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.