FDA Commissioner Scott Gottlieb Amps Up Public Visibility, Effectiveness
Its not often one sees a federal agency head double the output of news releases and, according to Fierce Pharma, put out 53 policy statements in the first half of 2018 — up from just 4 during the same time period last year.
That’s impressive by any standard.
“What it means for pharma, and for all other stakeholders, is those statements are providing a lot more context and rationale for FDA actions,” says Mark Senak, who tracks FDA communications activities.
But what it spells out in the long run is, first, there is a lot more context than would be provided in a normal press release about an action being taken by the FDA, and second, it gives stakeholders additional context over time.
Imagine that: an FDA Commissioner with something to say on agency policy views that’s also helpful to those he regulates.
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 know 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 piece 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.
The Trump Administration takes plenty of warranted hits about its dysfunctional nature, but public servants like Scott Gottlieb deserve enormous praise for his information offensive, which is helpful to consumer and industry alike.