FDA Watch: Gottlieb Resignation Costs Lab Industry a Valuable Frenemy

Scott Gottlieb, M.D., is resigning as FDA commissioner, the position he’s held since 2017. Although his reign lasted just two years, Gottlieb has been a longtime friend and foe of the lab industry having served as deputy commissioner during the George W. Bush administration. The key question: Will the initiatives and policies he championed during his tenure continue after he’s gone?

Why Gottlieb Is Leaving
The first clue to answering that question is that Gottlieb isn’t being forced out. He’s resigning for personal rather than political reasons, namely his desire to be closer to his wife and three young daughters in Westport, CT.

His Legacy & Impact on Labs
Gottlieb will be remembered for his commitment to making one of the federal government’s most opaque agencies more transparent and his energy in advocating reforms designed to simplify and speed up the cumbersome FDA approval process and ending the “shenanigans” that thwart competition.

Historically, becoming FDA commissioner has proven a less than effective way of winning friends in the lab industry. But Gottlieb was different. What the industry really appreciated (and may sorely miss when he’s gone) was Gottlieb’s willingness to tackle the controversial lab-developed tests (LDTs) issue. “The agency helped support major legislative efforts to secure a more modern framework for the efficient regulation of diagnostic tests,” Gottlieb said in his resignation letter.

Under Gottlieb, the agency has made several proposals to make it easier to bring new tests to market. Specifically, it has worked with industry and Congress to generate support for the VALID Act, a bill aimed at resolving the longstanding controversy around FDA regulation of LDTs that would bring all diagnostics under a single regulatory pathway using more modern and technologically realistic approval criteria.

Meanwhile, the volume of test approvals has increased markedly during Gottlieb’s tenure, including:

• Two new flu tests;
• First NGS residual cancer detection test to gain FDA approval;
• New point-of-care tests for Ebola; and
• First approved objective blood test for concussion evaluation.

Under Gottlieb, the FDA also softened its previous resistance to genetic tests, most notably in allowing 23andMe to engage in direct to consumer marketing of its products. So, it’s not that biotechnology stocks fell on the day he announced his resignation.

Of course, lab tests are just part of the story. Gottlieb has also won praise for his determination to speed approval of new generic drugs and the agency’s handling of the opioid crisis. Of course, he’s not without critics. One problem area is his support for e-cigarettes, which the anti-tobacco groups contend has contributed to the growth of vaping among teens. Gottlieb has also managed to tick off the other side by pushing to regulate the amount of nicotine in cigarettes and proposing a ban on menthol cigarettes.

His Successor
Norman Sharpless, M.D., director of the National Cancer Institute has been named acting commissioner. He will oversee the agency until President Trump nominates and the Senate confirms a permanent successor.

New FDA Approvals
Here’s a look at the key FDA approvals announced from late February to late March:

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New CE Marks & Global Certifications
Notable European CE certifications during the period:

Other international clearances announced during the period: