Westporter Moves One Step Closer To FDA Helm

As with so many things in Washington these days, today’s Senate committee hearing on the nomination of Westporter Scott Gottlieb as head of the Food and Drug Administration was either a spectacular success — or another stumble.

It all depends on whose news you believe.

NBC’s report — posted at 11:56 a.m. — was headlined “Opponents of FDA Nominee Scott Gottlieb Invoke Opioid Crisis.” High up in the story was this:

Gottlieb is a Washington fixture, with a medical degree, experience at the FDA and in the Centers for Medicare and Medicaid Services. He is a fellow at the right-leaning American Enterprise Institute and a respected health policy analyst.

But his critics cite his ties to the drug industry and his role at New Enterprise Associates, which bills itself as the world’s largest venture capital firm. It invests heavily in medical technology and healthcare companies.

They seized on the opioid crisis as Gottlieb’s potential weak spot.

“Trump’s nominee to be the next FDA commissioner, Dr. Gottlieb, is entangled in an unprecedented web of close financial and business ties to the pharmaceutical industry and was no doubt chosen because he is well-suited to carry out the president’s reckless, ill-informed vision for deregulating the FDA’s review and approval process for prescription medications, including opioids,” Dr. Michael Carome, director of Public Citizen’s Health Research Group, told reporters on a conference call.

“Dr. Gottlieb has had a cozy relationship with big drug companies for decades,” added Sherrod Brown, a Democratic senator from Ohio. “He has supported allowing those same companies to rush their drugs — including potentially addictive opioid painkillers — onto the market before we’re sure that they’re safe,” Brown added.

At 2:55 p.m., MarketWatch announced: “Scott Gottlieb sailed through his FDA commissioner hearing.” Its reprint of a Wall Street Journal story said:

Scott Gottlieb, President Donald Trump’s nominee to run the Food and Drug Administration, emphasized in his confirmation hearing Wednesday his belief “in the gold standard of safety and efficacy” at the agency and said he hopes to expand approvals of generic drugs to lower U.S. prices.

Dr. Gottlieb, who was nominated in March, said he sees the need for new laws and FDA regulatory action to get complex-formulation drugs—like those used topically or with inhalers—more quickly approved as lower-cost generics. While he also said there are ways to speed up some clinical trials, “I think there are ways to modernize clinical studies without sacrificing the gold standard.”

His comments appeared aimed at reassuring Democrats, who have been critical of the nomination because of Dr. Gottlieb’s extensive financial ties to drug makers and his prolific, often conservative writings in which he has been critical FDA regulation, often saying the agency should move faster.

The tension between speed and a focus on safety has been at the center of political debates over the FDA’s future. That has especially been the case under the Trump Administration, since the president has said the FDA takes too long in approving drugs and medical devices.

In addition to his work as a resident fellow at the American Enterprise Institute, Gottlieb is a clinical assistant professor at New York University School of Medicine, and an internist at Tisch Hospital.

Republican Senators Orrin Hatch and Lamar Alexander lavishly praised Gottlieb. A Hodgkin’s lymphoma survivor, he also has the support of groups like the National Comprehensive Cancer Network, which he serves as an adviser.

A vote on Gottlieb’s nomination is expected later this month. If confirmed, he will be the 2nd-highest-ranking Westporter in Washington — or 1st, now that FBI director James Comey’s house is on the market. is the highest-ranking Westport in Washington, now that James Comey has left town.

(Hat tip: Luke Hammerman)