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Our Take: Gottlieb out as FDA chief

Mar 11, 2019

Department of Health and Human Services (HHS) Secretary Alex Azar confirmed Tuesday that FDA Commissioner Scott Gottlieb has resigned, effective in about a month. Dr. Gottlieb said he wanted to spend more time with his wife and three daughters, after making the weekly commute from Washington D.C. to Connecticut over the last three years.

“All of us at HHS are proud of the remarkable work Commissioner Gottlieb has done at the FDA,” HHS Secretary Alex Azar said. “He has been an exemplary public health leader, aggressive advocate for American patients and passionate promoter of innovation. The public health of our country is better off for the work Scott and the entire FDA team have done over the last two years.”

Our TakeNo one saw this coming. And despite the “spend more time with family” reason for leaving—Washington-speak for “I’m leaving for a different reason”—our sources say that it’s true.

The Washington Post reported that the move was particularly surprising, given that he had recently hired new staff members and was aggressively pushing policy initiatives, including measures to quell the opioid crisis and eliminate the rebate system for prescription drugs.

The 46-year-old physician, venture capitalist, philanthropist, and cancer survivor was unlike any of his predecessors in recent memory. While some viewed him with skepticism upon taking the job, considering industry ties and investments, Gottlieb quickly began making a name for himself, issuing lengthly press releases detailing agency initiatives.

Gottlieb also became a prolific user of social media, at least by FDA commissioner standards.

Gottlieb will be most remembered for his successful drive to expedite generic drug approvals in an effort to reduce health care costs. In Fiscal Year 2018, the FDA approved a record total of 781 generic drugs during its 2018 fiscal year, up from the previous record of 763 set in 2018.

He also fought the e-cigarette industry, helping to ban the sale of flavored e-cigarettes in convenience store outlets.

We saw Gottlieb as a competent bureaucrat—and we mean that in the most complimentary way—similar to the job that Seema Verma has done as CMS Administrator and Alex Azar has as HHS Secretary. Most of the time they keep their heads down, focused on moving initiatives forward and staying away from politics (as much as one can expect).

Gottlieb set the bar high for his predecessor. He will be missed.

What else you need to know
The cost of treatment is up to 22 times higher at a freestanding emergency department (FSED) than at a physician’s office, an analysis by UnitedHealth Group shows. According to the report, just 2.3 percent of visits to FSEDs in the U.S. are emergent and require services available only at an ED. In Texas, which has nearly half of the country’s FSEDs, the average cost of treatment at an FSED for a set of 10 common nonemergent conditions, such as fever and sore throat, is $3,217, versus $146 at a physician’s office and $167 at an urgent care center.

CMS is looking for ways to make it easier for consumers to buy health insurance in a state other than where they live. The agency issued a request for information (RFI) last Wednesday seeking recommendations “on how to eliminate regulatory, operational and financial barriers to enhance issuers’ ability to sell health insurance coverage across state lines.” The RFI, which stems from an executive order issued in October 2017, is open for public comment for 60 days.

Home dialysis providers could benefit greatly if CMS takes steps to revamp kidney care in the U.S. Speaking at the sixth annual Kidney Patient Summit last Monday, HHS Secretary Azar said kidney care has “some of the worst incentives in health care,” noting that “it’s the epitome of a system that pays for sickness rather than health.” CMS Administrator Seema Verma told Reuters that the agency is considering a trial payment model that would improve care for patients with early-stage kidney disease, increase access to kidney transplants and provide incentives for the use of home dialysis rather than clinic-based treatments. More here.

From his prison cell, Martin Shkreli, the fallen former CEO of Turing Pharmaceuticals who raised the price of the antiparasitic Daraprim (pyrimethamine) by 5,000 percent, is still steering the company, now named Phoenixus AG, according to a report on Thursday by The Wall Street Journal. He is serving a seven-year sentence after being convicted in 2017 of securities fraud and conspiracy while he was CEO of biotech firm Retrophin. The Journal reported that Shkreli has a 40 percent stake in Phoenixus, which, when combined with votes from other shareholders who are loyal to him, gives him enough power to call the shots. The Bureau of Prisons is investigating the matter, USA Today reported Friday. More here (requires a subscription).

At long last, the Amazon-Berkshire Hathaway-JPMorgan health care venture has a name: Haven. The nonprofit entity, created in January 2018 and headquartered in Boston (with an office in New York), initially will focus on lowering health care costs for the 1.2 million U.S. employees and families affiliated with the three founding companies. Dr. Atul Gawande, Haven’s CEO, said in a press release that the plan is to “start small, learn from the experience of patients and continue to expand to meet their needs.” Along with the new name, there’s also a new website.

Product news
Janssen Pharmaceuticals received FDA approval for Spravat (eskatamine), the first new treatment mechanism for major depressive disorder in decades. It’s approved for use in combination with oral antidepressants in patients who have treatment-resistant depression. Spravato is a form of ketamine, which is sold illegally as a street drug, and will be launched under a Risk Evaluation and Mitigation Strategy, with a boxed warning in the labeling. It will be administered only in certified doctor’s offices or clinics, and patients must be monitored for at least two hours before being released. The list price for Spravato will be as high as $6,785 for the first month of treatment and between $2,360 and $3,450 per month thereafter, FiercePharma reported.

Eli Lillannounced last Monday that it will launch an authorized generic version of its Humalog (insulin lispro) for patients with diabetes. With a list price of $137.35 per vial or $265.20 for a package of five KwikPens, the generic version will cost half as much as the brand-name product. Lilly, Sanofi and Novo Nordisk are all under scrutiny for price hikes on their insulin products.

Genentech’s Tecentriq (atezolizumab) is the first immunotherapy to gain FDA approval for breast cancer. It received accelerated approved on Friday for use in combination with Celgene’s Abraxane (nab-paclitaxel) as a first-line treatment for unresectable locally advanced or metastatic, PD-L1-positive triple-negative breast cancer. Tecentriq is also approved for use in treating advanced kidney cancer and metastatic non-small cell lung cancer.

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