– On March 5, Gottlieb sent his notice of resignation to the Secretary of the Department of Health and Human Services saying that he would leave office in a month’s time.
– His tenure has seen increased regulation on tobacco products and especially e-cigarettes.
– The FDA attributes the increased regulation to widespread access of nicotine products by the youth.
– Under Gottlieb, the FDA has already been trying to greatly help people quit smoking to cut back tobacco-related diseases and deaths.
– Biopharma companies shed points on the stock market which indicates that Gottlieb had been supportive of them.
– Big tobacco gained on the stock market that could be an indicator they hope the incoming FDA Commissioner might be lenient on the regulatory regime.
Scott Gottlieb, who has done an absolutely terrific job as Commissioner of the FDA, plans to leave government service sometime next month….
— Donald J. Trump (@realDonaldTrump) March 5, 2019
In a move not foreseen by many, Commissioner Scott Gottlieb has resigned. On March 5, he sent a letter to the secretary of the Department of Health and Human Services, Alex Azar II, informing him of his intention to vacate office in a month’s time. The FDA boss has been around office for under two years since assuming his role in May 2017.
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
When tendering notice of his resignation, Gottlieb cited the much time spent to travel to Connecticut which denies him ample time with his family as his reason for standing down. At the start of the year, Gottlieb had denied rumors he was planning to resign.
Before his appointment to the FDA, Gottlieb has been a venture capitalist and a scholar at the American Enterprise Institute. He was the winning choice over two other Silicon Valley entrepreneurs who’d little experience in matters pharma.
During the time, those in opposition to his appointment cited his deep connection to the pharmaceutical industry. He, however, focused on divest from the industry.
His departure from the agency is unlikely to affect normal operations such as policy drafting and drug approvals. The only real downside could possibly be on the stakeholders who admired his leadership and the personal views he held on different matters.
As an example, the biopharmaceutical stakeholders praised his intentions hasten the reviews of generic and innovative agents. This might be, perhaps, the reason why both the S&P pharma and the Nasdaq biotechnology indices shed some points after Gottlieb’s resignation was announced.
Graham Parry, a research analyst at Merrill Lynch who covers the sector, told clients late Tuesday that… https://t.co/d4Z5BmtlZr
— OR4HealthChoice (@OregonVacTruth) April 7, 2019
Will this improve the situation with vaping restrictions?
Investors are apprehensive that Donald Trump could replace Gottlieb by having an outsider who’d reverse a number of the achievements made by Gottlieb at the agency.
There’s also a fear that the incoming commissioner could improve the bar too much for drug approvals after a period of relative leniency that’s been there during Gottlieb’s tenure.
Gottlieb’s greatest and widely acclaimed legacy will soon be his stand on tobacco regulation notably the issue of e-cigarettes. In fact, the stock market was upbeat for big tobacco as Altria and British American Tobacco gained two percent on the headlines that Gottlieb was because of resigning.
This was a great impression that the FDA hasn’t been taking matters prone to the tobacco industry. A perceived his actions as rather drastic and that the regulations were not favoring their businesses.
He’s initiated the development of many policies touching on tobacco with much of the emphasis being on tobacco products especially e-cigarettes. His tobacco regulation roadmap appeared to possess been the first thing he used when he assumed office. Barely two months into his tenure, in July 2017, the agency unveiled the FDA’s Comprehensive Arrange for Tobacco and Nicotine Regulations.
— Peter Baker (@peterbakernyt) March 5, 2019
The struggle with e-cigarette manufacturers began this past year when it had been established that there was an alarming rise in the number of kids using e-cigarettes.
At the center of these unfortunate findings was Juul Labs, the San Francisco based company that manufactures JUUL e-cigarettes. It was learned so it had become very easy for the children to access the e-cigarettes from retail stores and from online shops.
Another factor which was making kids pursue e-cigarettes was that the merchandise was appealing. As an intervention, the FDA announced a proposal aimed at preventing access to flavored e-cigs and a complete ban on menthol cigarettes.
There have even been requiring the FDA to rescind its earlier decision that found it extend the time scale within which e-cigarette companies would apply for approval of these products from 2018 to 2022.
However, in defense, the FDA said that the extension was meant to give the FDA and Congress ample time and energy to come up with inexpensive and less tedious pre-market approval procedures that would not drive vaping companies out of business.
The many e-cigarette regulations that Gottlieb has overseen while at the FDA, have already been mainly to keep the merchandise from kids which may lead to nicotine addiction.
It now remains to be seen whether another FDA Commissioner will sustain the e-cigarette campaigns that Gottlieb started. The gain in the share prices of both British American Tobacco and Altria indicate that the tobacco industry investors are hopeful that the new boss could be more lenient in terms of the regulatory regime. Some vapers supported his intentions while others felt he had been unnecessarily strict.
On one other hand, anti-tobacco activists are likely to be hoping to see someone who’ll continue steadily to implement the comprehensive tobacco plan that Gottlieb has been rolling out.
It could not matter who succeeds Commissioner Scott Gottlieb. What matters is that he should be replaced with someone who will look after the healthiness of the American people just as Gottlieb was trying to do. Many people agree totally that teenage vaping must be prevented by all means possible, lest we are faced with a generation grappling with nicotine addiction.
This kind of possibility would have been a disaster given the countless diseases due to tobacco products. This might lower productivity and cost the taxpayers medical costs running into an incredible number of dollars.