Regulatory Shockwaves

The shockwaves of Dr. Scott Gottlieb’s announcement this week that he is leaving his post as FDA Commissioner are still rippling through the life science industry. One of my colleagues at Halloran Consulting forwarded me an announcement from STAT News about Dr. Gottlieb with an ominous intro “Oh no…”

FDA has made very public and very consistent efforts during Dr. Gottlieb’s tenure to address the most pressing public health issues of our generation. The Agency has engaged with both industry and the public on nutrition, food safety, and drug pricing but the two most visible efforts have been in addressing the opioid epidemic and the scourge of vaping/e-cigarettes. FDA has brought a public and consistent voice by applying regulatory pressure that is truly in line with FDA’s mission of protecting the public health. Dr. Gottlieb’s twitter feed has been reflective of the focus that FDA has placed in seeking to address the clear and present danger that opioids and vaping/e-cigarettes present to human health.

Drug and device development is by nature high risk/high reward. Each promising product concept faces a gauntlet of scientific, clinical, and financial challenges that in most industries would force executives to shut down a program and move on to something less risky. The purpose of industry obviates that – the risks while real, do not stop us from investing our intellect, our time, and investors’ money to seek treatments for disease and to bring hope to patients. That purpose is a thread that links research labs, biopharma startups, and commercial pharma and medtech companies.

We are generally wary of regulators and often assume that part of their job is to slow down innovation, ask more questions, or demand more data in the name of protecting the public health. A great pitch to investors or a thorough board presentation will invariably include discussion of the regulatory path, alongside the finances, IP, and market potential. The clearer that regulatory path, the less risky the investment becomes. As an industry, we value consistency, predictability and clarity from FDA. Dr. Gottlieb joined FDA in May 2017 and seemed to immediately set out to invigorate the Agency. The Agency seemed overnight to become more welcoming and inviting for discussion of innovation. For example, the Pilot Program on Software as a medical device, where FDA encouraged product developers to bring concepts in early so the appropriate, least burdensome regulatory path could be defined. Our clients experienced steady improvements in responsiveness from FDA and a willingness to engage in early discussions through the Fast Track or Breakthrough pathways. All in all, Dr. Gottlieb’s FDA was more predictable than FDA of the recent past and that regulatory clarity matters to each and every development program.

It will be very interesting to see how the Agency moves forward with the initiatives and efforts that Dr. Gottlieb championed. As an industry, we were just beginning to realize some of the benefits of a more open, more communicative and much more collaborative FDA, and therefore we are eager to hear who might be next in line to lead the Agency. We are keeping a very close eye on what happens in the next few weeks with FDA and more importantly, how the department of Health and Human Services moves to find the next FDA Commissioner. Halloran will continue to comment in this space as we know more information.