Several clients have asked what Commissioner Gottlieb’s departure will mean – to their own industries and other FDA constituencies. To ponder the question, I replaced my private consultant hat with my old “bureaucrat’s hat” from my days with CMS and FDA.
As I considered the question, and digested the trade press, I realized the question doesn’t quite sit right in my gut. I struggled to find the cause of the heartburn. Here’s my diagnosis.
Rarely are FDA Commissioners able to tackle a personal agenda. At best, the Executive Branch (and Congress) might support one “sweetheart” project. First Ladies typically get the same, whether small (school lunch reform, Obama) or gargantuan (health reform, Clinton). At FDA, a broader public health crisis usually overtakes the sweetheart project (think, Opioid Crisis), and even a well-earned attempt for a second round typically meets a thousand stabs from the White House, Congress and lobbyists.
As with any new Commissioner, Dr. Gottlieb’s incoming agenda sounded promising and ambitious. Its focus was public health threats: drug shortages, tainted imports, faster reviews for key therapies. He found a job far different than the one he planned. Opioids, drug pricing, teenage vaping. His job became tackling the crisis de jour and addressing statutory mandates.
Somehow, despite these battles not falling in his inaugural agenda, Commissioner Gottlieb addressed each crisis and still made moves to speed review of therapeutics. Biotech investors cheered. Conversely, with his departure, biotech stocks have dropped in fear a new Commissioner will fail to put faster reviews onto his (her) agenda.
I don’t quite understand the concern.
Speedier drug reviews weren’t a whim of one Commissioner to be undone by the next. They come from Congressional mandates that obligate FDA to act. So, quick review for gene-based therapies – it’s in the law. Approval delays might not be in FDA’s hands, but a function of factors from far afield – European trade harmonization, technical barriers like package size and NDC coding, coordination with Medicare. Even $500K maintenance drugs don’t seem to trigger a National Conversation about cost. (Nor does a voucher worth $120M to the sponsor of the first cannabis-based drug, by the way.)
So, did speedier biotech approvals arrive on Dr. Gottlieb’s watch — YES. Through his personal leadership – not really. Ditto the biosimilars, in my view. Yet the question still arises, from many quarters – what will come of Commissioner Gottlieb’s legacy and will the initiatives continue. To which my answer is, I fail to see the question.
FDA’s approach on a couple of Gottlieb projects might see some slowdowns, especially those requiring personal leadership to buck the winds of Congress, the White House and the lobbyists. However, overall the projects will continue because the law says so. There’s no prosecutorial discretion when it comes to teenage vaping addiction, or opioid deaths… or marketing reviews for the biotech pipeline. FDA is a public health agency, and just as Dr. Gottlieb needed to set aside his own inaugural wish list to manage the work demanded, so will his successor.
That’s my memory of years in government policy. Whatever my project – cancer drug access, dialysis payment reforms, opioid abuse, the assignment was not to implement the Commissioner’s pet project but rather the mandates of our legislation and the demands of public health.
So is the recent drop in big biotech stocks due to uncertainty over a new Commissioner? I hope not, because I just don’t see it there. Value investors, take note.