The event was originally schedule to be a hearing by the dry appropriations subcommittee on the FDA budget. But Gottlieb had other plans.
Former George W. Bush health official switched to the topic of his plans to address REMS abuse. In which pharmas are accused in slow-walking to provide generic companies with samples to make cheaper copies, generic companies are accused of using them as a way to get these samples. He also showed a proposal to list patent drugs without generic competition.
Some expected that the newly-minted Commissioner would send a deputy, but instead the hearing turned into a news-making discussion between Gottlieb and members of Congress on the controversial topic drug pricing.
“I was surprised he agreed [to the hearing], astounded at what he had said and since then, have been running trying to keep pace with what he’s doing,” Ladd Willey, executive director of Alliance for a Stronger FDA told BioPharma Diive. This group includes stakeholders from industry, patient groups, and other stakeholders.
This was an example of Gottlieb’s proactive communication with the public, and industry about the FDA’s priorities and work.
Gottlieb had sent the first of thousands of tweets to @SGottliebFDA a few days prior to that meeting. He was setting the foundation for his interaction and engagement with the public as commissioner.
Sources told BioPharma Dive that Gottlieb has been in the forefront of the FDA’s race for leadership more than a year after his tenure began. One Twitter analysis service reported that Gottlieb has averaged more than 14 tweets per day on his Twitter account in 2018, which is roughly 400 tweets per month. In July, he set a personal record with 554 tweets.
They are not some GS-13 in foreign affairs. They are what Scott Gottlieb Twitter thinks about on a specific day, and that is really unique and really fascinating.”
The agency regularly publishes statements directly from its commissioner, in addition to Twitter. Gottlieb published 55 statements during the first seven months 2018, more than one per day, and had 56 total.
Gottlieb stated in a statement to BioPharma Diive that he considers FDA’s communications a key component of its public health missions.
“It’s important that we make policy transparently, share our goals and invite public comment and scrutiny,” Gottlieb said. “Communication activities on platforms (including social networks) reflect both our rapid legislative initiatives that reflect new opportunities for us to move forward and through scientific advances.”
Gottlieb has praised by both insiders and outsiders for its transparency and efforts. A recent survey by FDA scientists found Gottlieb a positive force within an administration that was downgraded by federal scientists. Gottlieb’s willingness to stand up for his agency’s work may explain the support he has received from rank-and-file.
was interviewed by Josh Sharfstein, ex-FDA principal deputy commissioner under the Obama administration. The FDA has a lot of policy. The FDA is a hub of science. His social media presence is not just window dressing. It helps people get to know the FDA.
was also an adviser to Henry Waxman, the former Democratic Representative. While he sometimes criticized FDA policy decisions but he supports Gottlieb’s approach to communications, Gottlieb supported it.
He said that the FDA’s commissioner was proud to be promoting their social media work in ways that were not possible before. “He is generally like by scientists at the FDA. This is a remarkable feat in this administration.”
Sharfstein was referring to the Union of Concerned Scientists’ recently released survey of scientists at 16 federal agency, including FDA. It was found that FDA scientists are happier than their counterparts at other agencies.
FDA morale has not dipped since previous commissioners — in fact, the agency had the highest percentage respondents choosing “excellent” or ‘good” when compared to the three previous iterations of this survey, published in 2015 and 2010.
Walid Gellad is the director of the Center for Pharmaceutical Policy and Prescribing, University of Pittsburgh. He wrote to BioPharma Dive in an email that he appreciated Gottlieb’s efforts to inform the public but also saw a risk from the constant stream of communications.
He wrote that “shouldn’t distract people from considering areas of FDA policy that he’s not talking about.” “here is a potential problem if people only focus on the public statements and ignore any turmoil in the background.
Gottlieb is generally a high-scoring candidate. But critics worry that he might push too much regulatory flexibility. Something that may not be apparent in his tweet comments about streamlining clinical trials.
Gottlieb also engages in Twitter conversation with reporters, exchanging barbs and occasionally cracking jokes. One instance was when he tweeted a picture of himself on a farm wearing tight jeans. This provoked some hilarious responses from Twitter. Gottlieb responded to one tweet, arguing that the 2% of elastane was beneficial for mobility and comfort.
Sharfstein said that this type of engagement by a high-ranking official is quite new.
Sharfstein stated that he couldn’t use his Twitter account when he was there less than a decade ago, during the Obama administration. Gottlieb posted a comment on Scott Gottlieb’s twitter, saying that “now” he was tweeting about his skinny jeans.
