Scott Gottlieb, the commissioner of the Food and Drug Administration, will leave the office after a tenure of 23 month.
I’m immensely grateful for the opportunity to help lead this wonderful agency, for the support of my colleagues, for the public health goals we advanced together, and the strong support of @SecAzar and @realDonaldTrump – This has been a wonderful journey and parting is very hard. https://t.co/1Zu9y7NTwR
— Scott Gottlieb, M.D. (@SGottliebFDA) March 5, 2019
In a previous post, I listed some of the agency’s innovative approvals during the past two years under Mr. Gottlieb’s lead. The departure of the head of this crucial regulatory body will negatively impact the overall (biotech, pharma, medical devices, etc.) industry. (possible slower, less innovative approvals)
What seems odd here: 1. Mr. Gottlieb publicly has said in January on Twitter: “I want to be very clear — I’m not leaving. We’ve got a lot important policy we’ll advance this year.” 2. Mr. Gottlieb was working throughout the morning
There should be an increasing intensified pressure from industries that are experiencing headwinds due to his policies and the end users/stakeholders that are complaining about some current situations (but not in total control of FDA I believe), such as opioid abuse, prevailing of e-cigarettes among teens, etc.
Some of topics he is intervening include: 1) brand drug companies withholding samples needed by generic drug makers 2) rebate traps and other anti-competitive abuses in the pharmaceutical supply chain 3) rising use of electronic cigarettes (e.g. JUUL Labs).
[Warning Letter from FDA to JUUl Labs]
Last December, Altria invested $12.8 billion into JUUL for a 35% ownership. JUUL projected revenue of $940 million in 2018, with gross margins of 70 percent, and its 2018 projected EBITDA approximately $250 million. [Crunchbase News]
(So assuming 100% growth -> 1.84 billion in revenue in 2019, it’s valued at ~20.0x revenue multiple)
Last year, FDA issued more than 1,300 warning letters and fines to convenience stores, gas stations and other stores over the summer for selling e-cigarettes to minors, Gottlieb says. The FDA says it’s the agency’s largest such action in history. [npr.org]
Mr. Gottlieb also planned to seek a ban on menthol cigarettes.
Mr. Gottlieb has received criticism for the approval of Dsuvia, a powerful opioid painkiller.
Update on March 6: Tobacco giants’ stocks rising…
- Altria Group Inc (NYSE: MO)
- British American Tobacco PLC (NYSE: BTI)
