Scott Gottlieb, a former deputy commissioner of the Food and Drug Administration, has deep ties with pharmaceutical companies that may jeopardise his ability to steer the FDA independently.
He wants the agency to approve drugs more quickly, particularly generic drugs. Gottlieb is a doctor and pharmaceutical industry darling, but is more mainstream than the other rumoured potential candidates, such as Silicon Valley insiders like Jim O’Neill and Balaji Srinivasan, who have background in medicine and seemingly little appreciation for how medical regulation works.
Five facts about Gottlieb:
- He’s a Hodgkin lymphoma cancer survivor
- He is a big proponent of vaccines
- He graduated in 1994 from Wesleyan University
- He got his medical degree in 1999 from the Mount Sinai School of Medicine in New York
- He’s done two stints at the FDA, from 2003 to 2004, and again in 2005 as deputy commissioner.
- He’s a fellow at the conservative think tank the American Enterprise Institute
When compared with other picks by Trump, Gottlieb seems like a prudent choice, given his qualified background. But one thing is certain, unlike other nominees; he is also highly qualified to destroy the agency he is meant to lead.
Brand-name vs generic drugmakers
In his rare moments of elaboration into healthcare reform, one of President Trump’s few talking points is the sky-high cost of drugs. He has said that pharmaceutical companies are “getting away with murder” with their “astronomical” prices.
Gottlieb believes the way to bring down these costs is to speed up the approvals process of generic drugs to the market – an idea that he has been championing for years.
Currently, when a drug succeeds in getting FDA approval the manufacturer of the drug enjoys a period of monopoly due to patent protection, meaning they are the only company allowed make the drug and can therefore demand higher prices. Once that exclusivity period is over, other drugmakers can enter the market and offer low cost copycats.
Generic drugmakers piggyback on all the research and development done by the original manufacturer and also do not spend much on marketing, making their medicines drastically cheaper. For instance, six tablets of the brand-name antibiotic Zithromax cost $150 — while the same amount of the generic version, azithromycin, costs about $10.
When other brand name drugmakers enter the market to compete with the original manufacturers, the prices doesn’t drop, but when interchangeable generic products become available, the price does drop.
Gottlieb is expected to improve competition between generic and brand name producers in order to bring down costs. He has talked about overhauling the rules that have effectively allowed brand-name companies to create monopolies in perpetuity.
Faster drug approvals
Trump has vowed to cut 75-80 percent of government regulations. “Instead of it being 9,000 pages, it’ll be 100 pages,” he told a group of pharmaceutical company executives in January, presumably in reference to FDA’s guidance and rules.
Trump believes that if the FDA were just able to get rid of some of those pesky restrictions for drug approval then there could be a golden age of drug development, this is a view shared by Gottlieb and backed up by his track record. He has discussed that the FDA’s “hunger for extreme certainty about how drugs work” has hindered progress, stopping approval for lifesaving drugs.
They want to drive down evidentiary standards by allowing lower-quality evidence to be weighted in drug approval decisions, arguing that this would bring new drugs to the market more quickly and help drive innovation.
Currently, the FDA is already the fastest regulatory agency in the world, particularly when it comes to pathways for rare or life-threatening diseases. Critics argue that more breakthroughs aren’t coming to the market not because the FDA is too sluggish, but because discovering them in the first place is extremely difficult.
Doctors to make more decisions
In a National Affairs piece, Gottlieb wrote, “The modern FDA is driven by a profound lack of confidence in the ability of doctors to make careful judgments. The agency regulates drug makers, but it does not regulate doctors.”
Gottlieb is implying here that the FDA has too much oversight and more trust and discretion should be left in doctors’ hands. However, recent history suggests that undoing some of this regulation to put more power in the hands of doctors might not be beneficial to patients.
This is because FDA scientists vetting the data on drugs are employed to do just that, whereas doctors have more on their plate already, and find that job hard to do by themselves. Not only is there the time-consuming element to reviewing clinical trials, but FDA reviews have access to unpublished patient-level data that doctors do not.
Nevertheless, there’s been a push by think tanks such as the American Enterprise Institute (where Gottlieb has been a fellow) to roll back these regulations and give more power to doctors and patients.
Conflicts of interest
Gottlieb still needs to be confirmed by the Senate, and one of the stumbling blocks they will face is his conflicts of interest.
According to the public interest group Public Citizen, “Gottlieb is entangled in an unprecedented web of Big Pharma ties.” He currently serves or has served on five pharmaceutical companies’ boards, including GlaxoSmithKline, and was recused from meetings and decisions while serving as FDA deputy commissioner because of these conflicts.
Trump nominating GlaxoSmithKline’s Scott Gottlieb to lead the FDA is all you need to know about his fake claims re taking on big pharma.
— Lee Fang (@lhfang) March 10, 2017
“Between 2013 and 2015, Gottlieb received a total of at least $413,000 from multiple pharma and medical device companies, most for consulting and speaking fees,” Public Citizen reported.
He is also a partner at New Enterprise Associates, a large venture capital firm, along with being a senior principal at the investment bank TR Winston, and partner at the hedge fund Arcoda Capital Management — all health care–centric finance groups.
To be approved he would need to resign from the pharmaceutical boards, get rid of shares held in companies that he would end up regulating at the FDA, but a severance of these ties is not so easy. Daniel Carpenter, a Harvard professor who wrote a history of the FDA said, “These are not relationships whose influence just disappears once he resigns from a corporate board.” He added: “If [Gottlieb] is confirmed, he would be the most interest-conflicted commissioner in American history, by far.”