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Scott Gottlieb, the new FDA chief, explained

Trump wants to deregulate the Food and Drug Administration. He chose the right guy for the job.

Nomination Hearing Held For Scott Gottlieb To Head The FDA Department
Scott Gottlieb at his senate confirmation hearing in April.
Photo by Zach Gibson/Getty Images

Scott Gottlieb, President Trump’s choice for head of the Food and Drug Administration, was confirmed by the Senate on Tuesday in a 57 to 42 vote.

The former deputy commissioner of the FDA under George W. Bush will come to the job with strong views about what FDA reform might look like — unlike many of Trump’s other nominees.

He was also the most mainstream of Trump’s rumored FDA choices. Others included Silicon Valley insiders like Jim O’Neill and Balaji Srinivasan, who both have no background in medicine and seemingly little appreciation for how medical regulation works.

At Gottlieb’s senate confirmation hearing last month he promised science would prevail at the agency, according to AP, and he vigorously defended vaccines. “This has been one of the most exhaustively studied questions in history," he said. There “is no causal link between vaccination and autism.”

That an FDA commissioner would even be asked this question speaks to what a bizarre moment in history this is. But with this unequivocal statement about vaccine safety, Gottlieb set himself apart from the President, who has suggested vaccines may be harming people and causing autism, and from the seething populist movement that seems intent on undermining science and public health.

Still, he doesn’t come without controversy: Critics have pointed out that his web of ties to pharmaceutical companies may have compromised his ability to steer the FDA. Here’s what we might expect with Gottlieb taking the helm at FDA.

Gottlieb wants to speed up generic approvals to bring down the cost of drugs

One of Trump’s few talking points about medicine has to do with the cost of drugs. He has been aggressive about singling out pharmaceutical companies for “getting away with murder” with their “astronomical” prices.

One way to do this would be to bring cheaper generic drugs to market — and Gottlieb has been championing that idea for years, according to Bloomberg.

After a drug gets FDA approval, its manufacturer enjoys a period of monopoly through patent protection — which means it’s the only company allowed to make that drug, and so can generally demand higher prices. Once that exclusivity period is over, generic drugmakers can enter the market, offering low-cost copycats.

These medicines are drastically cheaper than their brand-name counterparts, mainly because generic drugmakers piggyback on all the research and development that was done by the original drugmaker. This means generic manufacturers don't bear the same R&D costs. They also don't spend much on marketing — a massive cost for pharma.

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 brand-name alternatives — such as various types of hepatitis C treatments or even different insulin therapies — come onto the market, drug prices don’t drop dramatically. When competition from interchangeable generic products increases, they do.

As FDA head, Gottlieb may try to improve competition among cheaper generic products, which would help bring down drug costs. Here’s Bloomberg again:

At a March 6 speech during a conference in Orlando, Florida, Gottlieb also talked about overhauling the rules for complex generic drugs with which brand-name companies have been able to create “monopolies in perpetuity.” He also discussed the need to inject competition in situations where decades-old drugs are provided by one generic supplier, allowing speculators to buy the drug and jack up the price.

Gottlieb favors faster drug approvals

Trump has vowed to cut 75 to 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 the FDA’s guidance and rules.

One of the key notions underpinning Trump’s view of the FDA is that if the agency just got rid of some of the pesky restrictions for drug approval, we could have a golden age in drug development.

Gottlieb also has a track record of favoring faster drug approvals. In a 2012 article in National Affairs, he discussed how the agency’s “hunger for extreme certainty about how drugs work” had become too burdensome, and put up many hurdles for the FDA approving a drug for a rare disease called Hunter syndrome:

In an effort to satisfy an increasingly unreasonable hunger for statistical certainty on the part of the FDA, the trial imposed extraordinary hardships on the children and families involved. In order to approve the drug for use, the FDA required the trial to involve 96 patients with Hunter syndrome — some 20% of all Americans afflicted with the disease. Moreover, for the first time in such a study of enzyme-replacement therapy, the FDA also insisted that patients be randomly assigned to receive either the experimental drug or an inert placebo.

Trump and Gottlieb are not alone in their views. There’s been a push to drive down the evidentiary standards at the FDA by allowing lower-quality evidence to be weighted in drug approval decisions. The argument is that this would help bring new drugs onto the market more quickly, and help spur innovation.

But many independent researchers and public interest groups point out that the FDA is already the fastest regulatory agency in the world, particularly with the advent of expedited regulatory pathways for rare, serious, or life-threatening diseases.

The reason we don’t have more medical breakthroughs coming to the market, those researchers argue, isn’t because the FDA is too sluggish; it’s because discovering them is really, really hard. There’s mixed evidence on whether speedier review times have led to more drug innovation.

For what it’s worth, Gottlieb has said FDA needs to strake a balance among speed, good science, and safety. "We should reject a false dichotomy that it all boils down to a choice between speed and safety," he said in April.

Gottlieb would like to give more power to doctors to make decisions about drugs

In that National Affairs piece, Gottlieb also 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.” The implication here is that the agency has become too paternalistic, and that doctors should have more discretion over the safety of drugs available and whether they would be helpful to patients.

Recent history suggests that undoing some of that regulation to put more power in the hands of doctors might not be a great move for patients.

The reason we have all these FDA scientists vetting data on drugs to make sure they are safe and effective is because it’s really hard for doctors to do that job by themselves.

The agency starting asking drug companies to prove their products were both safe and effective before they hit the market in 1962, after the infamous scandal around thalidomide, a morning sickness medication that caused severe birth defects. An FDA medical officer, Dr. Frances Kelsey, adamantly opposed allowing thalidomide to be sold in the US — saving American families from the pain wrought by the drug in many other countries.

Not only would it be extremely time-consuming to expect doctors to review clinical trials themselves, but it might also compromise patient safety, since the results of many clinical trials never see the light of day. (FDA reviewers have access to unpublished patient-level data that doctors don’t — and it’s their job vet it.)

Even still, there’s been a push by conservative and libertarian think tanks, such as the American Enterprise Institute (where Gottlieb has been a fellow) to roll back weighty regulations and give more power to doctors and patients.

Gottlieb has some serious conflicts of interest

One of the major sticking points around Gottlieb’s confirmation was what Sen. Patty Murray (D-WA) called his “unprecedented financial entanglements” with the pharmaceutical industry.

Gottlieb 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.

“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’s also partner at a large venture capital firm, New Enterprise Associates, a senior principal at the investment bank TR Winston, and partner at the hedge fund Arcoda Capital Management — all health care–centric finance groups.

Days before the hearing, Endpoints News reported, “he carefully delineated ties to some two dozen biopharma companies he’s been working with over the past eight years of the Obama administration.” He also said he’d be an “impartial and independent advocate for the public health.”

But that may not be easy, Daniel Carpenter, a Harvard professor who wrote a history of the FDA, told Vox. “These are not relationships whose influence just disappears once he resigns from a corporate board.” He added: “He would be the most interest-conflicted commissioner in American history, by far.”

When compared with Trump’s other picks, though, Gottlieb — with his medical background and extensive FDA experience — seems like a prudent choice, which may have been the reason the administration threw out those other names. “It could have been worse,” said Gregg Gonsalves, a Yale research scholar. “We could have had a saber-toothed tiger guarding the henhouse like Jim O’Neill, and instead we [get] a garden-variety fox at the helm.”

One thing is certain, Gonsalves added: “Unlike many Trump nominees, he's actually highly qualified to destroy the agency he's meant to lead.”

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