies that develop new medicines are highly dependent on a period of exclusive market- ing after approval, to fund their research and development programs. But longer research and development programs are not associated with longer pe- riods of exclusive marketing. Instead, the period of exclusive marketing may be shorter. Exclusivity that dwindles with each additional month ofpre-com- mercialization research would ordinarily lead innovators to be more efficient, but the drug regulatory system leads to a different result. In this system, the length of any particular premarket program turns largely on considerations not within the firm's control. The design and length of the program are afunc- tion of variables that include the molecule and its chemical class, its mecha- nism of action, the disease and disease stage targeted, the outcomes that can be formally tested, the nature of other treatments on the market, and scientific obstacles and opportunities at the time. Certain types ofmedicine -for exam- ple, drugs for long-term use and prevention of disease, drugs to stop progres- sive or degenerative diseases, and drugs for early stage cancer - are more likely to require longer research and development programs. Thesefindings have significant implications for innovation policy. There is a paradox in drug innovation: we have chosen to incentivize research and development with a post-market reward, but as the research and development timeline increases, the post-market reward for that innovation remains the same or decreases. If the length of the premarket process correlates with particular drug types, dis- ease targets, or studied outcomes, we may be offering an inadequate incentive in entire areas of medicine where we desperately need new treatments. *Associate Professor, University of Missouri School of Law. This article would not have been possible without the support of a Thomas Edison Innovation Fellowship from the Center for the Protection of Intellectual Property (CPIP) at George Mason University's Antonin Scalia Law School. It benefitted also from discussion at a faculty workshop hosted by the Saint Louis University School of Law. I am grateful to many for comments, advice, and input, including Bill Chin, Eric Claeys, Richard Epstein, Chad Flanders, Joseph Gabriel, Rob Gatter, Jesse Goldner, Tim Greaney, John Griesbach, Sam Halabi, Peter Hutt, Jay Kesan, Zorina Khan, Yvette Liebesman, Kris- tina Lybecker, Carol Needham, Michael Risch, Ted Sichelman, Paul Tatum, Jane Was- man, Sidney Watson, and Patricia Zettler. I am especially grateful to Dr. Temple at FDA for a close read and challenging comments. Mistakes of course are my own. Finally, I am grateful for the research support of Cynthia Shearrer, Associate Law Li- brarian at the University of Missouri School of Law, and for the research assistance of Matthew Davis ('17), Erika Dopuch ('17), Jason Home ('17), Max Mauldin ('18), and Emily Titus ('19) at the University of Missouri School of Law.