When the FDA talks, pharma listens. But what happens when the FDA talks way more than usual? We're finding out now, thanks to FDA Commissioner Scott Gottlieb and his torrent of public statements.
The agency has more than doubled the number of press releases it sent out in the first half of 2018, with 126 press releases so far compared to 52 last year. But the most notable increase has been in Commissioner Statements. FDA Commissioner Scott Gottlieb put out 53 statements in the first half of 2018, up from just four during the same time period last year. (Gottlieb was sworn in as FDA Commissioner in May 2017.)
Eye on FDA blogger and public relations professional Mark Senak, who first pointed out the uptick in chattiness in a recent blog post, wrote, “What does he talk about? Everything.” And it’s not just formal statements—in June, Gottlieb began posting a weekly Sunday tweetorial from @SGottliebFDA.
However, the increase in communications, while not typical for the FDA, doesn’t just mean a busier PR staff. Industry players, including pharma companies, can likely pick up some helpful guidance on FDA direction and thinking with the increase in official communications.
“What it means for pharma, and for all other stakeholders, is those statements are providing a lot more context and rationale for FDA actions,” Senak said in an interview with FiercePharma. “…What it spells out in the long run is, one, there is a lot more context than would be provided in a normal press release about a certain action the FDA is taking, and two, it gives stakeholders additional context over time.”
While Gottlieb has tackled a wide range of subjects from cannabis research to, more recently, the risks of vaginal rejuvenation, he has also regularly focused on some issues such as the opioid crisis, e-cigarette use and drug development, including a push for more generic drugs.
Drugmakers certainly know, for instance, that Gottlieb’s FDA is tackling drug pricing in part by promoting generic drug availability as a way to push price competition and patient access. But in one 2,500-word treatise in February, he laid out specific initiatives and detailed FDA thinking about continuous manufacturing, outsourcing facilities for compounding drugs, developing medical devices, expanding use of real-world data and revamping generic drug review.
“There’s no way to assess how impactful they are, but on one hand, more information is always a good thing. It provides more transparency and you really get to see how Scott’s mind works,” said Senak, who worked with Gottlieb 20 years ago. He noted that Gottlieb’s loquacious reign as FDA chief is well in character, as he knew him even then to be “engaging, thorough and thoughtful” during long work conversations.
Still, on the other hand, is too much just too much? Senak said, “It’s not an unreasonable observation to say with so many of them, do they lose some of their effectiveness? I don’t think we know the answer to that.”