This week, Congressman Lloyd Doggett released the march-in letter we warned about several weeks ago. Its KEI sponsors then said they were waiting for things to “quiet down” before its release. We assume they tired of waiting. Rep. Doggett’s press release and letter (both linked below) is signed by 51 Democrat House Members and is addressed to President Trump. Misinterpreting Bayh-Dole, the letter demands presidential pressure on NIH to issue guidelines for the B-D price-based march-in order to enable compulsory licensing of prescription drugs. As Francis Collins has explained to Congress, the 1995 CRADA retraction episode conclusively proved that even the possibility of such price controls would deter the private investor research in university life science commercialization NIH needs to implement NIH’s life science mission. To prove his point Collins expressly pointed to the CRADA experience in the “90’s. Speaking at a more recent KEI conference on compulsory licensing, AUTM representative Ashley Stevens echoed Dr. Collins’ comments by emphasizing the Doggett proposal’s inevitable harm to research university education research and public benefit mission.
Times have changed. NIH faces big budget cuts in the Administration’s 2016 and 2017 budgets. Its survival is at stake. The public is even more riled up about drug prices. NIH will be tempted do what it has to do to save itself especially if it has to fight this issue by itself. All price controls harm life science commercialization but not all are not aimed directly at NIH. Doggett’s plan is thus more dangerous this year. Universities should help them. As we warned in our last Report, House Democrats seem to have superseded Rep. Doggett’s demand with their more comprehensive “Improving Access to Affordable Prescription Drug Act”, HR 1776. Whether NIH and research universities are hit by one bullet or ten, life science price controls in any form are lethal to life science commercialization. Any price control scheme will deter private sector investment in commercialization partnerships. Yes, nobody wants to fight drug price controls but silence isn’t playing it safe. You do not have to be high-priced drugs any more than you had to favor trolls to ward off patent reform. Before they act Congress at least should know their harmful implications for university life science research. Please alert them while they’re home on recess during the next two weeks.