4 key questions after Gottlieb’s sudden departure

Mar 06, 2019

The announcement this week that FDA Commissioner, Scott Gottlieb, will be leaving his post came as a surprise to many in the industry. 

Although he had his share of detractors, Gottlieb was largely a popular bureaucrat who led a series of impactful policy changes at the FDA. But will Gottlieb’s legacy last once he’s gone? Here are four key questions raised by his departure.  

How will it impact biotech? 

Business industries hate uncertainty, and the sudden questions raised by Gottlieb’s goodbye sent biotech stocks tumbling. The day after the announcement, stocks for Amgen, Biogen and Gilead Sciences were all down by more than 2 percent. 

One biotech analyst told CNBC that because of Gottlieb’s efforts to streamline and speed up the drug approvals process, he was well-liked by the biotech investment community and that it would be hard to find “someone better than him.” Another analyst from Merrill Lynch also said that his departure will likely be a “net negative” for biopharma. 

While the industry waits to find out who will replace Gottlieb, it’s clear that investors are skittish for now. 

How will it impact Trump’s agenda? 

Although Democrats were initially wary of Gottlieb’s ties to the pharma industry, he eventually became one of President Trump’s most respected agency appointees. The day after his announcement, lawmakers from both sides of the aisle said he was better than any other administration official at touting Trump policies, including his efforts to bring down drug prices. 

Gottlieb was also known as being very accessible to lawmakers looking to bend his ear about healthcare reform issues. 

If the next FDA commissioner is a more polarizing figure on Capitol Hill, it could challenge Trump’s ability to push ahead with key regulatory goals in pharma. 

Who will replace him?

So far, no replacement has been announced. One clear front runner could be Amy Abernethy, Gottlieb’s current principal deputy. 

The Wall Street Journal also speculated that other potential nominees include Norman Sharpless, director of the National Cancer Institute and Brett Giroir, the assistant secretary of the Department of Health and Human Services. 

Whomever is nominated will face hearings and must win approval by the Senate — which could be a drawn-out process in DC’s tense political environment.

Will his legacy survive? 

Known for his balanced approach to policy, Gottlieb not only dished out criticisms to Big Pharma, he also worked alongside the industry to reform key policies. In particular, Gottlieb set the stage for the FDA’s record number of new and generic drug approvals. And he is known as a champion of innovation, who helped usher in the approval of first-of-its-kind gene therapies. 

Will the agency maintain its hastened pace once he’s gone? Many in the industry hope so. The CEO of Alnylam Pharmaceuticals, John Maraganore, said that he is sad to see Gottlieb go but that he also expects the FDA will maintain its commitment to supporting innovation. 

“[Efforts to] modernize the FDA (e.g., FDASIA, 21stCentury Cures) actually began prior to Scott’s arrival, so we fully expect the FDA’s approach to our industry’s innovation to continue without change,” he stated. 

Others have noted that Gottlieb is leaving the agency fully staffed with enough experts to continue his efforts to increase drug approvals after he’s gone.