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J.P. Morgan Healthcare Conference: FDA Speaks

January 9, 2019
By Mark Senak

Yesterday Commissioner Scott Gottlieb was to take the podium to address attendees at the J.P. Morgan 36th Annual Healthcare Conference being held in San Francisco.  Unfortunately, due to the current government funding impasse, he did not make it. But had he been there, it is fair to say that he would have had a lot to say. In the past one and a half years since he became commissioner FDA has seen many “firsts”- the first “smart pill” that can track patient adherence, the first time that the immune system has been harassed to fight cancer, the first prescription mobile app, to name only a few. Also in the course of the past year, FDA set new records in approving not only new molecular entities but also generic drugs.

It is evident that Dr. Gottlieb’s tenure at FDA has represented substantial change – not only in what the agency is doing, but in the way it is doing it. Implementation of the 21st Century Cures Act coupled with a long-standing conviction in modernization approaches that could speed up new approvals, support innovation and, as he has often said, do so without compromising the agency’s gold standard for safety.

But it is another significant change at FDA –the way it communicates agency milestones and policy direction – that might be overlooked. With past FDA Commissioners, it was a relative rarity to issue special statements to the public. The office of the Commissioner had a public face only insofar as it could be perceived from public testimony before Congress or from speeches like the one he is delivering to the J.P. Morgan Healthcare Conference. That is no longer the case.

In 2017, FDA issued a total of 164 press releases, which was more than the year before when 122 were issued. This year, FDA dwarfed that number by issuing 289 press releases, or on average 24 a month. Moreover, the primary driver of the increase came from the Commissioner himself. Of the 2018 releases by FDA, nearly 44 percent were made up of Special Statements from the Commissioner – or about 2 such statements on average a week. Not only have agency communications become more frequent, they are more personalized and represent a seismic shift in style and content.

The topics of those special statement not only mark milestones for the agency – special new approvals, e.g., but they also signal developing policy along a wide spectrum. He stakes out direction. Perhaps no other area saw more comment from him than did that of matters related to the opioid epidemic. He has also made an effort to signal his thinking for the e-cigarette industry. In short, when there is an emerging policy matter that is important, he is not waiting for the opportunity to provide testimony or outline his thinking in a speech, nor through the issuance of warning letters –  he is doing it in real time. That represents a big change for FDA and for the way the industries it regulates to understand policy development within the agency.

It is not only in his liberal use of special statements, but also his use of social media. Twitter, which the agency was slow to embrace, is now liberally used by various offices in the agency and the Twitter feed of the Commissioner has been one of the primary means for getting information about how FDA is operating during the current government shutdown. Since December 21, he has issued dozens of tweets, often as a string, to provide updates and clarify what the agency will be doing and what it will not.

The change in communications represents more than a counting game. It provides a real insight as to where policy is headed, but also with reasoning as to why it is going there. Up until these statements, FDA delivered facts. Now the Commissioner adds reasoning and thinking to the mix.

Finally, FDA has become not only a more robust playing field in terms of communications, but has become a more “real-time” regulatory body.  The agency has joined the ranks coming to the realization that providing information and reasoning to the industries it regulates actually benefits that oversight, and does not hinder it. That does not mean that Dr. Gottlieb’s words from the podium at this conference are not worth listening to – he is also a prolific speaker – but it does mean that when we hear those words, if we have been listening between the speeches, we will have a good idea of the directions in which we are going. Everyone wins.