By Sy Mukherjee
March 15, 2019

Happy Friday, readers (and beware the Ides of March).

It’s a relatively slow news day in the health world – but Food and Drug Administration (FDA) commissioner Scott Gottlieb is still making waves on his way out the door.

Gottlieb unexpectedly announced he’ll be stepping down next month following a short-but-spirited tenure leading the agency. He waged tough battles against tobacco and vaping companies, emphasized food safety, spurred new regulations to expedite a record number of drug approvals, and attempted to haul the FDA’s approach on digital health into a 21st century world.

On Thursday, he issued what, depending on your perspective, is a roasting of or challenge to the drug industry: Modernize yourselves, too.

Gottlieb listed various changes the FDA has made in the past two years to modernize how clinical trials are conducted, including new protocols to incorporate various trial designs that are more streamlined and can incorporate new incoming data (such as the use of novel biomarkers to assess a drug). Such protocols could theoretically cut administrative costs and expedite the entire clinical process. But the industry, in his view, has been slow to get with the program.

“Unfortunately, we’ve seen a continued reluctance to adopt innovative approaches among sponsors and clinical research organizations. In some cases, the business model adopted by the clinical trial establishment just isn’t compatible with the kind of positive but disruptive changes that certain innovations can enable,”Gottlieb wrote in a statement. “We appreciate that scientific and technical complexity is a real and ongoing challenge, but industry and academia also need to invest in and leverage these approaches and develop new incentives that reward collaboration and data sharing across the clinical research enterprise.”

This ostensible reluctance by drug makers is a bit of a surprise considering the plummeting return on investment in many pharma companies’ R&D programs – or, perhaps, just a case of inertia.

Read on for the day’s news, and have a wonderful weekend.

Sy Mukherjee


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