Scott Gottlieb dice adios, firma y promete...

Scott Gottlieb signed off from his remarkable but brief tenure as FDA commissioner yesterday, completing his final week with a series of announcements across priority areas.

Gottlieb has served less than two years in the post, but has proven to be one of the most energetic, reforming and outspoken FDA commissioners in recent memory, earning praise from politicians, regulators and the pharma industry for his leadership.

This was based on Gottlieb’s bold approach to addressing unnecessary barriers to innovative medicines approvals, while at the same time tackling bottlenecks in generic drug approvals and pricing and competition issues, including ‘naming and shaming’ companies which obstruct generic competition.

He now hands over to interim FDA commissioner Ned Sharpless, formerly head of the National Cancer Institute (NCI), but ended his final days in the post with a redoubled focus on key issues. These included 

• .promoting AI-based medical devices, 
• .new regulatory pathways for cannabis-based medicines, 
• .combating illegal online sales of opioids, 
• .renewing efforts to cut smoking and tobacco use, and 
• .bringing competition to US insulin markets. (...)

These remarks add to commentary Gottlieb made on the wider question of competition and drug prices last week at a Alliance for a Stronger FDA meeting last week.

Talking in a ‘fireside chat’ with former FDA commissioner Mark McClellan, Gottlieb commented on the ongoing debate about how the US should control its drug prices.

He said he believed area there should be price competition in Medicare Part B, which covers medicines dispensed in the doctor’s office.

"The government is largely a price taker [in Part B] and those drugs aren't competitively bid; I think we need to think about that," he said.

This would once have been a radical view for anyone in the US, let alone for a politically-appointed FDA commissioner, but the drug pricing debate has moved on during the Trump presidency and in Gottlieb’s tenure.

Asked to comment further, Gottlieb demurred on this occasion, but concluded: “Well, I’ll have a lot more to say on that in about seven days”.

Losing Gottlieb’s dynamism, FDA-watchers are also concerned that it could take a long time for a permanent successor to be appointed, as the Trump administration has a poor record in filling many senior posts across government. However, in Twitter exchanges with his immediate predecessor Robert Califf and new commissioner Sharpless, the emphasis was on continuity.

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