Behold the Revolving Door: Gottlieb Joins Pfizer

After leaving his job as FDA commissioner, Scott Gottlieb has accepted a part time position to help pay the bills. The ex-FDA boss has been elected to the board of directors at Pfizer Inc., manufacturer of the quit-smoking drug Chantix and the third largest pharmaceutical company in the world.

The move surprised almost no one. According to STAT News, during the last 38 years every FDA commissioner but one (David Kessler) served on a pharma board after leaving public service. And why not? Who would be more attractive to a company that sold more than $53 billion worth of drugs in 2018, as Pfizer did, than someone who until a few months ago created FDA policy and intimately knows the regulatory strategies of the Trump administration? Gottlieb will also serve on the board’s regulatory and compliance and science and technology committees.

For conspiracy fans, Gottlieb is joining the pharma company that makes the world’s best selling non-nicotine quit-smoking medication. Pfizer markets varenicline in the U.S. as Chantix, and elsewhere in the world as Champix. Vapor products are in direct competition for smoking customers with Chantix, and they’re cheaper, more attractive to smokers, and not known for creating suicidal thoughts and nightmares.

Chantix is usually covered by employer-provided health insurance, which makes it largely useless for many of the low-income, uninsured people who smoke, since the cost without insurance is about $500 a month. Luckily for Pfizer, there are still enough insured smokers who want to quit to drive about $1 billion in annual Chantix sales.

Gottlieb’s July 2017 announcement of a “comprehensive plan” to remake the tobacco and nicotine landscape got attention mostly for the plan to reduce nicotine in cigarettes below addictive levels, and for the postponement of the PMTA deadline for vapor products (which was recently reversed by a federal judge in Maryland). But he also called for help from pharmaceutical manufacturers and vowed to “work to have medicinal nicotine and other therapeutic products play a greater role in helping more smokers try to quit with help.”

Then came the JUUL moral panic. Tobacco control and anti-drug groups worked together to drive the popular perception that huge numbers of high schoolers were vaping and becoming nicotine “addicts.” Never one to miss an opportunity for publicity, Gottlieb made the panic his own, called it an epidemic, and beat the addiction drum incessantly for his remaining months at the FDA.

Since then, Gottlieb has spoken several times about vaping products possibly being approved through the medicinal route, as over-the-counter (OTC) drugs. (He has even pushed the idea of novel drug products to treat “adolescent nicotine addicts.”) Pharmaceutical approval wouldn't likely be a process accessible to small independent vaping manufacturers (or even larger ones, except possibly JUUL and NJOY). According to vape industry regulatory attorney Azim Chowdhury, drug approval would most likely accomplished by drug companies only.

“If FDA does establish an OTC pathway for ENDS, pharmaceutical companies with prior experience navigating the complex and costly FDA drug approval process for NRTs, and whose products are competing with recreational ENDS on the nicotine market, would certainly be better positioned to navigate that regulatory scheme compared to the thousands of small businesses that make up the vaping industry today,” Chowdhury wrote last year.

That would include a company like Pfizer, which is built for the drug approval process. Pfizer has the regulatory chops, the money, and the patience to wait years for approval of a mediocre e-cigarette it could sell in pharmacies, but also in convenience, grocery and big box stores. Once the FDA completes Gottlieb’s work and bans flavors in consumer vaping products, a pharma vape would have less competition (no vape shops and no flavors in c-stores), and could be a useful complement to Chantix.