Scott Gottlieb wants to change "FDA review culture" to fast-track drug approvals
Critics says his ties to big pharma go back decades and are too complex to avoid
President Donald Trump’s pick to lead the Food and Drug Administration, Scott Gottlieb, is a physician, a cancer survivor, a venture capitalist and a government insider who has long said he wants to tear down the wall of FDA regulations he believes is holding back innovation.
“In so heavily prioritizing one of its obligations – the protection of consumers – the FDA has sometimes subordinated and neglected its other key obligation, which is to guide new medical innovations to market,” Gottlieb wrote in a 2012 issue of National Affairs. “Ultimately, the only way to change the threshold for approval of these sorts of drugs is to change the FDA review culture itself.”
The Pharmaceutical Research and Manufacturers of America, a trade and lobby association, sent out congratulations almost immediately after his nomination was announced in early March.
“We look forward to working with Dr. Gottlieb in his new role,” PhRMA President and CEO Stephen J. Ubl said, “as they seek to modernize the drug discovery and review process and advance competition in the biopharmaceutical market.”
But it’s his decades-long financial ties to many of those pharmaceutical companies that have critics worried.
“He currently is serving or has recently served on the boards of major pharmaceutical companies, including GlaxoSmithKline, one of the world’s largest,” said Dr. Michael Carome, director of Public Citizen, a consumer rights watchdog group. “And he has even more relationships that go back years.”
Carome points to Gottlieb’s recent financial disclosure letter to the Health and Human Services associate general counsel for ethics as evidence. In that letter, Gottlieb disclosed financial relationships with over 25 entities, many of them giants in the biotech and pharmaceutical industries.
“He’s basically been a shill for pharmaceutical corporations for much of his career,” Carome said, “and that has no doubt framed his thinking.”
“I’m not sure all of the sources of his income are measurable,” said Harvard government professor Daniel Carpenter, author of “Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA.” “That’s something we hope the Senate will look at during his confirmation hearing.”
Gottlieb will not be available to the media for comment until after his confirmation. But a White House representative told CNN that, despite criticism, the administration believes Gottlieb to be highly qualified, seeing him as a strong leader that will advance Trump’s agenda of reforming the drug industry.
A Washington insider
Gottlieb, 44, has a short history of public service. He was FDA deputy commissioner in the George W. Bush administration, did a yearlong stint as senior adviser to the administrator at the Centers for Medicare and Medicaid Services and currently serves on the federal Health IT Policy Committee.
Despite his inside-the-Beltline exposure, Gottlieb’s viewpoint on the FDA mirrors that of his potential boss: The agency needs an overhaul to reduce bureaucratic red tape and speed the drug pipeline.
In a January meeting with pharma executives, Trump laid out a plan to deeply cut the FDA’s regulatory playbook. “Instead of it being 9,000 pages, it’ll be 100 pages,” Trump told the group. “We’re also going to be streamlining the process so that from your standpoint, so that when you have a drug, you can actually get it approved – if it works – instead of waiting for many, many years.”
The choice of Gottlieb appears to have pleased many pharmaceutical executives, especially those companies whose stocks fell after Trump said they were “getting away with murder” with rising drug prices and an uncompetitive marketplace during his first news conference.
“Certainly, there’s been a loud chorus of support from pharma and medical device companies,” Carome observed. “They look forward to him being commissioner, as they believe he’ll promote their interests.”
Also pleased were organizations pushing for easing FDA regulations on unproven cancer treatments and so-called orphan drugs: medications that are not developed by a pharmaceutical company because the market is not large enough to make the drug profitable. Having won a fight against Hodgkin’s lymphoma, Gottlieb has been a strong advocate for modernizing the Critical Path Initiative, the development pathway drugs must take to market, and the recently passed 21st Century Cures Act, designed to speed development and approval of experimental treatments.
Friends of Cancer Research strongly supported Gottlieb’s nomination and urged Congress to “work quickly to confirm his appointment.”
The National Coalition for Cancer Survivorship followed suit in a statement applauding his nomination. “As a physician and cancer survivor, Dr. Gottlieb understands the human toll cancer takes on individuals and families, during both treatment and long-term survivorship,” Director Shelley Fuld Nasso said.
Even some industry watchdogs are cautiously optimistic. In a New England Journal of Medicine perspective, Rachel Sachs, a Washington University associate professor of law who studies the FDA, points to Gottlieb’s former ties to industry as potentially positive.
“As someone who understands the drug development process from all sides, he will be more informed,” said Sachs. “I’m going to wait to judge to see what policy decisions he comes to. Hopefully he has the agency’s best interest at heart.”
Can he be his own man?
For those worried about the President’s close relationship with vaccine opponents, such as Trump’s meeting with anti-vaxxer Robert Kennedy, Gottlieb’s views on vaccines will come as a relief. In a February 2015 CNBC interview, Gottlieb said the association between vaccines and autism has been “thoroughly debunked.”
He also took on his boss-to-be during last year’s campaign. In a column in Forbes, Gottlieb wrote that candidate Trump was tackling skyrocketing drug prices with an “aged” concept: importing medications from countries such as Canada that impose price controls.
“The Trump plan – while perhaps good politics – will offer consumers little relief,” Gottlieb wrote, pointing out that the prices American consumers pay for drugs was the lowest in five years.
But it’s not his backbone with Trump that has critics worried. It’s whether Gottlieb can adequately function in the role of the head of the FDA due to his history of financial ties to the pharmaceutical and biotech industries.
According to his biography, Gottlieb is or has been on the boards of directors for American Pathology Partners, MedAvante, Glytec, Daiichi Sankyo, Aptiv Solutions, Gradalis, Tolero Pharmaceuticals, Molecular Insight Pharmaceuticals and Bravo Health. He was an independent advisor to Vertex Pharmaceuticals.
“Corporate board memberships are incredibly lucrative,” said Harvard’s Carpenter, who also wrote a perspective on Gottlieb for the New England Journal of Medicine. “Studies show an average of $250,000 to $300,000 a year per corporation. It’s a huge source of conflicts of interest.”
Since 2007, Gottlieb has been a venture partner at New Enterprise Associates, which has an enormous portfolio of health care investments. Gottlieb is also a seven-year member of GlaxoSmithKline’s Product Investment Board and for the past four years has been managing director for T.R. Winston, a private merchant bank that invests in health care and high-growth sectors.
In his ethics disclosure, Gottlieb says he has no financial interest in New Enterprise or T.R. Winston but does have financial ties to 19 of their client companies, which make products or drugs for kidney disease, diabetes, pathology, radiology, cancer and muscular dystrophy, to name just a few.
“What we know for sure about Gottlieb’s income is that from 2013 to 2015, he was paid about $413,000 by various pharmaceutical and medical device companies,” Carpenter said, referencing data from ProPublica’s Dollars for Doctors database, which is extracted from the CMS Open Payments website.
Citing financial disclosure documents filed with government ethics officials, the Wall Street Journal reported that Gottlieb made much more in just one year, approximately $3 million in speaking, consulting and retainer fees from January 2016 through March 1, 2017.
While the former FDA commissioner, Dr. Robert Califf, was also criticized for his ties to industry, Carpenter said the money Califf received is dwarfed by that paid to Gottlieb.
“From 2013-2015, Califf had about $60,000 in payments from pharmaceutical companies, about the same as a university professor would get from National Institute of Health grants,” Carpenter said. “And Califf had ties to industry in part because he was sought after due to his innovative clinical trial expertise – he was a pioneer in the field. Gottlieb has political connections at the FDA.
“There is a huge difference between research work with these companies and being a consultant sitting on a board,” Carpenter added. “There, you are making decisions about corporate management; you’re not doing the science.”
’Is recusal sufficient?’
Gottlieb’s letter to the Health and Human Services ethics counsel says he plans to resign within 90 days of his confirmation from any board or other positions he currently holds, divest himself of stock and then recuse himself for one year from any FDA decisions that may involve or impact those companies, unless given a waiver in advance.
Government ethics laws require employees to disqualify themselves for a period of time from duties related to former employers, including consulting relationships.
“Is recusal really sufficient?” asked Public Citizen’s Carome. “We believe it’s not. It’s really impossible to disentangle himself from these conflicts. He is really not qualified and in fact should be disqualified because of these ties.”
Both Carome and Carpenter point to what happened during Gottlieb’s 2005-07 stint as the FDA’s deputy commissioner for medical and scientific affairs.
An August 2005 memo (PDF) shows that while he was deputy FDA commissioner, Gottlieb had to recuse himself from any deliberations or decisions regarding nine major pharma and consumer health companies, including Roche, Sanofi-Aventis, Serono, Eli Lilly, VaxGen and Inamed.
Around the time of his recusal, Inamed was petitioning the FDA for reapproval of its controversial silicone breast implants, VaxGen was still trying to develop an anthrax vaccine despite withdrawing its AIDS vaccines after faulty test results were uncovered, and Eli Lilly was facing charges that it was illegally marketing its antipsychotic drug Zyprexa and hiding serious side effects.
Fast-forward to today, and you find the agency facing similar decisions about companies Gottlieb has worked with for years. Just last week, one of GlaxoSmithKline’s best-selling products, the inhaler Advair Diskus, won a temporary victory when the FDA rejected a competitor’s bid to sell a generic version. A decision on another competitor is due soon. Although Gottlieb is on the record for fast-tracking generics, he’s also been on GSK’s payroll for years.
“The worry here is that you’re damned if you do and damned if you don’t,” Carpenter said. “If he’s constantly recusing himself, he can’t function as commissioner, because he’s taking himself out of play for a wide variety of decisions. But if he doesn’t, then we should worry even more about conflicts of interest.”
Join the conversation
Washington University’s Sachs puts aside her cautious optimism on this count.
“With Gottlieb, conflicts of interest should be of concern and should be addressed,” she said. “He may be able to recuse himself from particular decisions, but he will be called on to make policy decisions that will affect the entire industry. So of course it concerns me.”
For Carpenter, the issue goes beyond cronyism. He sees Gottlieb’s nomination as an attack by the Trump administration on the FDA and its credibility.
“What the FDA does is more than guarantee the safety and effectiveness of our medicine, it also guarantees that we can trust that medicine and that it will work as advertised,” Carpenter said. “Absent that trust, insurers would bail; patients wouldn’t trust drugs or their doctors.
“I’m concerned that the scientific bases of drug testing and review is going to be undermined, whether by Gottlieb or by other things the Trump administration does,” he continued, “and sooner or later, it’s going to affect the credibility of our medicine cabinet.”