BY ANGELA GARRITY
Illustrations by Erik Deangelis
For years the vaping industry has lived with Scott Gottlieb talking out of both sides of his mouth, but could this week's Wall Street Journal opinion piece titled "The FDA's Challenge on E-Cigs" written by Gottlieb, and the CNBC headline of "Former FDA Commissioner Scott Gottlieb joins Pfizer's Board of Directors," expose the wolf in sheep's clothing that has always been lurking about? Maybe the answers have been there all along, but we just needed help to connect the dots of intention.
The first guidance released in August 2018, "Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products," focused on data recommended to evaluate potential toxicities associated with orally inhaled nicotine-containing drug products (such as e-cigarettes) to inform the FDA's assessment of a product's benefits and risks.
The development of an NRT drug was the first leg of a two-prong approach of the FDA's plan to "help smokers quit."
In late February, while still at the helm of the FDA, an additional draft guidance step was released. This second leg was in the effort to "helping smokers quit." Part of this plan included developing nonclinical testing of orally inhaled nicotine containing drug products (a novel device).
Particular interest and concern with a message enwrapped around this "novel device" was an FDA statement released from the then FDA Commissioner Scott Gottlieb, M.D., on additional steps by the agency to support the development of safe and effective novel nicotine replacement therapies to help smokers quit cigarettes:
Novel products with different characteristics or routes of nicotine delivery have the potential to offer additional opportunities for health-concerned smokers interested in quitting. This could also include products such as electronic nicotine delivery systems like electronic cigarettes, but which would need to be proven safe and effective for smoking cessation and regulated as a drug product. This would allow them to be marketed as a prescription or over-the-counter drug products with medical claims for smoking cessation or related indications – ultimately reducing the likelihood of someone continuing to suffer the clinical consequences of smoking. This is different from our regulation of e-cigarettes as tobacco products.
The FDA also stated:
Building on these efforts to encourage innovation of drug products to help more smokers quit cigarettes, today, we're releasing the second of two draft guidances aimed at supporting the development of novel nicotine replacement therapies that could be sold as new FDA-approved drugs, similar to current prescription and over-the-counter NRT drug products.
Fast forward to March 5, 2019, when the public learns that Gottlieb announced his resignation as FDA Commissioner, as reported by The Washington Post. The departure announcement shocked vapers and some FDA officials, whom state Gottlieb had recently hired senior staff and was aggressively pushing new initiatives. Gottlieb's reasoning: "to spend more time with his family." His signature issue, youth vaping, was being reviewed by the White House Office of Management and Budget, just as his resignation was publicly announced.
By early April, Gottlieb had departed as FDA Commissioner; however, neither the vaping industry nor the public had seen the sunset on him. Gottlieb returned to the American Enterprise Institute after his FDA departure, and in May 2019, he returned to New Enterprise Associates as a partner.
Gottlieb is a contributor and appears regularly on CNBC, as well as Twitter. Leaving the FDA has not halted his efforts to try to assert his influence on the court of public opinion about vaping.
On June 27, he announced via Twitter, "I'm honored to be joining the board of directors of #Pfizer and working together with more than 90,000 Pfizer colleagues to promote medical innovation, advance patient care, and secure access to better healthcare outcomes for families around the world."
If you haven't yet fully understood the grand scheme, let me break it down for you. Be concerned about this "novel device" Gottlieb told all of us about months ago because this is something that could truly decimate the industry. A big pharma (no PMTA required) owned, backed, and marketed "vape." He announced it as FDA Commissioner and is now on the Board at Pfizer. They don't need PMTA's to put this novel device out to "cure the epidemic" that was dreamed up because it will be a pharmaceutical (not deemed tobacco) product.
America, when are you going to wake up? You're being led by sensationalized headlines and greedy government officials, which will now lead to actual harm in the long run. There is a nonsensical state which has created a panic in this country using one word: "epidemic."
How is accepting a job on the board at Pfizer not illegal after heading up the FDA? Was there a required 90 day "cooling off" period in between the FDA and Big Pharma? Maybe Scotty is better served as the spokesperson for those fabulous socks he wears, as he seems to be best there. Someone get him a sponsorship.