Scott Gottlieb’s FDA Legacy

The announcement last week took just about everyone by surprise. Scott Gottlieb, MD, the FDA’s well-respected commissioner, would be stepping down from that post within a month so he could spend more time with his wife and children. His announcement came as he is in the middle of a large-scale agency effort to combat teen tobacco and vaping use, as well as ongoing efforts to stem the country’s opioid epidemic.

Gottlieb has been the only FDA commissioner under the Trump presidency. When he was nominated for the position, many had reservations about Gottlieb in the role. After all, he had ties to several pharmaceutical companies and had spent many years at financial firms that made money by investing in health care companies. Many thought he would be cozy with pharmaceutical companies at the expense of patient safety and health. Some, however, saw him as a good choice since he served as an advisor with the FDA for two stints, the first from 2002 to 2003 and the second from 2005 to 2007.

As someone who has followed the FDA since 2005, when I first began my career as a healthcare journalist covering the pharmaceutical and biotechnology industries, as well as the FDA, I can say in my opinion, Gottlieb has been an above average commissioner. He has certainly been one of the more active people to have held the position. Nearly every day, Gottlieb releases long statements about issues that he believes are important to the FDA and the public.

Tighter Regulations to Cut Down on Teen Smoking and Vaping

His efforts to keep the public informed about what the FDA is doing is to be applauded. He is also the first commissioner in decades to aggressively tackle youth smoking. Over the last five or so years, smoking among teens has shifted from tobacco to e-cigarettes and vaping devices. His efforts to go after vaping manufacturers such as JUUL as well as seek to ban menthol cigarettes are a step in the right direction. However, Gottlieb faltered last year when he agreed to postpone new regulations for e-cigarette manufacturers to 2022 from 2018.

Gottlieb engaged in several efforts to ensure that prescription opioids are used only by those who need them and for relatively short periods of time. However, his agency erred, in my opinion, in its approval of Dsuvia (sufentanil), an opioid 5 to 10 times stronger than fentanyl and 500 times stronger than morphine. Amid a national opioid epidemic, I don’t see why this drug should have been approved.

Ramping Up Supervision of Supplements

The FDA under Gottlieb has also issued more warnings about supplements that are tainted with ingredients – including active pharmaceutical ingredients. Just last month, he announced that he was concerned with the growth of the supplements industry and signaled that modernizing the way supplements are approached by the agency may be warranted. With his imminent departure, whether anything will happen in this area is anyone’s guess.

Gottlieb has been praised by many within the pharmaceutical industry due to the sheer number of drugs approved under his tenure and often the speed of approval. Last year, the FDA set a record, approving 59 new drugs. Most of those drugs were approved through a type of designation that allowed for less review time, such as Fast Track or priority review. While this reduces the amount of time it takes for the FDA to evaluate a drug speeding a drug to market, the downside is that a fuller picture of a medication under review may not be known.

It is unclear who President Trump will nominate as the next FDA commissioner. It is a promising sign that National Cancer Institute director Ned Sharpless has been named acting head once Gottlieb departs.

Looking back at Gottlieb’s time at the agency, his replacement should be someone who will continue the progress he has made on lowering teen tobacco and vaping rates and will continue the fight to further regulate supplements and the battle against opioid abuse. But it should also be someone who will keep patients’ rights at the forefront and will ensure that drugs are only approved after a thorough review process.


Jonathan Block

Jonathan Block

Jonathan Block is a freelance writer and former MedShadow content editor. He has been an editor and writer for multiple pharmaceutical, health and medical publications, including BioCentury, The Pink Sheet, Modern Healthcare, Health Plan Week and Psychiatry Advisor. He holds a BA from Tufts University and is earning an MPH with a focus on health policy from the CUNY Graduate School of Public Health & Health Policy.


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One thought on “Scott Gottlieb’s FDA Legacy

  1. This man is a liar and a criminal who is guilty of racketeering.

    You make him sound like some family man, but he left the FDA to work at the biggest legal drug dealer in America and in the world, Phizer.
    He lied about the plant known as kratom, which is known to be a partial mu opioid aganoist and a safe treatment for opiate withdrawals, even the company he used to work at, GSK, knows this.
    So this man makes millions off of prescription opioids and he wants to make a plant that gets people away from opioids into a schedule one drug where it cannot even be studied by scientists, because, “it’s a dangerous opioid”?
    Why doesn’t he ban the fentanyl that he sells with Phozer? ( Not that he should, but his uneven judgements show his true motivation.) He is being dishonest and as with the way health professionals and ministers are lying about cannabis, a safe unpatentable medicine, these types of men don’t understand that , “the love of money is a root of all kinds of evil.”
    May the Lord Jesus Christ forgive them and show them that lying is destructive and unprofitable in the end. Amen
    Doctors and medicine makers are getting a very bad reputation because of their dishonesty and ignorance. Scott Gottlieb should be brought to justice for lying about kratom and marijuana, and for jeopardizing people’s lives in order to make opiate dealers like Phizer rich. You make him sound like a family man, but he left the FDA to go work at Phizer as a wealthy executive, selling powerful opiates which people often need kratom to get away from. Opiates are good, don’t stigmatize them either, but let’s be honest, this man served greedy pharmaceutical drug barons, not the American people.
    He approved more patented opiates but said we have to ban Kratom, a safe partial opiate agonist that does not cause respiratory arrest or addiction?
    Are we really going to accept this?
    Come on, let’s do better as a nation.

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