As this issue went to press, President Trump named his pick to lead the FDA, nominating Dr. Scott Gottlieb to be commissioner of the agency. If confirmed by the Senate, Gottlieb will succeed Robert Califf, the former FDA commissioner who formally stepped down before the Trump administration took office, to become the nation’s top drug regulator. Stephen Ostroff is currently serving as acting commissioner on an interim basis until Senate confirmation hearings.

Gottlieb, a physician, resident fellow at the American Enterprise Institute and a venture partner at New Enterprise Associates, was the keynote speaker at Contract Pharma’s, Contracting & Outsourcing Conference and Tabletop Exhibition in 2015. He addressed forces driving the transformation of healthcare in a dynamic presentation, entitled, “Beyond Cures: The 2016 Agenda for FDA Reform.” You can view slides from the talk here if you’re interested: www.contractpharma.com/contents/view_conference-sessions/2017-03-21/beyond-cures/.

He spoke about some of the secular issues affecting FDA and secular policy issues as well as some of the legislative challenges the agency is facing and what we’ll likely see over the coming years with respect to FDA reform and new legislation that would affect the FDA approval process.

Gottleib served a stint as the deputy FDA commissioner under President George W. Bush and one of the main problems he will face if confirmed is the state of high drug prices.
President Trump in his first address to Congress called for the price of prescription drugs to come down. He said his administration and Congress should “work to bring down the artificially high price of drugs and bring them down immediately.”

Combatting high drug prices was one of the cornerstones of his campaign. The ongoing pricing debate reached a pinnacle when then-CEO of Turing Pharmaceuticals, Martin Shkreli, hiked the price of an old med, Daraprim, by more than 5,000% in 2015.

Perhaps President Trump has turned to Gottlieb for help in this regard. Gottlieb has said in the past that the main problem behind high drug prices isn’t the cost of new, specialty drugs but instead old drugs whose sellers can indiscriminately raise prices because there isn’t enough competition from generics, like in the case of Daraprim.

Referencing an op-ed Gottlieb wrote for the Wall Street Journal,  a piece in the Washington Examiner said “generic drug applications used to cost about $1 million but can now cost as much as $20 million, making it too expensive for companies to bring their competing products to market.”

The Examiner story goes on to say that Gottlieb at the time criticized the call among Democrats, led by Hillary Clintaon, to more heavily regulate drugmakers. Gottlieb said instead of throwing new regulations on new drugs, the FDA should focus on opening the door to generic versions of old drugs to help bring costs down. I guess we’ll see how it plays out in the months ahead.

Tim Wright, Editor
twright@rodmanmedia.com