Vape Friendly FDA Commissioner Confirmed
The Trump Administration’s pick to head the United States Food and Drug Administration, Dr. Scott Gottlieb, has been confirmed to the position of FDA Commissioner.
Vaping Post is reporting that Gottlieb, who has had detractors and supporters on both sides of the aisle, was confirmed on Tuesday by the Senate and is expected to take up the post as soon as possible.
The confirmation comes as a relief for the vaping industry, as it has high hopes that Gottlieb will carry through on President Donald Trump’s campaign promise to roll back regulations to make it easier for small businesses, like the ones found in the vape industry, to thrive. It is also thought that the new FDA Commissioner might do more than just roll back some regulations; it is possible he could go as far as reversing the agency’s deeming rule that led to vaping being categorized as a tobacco product with the same regulations.
However, detractors are upset that Gottlieb’s nomination was confirmed, especially considering his ties to drug companies, vape companies, and the fact that he has been non-committal about some issues that concern anti-vaping advocates, like candy-flavored vape liquids. Gottlieb was also criticized for his involvement with a vape company, a business that he has since divested from in order to quell the discontent.
Let’s take a moment to look closer at Gottlieb and why so many in the vaping community see him as vaping’s best hope for an advocate within the Trump Administration.
Dr. Scott Gottlieb earned his bachelor’s degree at Wesleyan University before attending Mount Sinai School of Medicine. Between his undergraduate and graduate degrees, he worked as a healthcare consultant for the investment bank known as Alex, Brown and Sons. He is a clinical assistant professor at the New York University School of Medicine, an internist at Tisch Hospital in New York, and is a resident fellow at the conservative think tank American Enterprise Institute.
Gottlieb has served the American government in a number of capacities since 2005, most notably as the Deputy Commissioner for Medical and Scientific Affairs at the FDA; he also held roles as a senior advisor to the FDA Commissioner as well as the Director of Medical Policy Development at the agency. He was also a member of the White House Biodefense Working Group, a group dedicated to preparing and planning countermeasures in case of a biological attack.
Prior to his confirmation for the role of FDA Commissioner, Gottlieb served on the editorial board of the Food and Drug Law Institute’s publication, Food and Drug Policy Forum.
Now that Gottlieb has been confirmed by the United States Senate, he will be required to recuse himself: “for one year from any agency involving about 20 health care companies he worked with” under an ethics agreement to ensure that the commissioner is not biased about any rules and regulations that may hinder these companies. The list of companies Gottlieb has worked with as a consultant include New Enterprise, Glaxo-Smith-Kline, and Bristol-Meyers Squibb.
He will also be required to divest from any and all businesses relating to food and drug companies that he may be aligned with, including vape companies.
While his confirmation covered a lot of different topics, it’s important to note that when it comes to vaping, Gottlieb has had a measured and reasonable response to the regulation and health of the industry. He has written about this extensively, most notably in 2014, for which he penned a piece for Forbes on the very subject.
He stated then that: “[The] FDA was to create a path to enable cigarette makers to transition away from smoked tobacco and win government approval of consumable products that used tobacco but presumably harboured less, and perhaps even none of the health risks posed by smoking. When this quid pro quo was pushed through Congress, the industry’s critics and allies each positioned it as a win-win. But it was dependent on FDA being able to establish – and maintain – a regulatory path that let tobacco get approval for new products that posed a “reduced harm” over traditional smoked cigarettes.”
It is clear that Gottlieb has the best interest of the public at heart, which is reassuring, considering the lengths that Congress and other politicians have gone to in order to shut down the industry entirely, starting with the false notion that vaping is somehow as dangerous as smoking.
This assertion, however, has been borne out by scientific study to be incorrect, as this publication has discussed at length over the past year. In fact, America’s closest ally, the UK, has empowered its businesses to provide vaping as a smoking cessation method under law, a move that was supported by Public Health England’s research that found that vaping is 95 percent less dangerous than smoking.
The FDA Commissioner will have a lot to consider in terms of what he will do about vaping, considering that the FDA’s deeming rule on the regulation of vaping products as tobacco products has already been implemented into law. That deeming regulation will lead to, as this publication has spoken about before, vape businesses to be responsible for millions of dollars worth of application and legal fees for the mandatory PMTAs that will be required by August of 2018.
To add to that, many states have already decided to tax vape products at the same level as tobacco products with some states, like Pennsylvania, deciding to implement a wholesale tax that would burden vape suppliers and hurt the economy in the state.
It will be up to Commissioner Gottlieb to determine whether or not the vape industry has been the victim of overregulation; if he decides it is, then there is a chance that the industry will be able to come to an agreement about vaping regulations with the government, allowing for businesses to flourish while maintaining strict regulations for the safety and security of the public.
Only time will tell what the new FDA Commissioner will do about the fate of vaping in the country.