Just two weeks after the Senate confirmed Scott Gottlieb as the next Food and Drug Administration commissioner, he returned to face Congress.
The event was slated to be a dry appropriations subcommittee hearing on the FDA budget — but Gottlieb had other things in mind.
The former health official in George W. Bush's administration shifted topic to his plans to address abuse of the REMS system, in which pharmas are accused of slow-walking providing samples needed by generic companies to develop cheaper copies. He also previewed a proposal to list off-patent drugs with no generic competition.
The May 2017 hearing, where some expected the newly-minted commissioner to send a deputy instead, turned into a news-making debate between members of Congress and Gottlieb on the controversial topic of drug pricing.
"I was surprised he agreed to [the hearing], astounded by what he had to say and ever since then, I've been running trying to keep up with what he's doing," Ladd Wiley, executive director of the Alliance for a Stronger FDA, a group that includes stakeholders from industry and patient groups, told BioPharma Dive.
It was a preview of Gottlieb's proactive approach to communicating with the public and industry on the FDA's work and priorities.
A few days before that meeting, Gottlieb sent the first of the now thousands of tweets from @SGottliebFDA. He was laying the groundwork for how he would interact and engage the public as commissioner.
Now, more than a year into Gottlieb's tenure, the race to keep up with the FDA leader has only quickened, sources told BioPharma Dive. On his well-known Twitter account, he's averaged more than 14 tweets each day in 2018, or roughly 400 per month counting retweets and replies, one Twitter analysis service reported. He set a personal record in July with 554 total tweets.
"They are not some GS-13 in external affairs. They are what Scott Gottlieb is thinking about on a particular day and that is really special and really interesting."
Ladd Wiley, on Gottlieb's tweets
Executive Director, Alliance for a Stronger FDA
In addition to Twitter, the agency routinely publishes statements directly from the commissioner. Gottlieb had 55 such statements in the first seven months of 2018, or more than one every four days.
Gottlieb said in a statement to BioPharma Dive that he views FDA's communications as a key feature of its public health missions.
"It’s vital that we formulate policy in a transparent way, share our goals, and invite public comment and scrutiny," Gottlieb said. "Our vigorous pace of communications activity across platforms (including social media) is a reflection of the legislative initiatives we're charged with advancing, as well as the opportunities offered by new scientific breakthroughs.”
More than window dressing?
Stakeholders both inside and outside the agency have given Gottlieb credit for both transparency and effort.
Among current FDA scientists, a recent survey found Gottlieb a positive force in an administration rated poorly by most federal scientists. His eagerness to publicly stand by his agency's work could be part of explaining the rank-and-file support he's received.
"Twitter is far from everything," Josh Sharfstein, former FDA principal deputy commissioner during the Obama administration, told BioPharma Dive in an interview. "There's a lot of policy at the FDA. There's a lot of science at the FDA. But I think his social media presence is more than window dressing, because it helps people understand the FDA."
Sharfstein was also an aide to former Democratic Rep. Henry Waxman, and while he's occasionally criticized FDA policy decisions, he supported the approach Gottlieb has brought to communications.
"People at the FDA are proud the commissioner is out there touting their work on social media in ways that really weren't possible before," he said. "He's generally well-liked by the scientists of the FDA, which is no small feat in this administration."
Sharfstein was referencing the recently released Union of Concerned Scientists' survey of scientists at 16 federal agencies, including the FDA. It found FDA scientists are generally happy, especially in comparison to their counterparts at other agencies.
Additionally, FDA morale hasn't dipped from previous commissioners — the agency actually had the highest percentage of respondents selecting "excellent" or "good" compared to the previous three iterations of the survey published in 2015, 2010 and 2006.
Policy via Twitter
More substantively for industry, Gottlieb has used Twitter and other social media not just to highlight FDA accomplishments, but also to preview guidance and other policy.
These are disseminated by Twitter threads of dozens of messages that have signaled FDA priorities on some of the most pressing issues.
One self-described "tweetorial" from last month, running the same length as an editorial, argued that continuous trials "can save time, lower costs and reduce the number of patients." Gottlieb even instructed his audience "to look for new guidance soon from #FDA on how developers can conduct these 'expansion trials.'"
In another from last month, Gottlieb shared his perspective on combating the opioid crisis. The thread included charts, graphics, links to FDA officials, research, Senate subcommittee reports and agency statistics.
Still, there are risks to the volume and pace of Gottlieb's methods.
Walid Gellad, who runs the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh, wrote in an email to BioPharma Dive that while he appreciates Gottlieb's focus on informing the public, he also sees a general risk going forward from the flurry of communications.
"[I]t shouldn't distract people from looking at areas of FDA policy he's not talking about," he wrote. "[T]hat is a potential downside if people focus only on the public statements while ignoring any tumult in the background."
And while Gottlieb has generally scored high marks, critics have worried he may push regulatory flexibility too far — something that may not come to the surface in tweeted comments on streamlining clinical trials.
On the other side of his Twitter engagement, Gottlieb has exchanged barbs with reporters and even cracks the occasional joke. In one instance, he tweeted a photo of him on site of a farm in a pair of particularly tight jeans, which stirred up some playful responses from Twitter. Gottlieb played along for the day, responding to one tweet arguing the 2% elastane helped with mobility and comfort.
I want to send a note thanking the Washington press corps for their collective fashion advice. I will take it under advisement. #skinnyjeans
— Scott Gottlieb, M.D. (@SGottliebFDA) September 1, 2017
That kind of engagement from a high-level official is relatively new, said Sharfstein.
When he was there less than a decade ago during the Obama administration, Sharfstein said he wasn't permitted to use his Twitter account, since it was still so new. "Now," he remarked on Gottlieb's Twitter, "he's tweeting about his skinny jeans."
