Regulatory Shockwaves

Originally published on LinkedIn.

Written by Kimberlee Raymer, Joanne LaValle, and Claudia Fehling.

The shockwaves of Dr. Scott Gottlieb’s announcement on March 5 that he is leaving his post as FDA Commissioner are still rippling through the life science industry. One of my colleagues here at Halloran Consulting Group forwarded me an announcementabout Dr. Gottlieb with an ominous intro “Oh no…” 

FDA has made very public and 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 was 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, 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 began his FDA tenure in May 2017 and seemed to immediately set out to invigorate the Agency. Seemingly overnight, FDA became more welcoming and inviting for discussion of innovation.

For example, the Agency initiated a Software Pre-Certification Pilot Program to develop a more efficient regulatory path for software-based medical devices that focuses on the manufacturer and its processes. Pharma and Medtech companies also 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. 

FDA’s Center for Devices and Radiological Health (CDRH) has made huge progress in the past year with many new initiatives planned for the upcoming year. In 2018, FDA announced a record breaking 106 novel device approvals, which surpassed the 2017 record of 99 approvals. CDRH also approved or cleared 9 breakthough devices in 2018. CDRH has a number of initiatives set for 2019, including an entire reorganization of the Center to create a more efficient infrastructure. The CDRH reorganization will begin on March 18 and is set to be completed in September 2019.

Fortunately, the life sciences industry did not need to wait long for Dr. Gottlieb’s successor to be announced. On March 12, it was announced that Dr. Ned Sharpless, Director of the National Cancer Institute, had been appointed Acting FDA Commissioner.

Regarding Dr. Sharpless’s appointment, Health and Human Services Secretary Alex Azar stated “There will be no let-up in the Agency’s focus, from ongoing efforts on drug approvals and combating the opioid crisis to modernizing food safety and addressing the rapid rise in youth use of e-cigarettes.”

Based on his background in oncology (UNC Medical School and Mass General Hospital) and experience at NCI, his appointment seems promising for ongoing FDA efforts to bring new and effective therapies to cancer patients. We will be keen to learn how Dr. Sharpless will take over the reins at FDA and how smooth the transition goes from Dr. Gottlieb.

Dr. Sharpless is experienced in drug development, having co-founded two biotech companies in the past, and has worked closely with FDA. In a statement from Dr. Gottlieb he welcomed the addition of Dr. Sharpless, “Dr. Sharpless is a valued colleague to the FDA and is deeply committed to public health. Over my time at the FDA, I got to know him very well. Dr. Sharpless shares our mission and I know he will be embraced warmly by the Agency’s professional staff.” In addition, Dr. Gottlieb stated, “Under his skilled leadership, I’m confident the transition will be seamless and the FDA will continue to secure its consumer protection role and advance policies to promote innovation and safety for families”.

It will be very interested to see how Dr. Sharpless moves forward with the initiatives and efforts that Dr. Gottlieb championed. This could be a particularly busy few weeks for FDA, and the Medtech industry, waiting to see where Dr. Sharpless priorities lie. He will be inheriting an Agency with substantial new initiatives under way (Dr. Gottlieb provided public statements recently on oversight of cosmetic evaluation and additional user fees from the tobacco industry), facing a favorable change in their budget (the White House has proposed an increase in funding for FDA amid an overall decrease in the Health and Human Services Budget for fiscal year 2020), and under intense pressure from patients for access to new therapies. 

The first few public statements from Dr. Sharpless will hopefully provide some indication of his priorities and the direction FDA might take under his leadership.