Gottlieb Set a New Bar – What Happens Now?

The news that Dr. Gottlieb was leaving his post as Commissioner of FDA took everyone by surprise. Perhaps another surprise to many was the skill and judgment he brought to the job when initially he faced many critics due to his ties to the pharmaceutical industry. Yet of the many names floated at the time for the post, he was clearly the most qualified – offering the perspective not only of a doctor, but as someone who fought cancer, as a patient as well. And he brought experience. He was not new to FDA having served as a Deputy Commissioner under Mark McClellan. During that time, one would imagine that he devised a blueprint for how he would do the job were he Commissioner. When he actually became Commissioner, he went about implementing that blueprint.

But while detractors expressed concern over pharmaceutical company ties, as Commissioner it became apparent that what you saw with Dr. Gottlieb was what you got. Over the years as a Resident Fellow at the American Enterprise Institute he wrote extensively in national publications opining on a number of themes that were ones he would eventually bring to the job. In the grand picture, he looked at an agency that some may have said had become so entrenched in process that it lost sight of the goals for which it existed. The idea that everything should be done according to the same process it had always been done challenged progress. He embraced mechanisms that might loosen that up. Many of the policies that came about as FDA Commissioner he wrote about as themes in the years before.

For example, the idea of rolling submissions of BLAs and NDAs offered a means for companies to make progress in the development of new drugs at a faster pace. The tenure of Dr. Gottlieb as Commissioner is characterized by the notion that resources were best used in a way that maximized impact when it came to development and in the area of safety, focused on those areas where there was the most risk, rather than spread resources evenly across the risk spectrum. To that end, across a broad spectrum of development, there has been change effected in the way the agency is going about its business – from the faster development of generic drugs to new heights in the approval of new molecular entities.

Also during his time at FDA, the agency oversaw approvals of huge steps forward, particularly in oncology.

He has also not been shy to tackle large issues – vaping among youth and the opioid epidemic.

Moreover, he has not kept what he was thinking and doing a secret. Dr. Gottlieb is someone I’ve known for a long time and he always liked to talk. But as Commissioner, just as he did during his days at the American Enterprise Institute where he frequently published his opinions and ideas, he continued to do so through the issuance of “Statements from the Commissioner”. These were not one-offs. Rather there were topics, such as the development of a response to the opioid epidemic to the pursuit of more generic approvals to the development of pathways to speed the regulatory oversight over the approval process for new therapies, whereby he marked progress and communicated to stakeholders not only what was happening, but much of the reasoning behind it. Whereas past commissioners relied on a more reactive means of communications – providing updates during Congressional testimony and speeches for example, he took more of an initiative to be proactive. In doing so, he did it not only broadly speaking – on a range of topics, but with depth as well.

All of this changed what we have come to expect of someone heading FDA. The question becomes – now what? As he leaves the office, he demonstrated that one can have vision, ideas on how to execute that vision, and ability to do it when needed, all the while communicating transparently about it. He came to the office having had a long time to think about the role beforehand and he was effective in making change that had a positive impact. In addition, he is a snappy dresser. One hopes there is a similar presence that can keep the bar where it has been set.

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