The vote was, as news reports say “largely” along party lines. But it was not as much so as some of the president’s other nominees, who had virtually no support from Senate Democrats. Five Democrats joined with the Senate’s 52 Republicans to confirm Gottlieb.
What will Scott Gottlieb as FDA commissioner mean for the clinical lab? Will approval of new diagnostics be accelerated or delayed? Will there be more stringent oversight of laboratory-developed tests (LDTs)?
To answer that, it’s useful to look at the new commissioner’s professional history. He is 44 years old, and he is a physician. (He is also a cancer survivor.) Unlike many of President Trump’s nominees for government posts, he is something of a “Washington insider”: He served in George W. Bush’s second administration as an FDA deputy commissioner, spent a year as a senior adviser to the administrator at the Centers for Medicare and Medicaid Services, and has been serving on the federal Health IT Policy Committee.
In the private sphere, he has been a fellow in the conservative American Enterprise Institute think tank. He has had success as a venture capitalist. He has had financial relationships with large pharmaceutical companies—a point that worried some senators who voted “no” on his confirmation. Reportedly, he has served on the boards of directors for American Pathology Partners, MedAvante, Glytec, Daiichi Sankyo, Aptiv Solutions, Gradalis, Tolero Pharmaceuticals, Molecular Insight Pharmaceuticals, and Bravo Health. Dr. Gottlieb promised senators that he would sever his ties to Big Pharma and the biotech industry, and divest himself from healthcare companies.
There is no question that as FDA head he will work toward creating a faster-track for drug approval, perhaps particularly for cancer drugs and “orphan” drugs for rare diseases. He wrote in 2012: “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. Ultimately, the only way to change the threshold for approval of these sorts of drugs is to change the FDA review culture itself.”
That tells you what he thinks and what he plans to do. He affirms that part of the FDA’s mission is to protect consumers. But he thinks that the other part is to help bring new products to the market, and he believes that has gotten short shrift, so he will restore the balance by making changes in the FDA review process. That is, the fast-track.
In the public mind, the FDA is mostly associated with drug approval. Of course, we know that it also approves medical devices and, most important I assume to the readers of MLO, diagnostics. So back to my original question: what does this mean for the clinical lab? Well, apart from the issue of companion diagnostics, it probably means that diagnostic assays will also be on a faster track, and that should be, in a broad sense, good for business. It may mean that the controversial topic of proposed tighter regulation of LDTs, which has been discussed in these pages and many other places for years now (e.g., my “From the Editor” in the January and March 2017 issues), will recede as the FDA backs further away from changing the status quo. That could be good for labs too—as long as sufficient (not duplicative) regulation remains in place to protect the public.
Everyone loses if that first “obligation” is lost. But if Dr. Gottlieb can thread the needle between public safety and industrial development, maybe everyone wins.