Farewell to Drug Regulations

Big Pharma Now Owns the FDA

Lots of people in the healthcare field heaved a sigh of relief last week when President Trump nominated Scott Gottlieb, a physician, venture investor and former official of the Food and Drug Administration, to be the FDA’s next commissioner. It comes as no surprise that Big Pharma is very, very happy.

Some healthcare experts were relieved that, whatever Gottlieb’s particular qualities, at least he wasn’t someone from the camp of “we-have-to-destroy-the-agency-to-save-it” species of Trump appointee like, say, Environmental Protection Agency boss Scott Pruitt.

Other expressions of relief came from investors and executives in the pharmaceutical industry. They see Gottlieb as one of their own, with good reason. He has served on advisory boards or held directorships at six drug manufacturing companies at least, and received substantial stipends from many more.

From 2013 through 2015 — the extent of a database maintained by the Department of Health and Human Services — Gottlieb received some $413,700 received from drug companies for consulting, speaking or other services. In 2015 alone, he collected $199,951 from eight drug companies, including GlaxoSmithKline, Squibb, Pfizer and Valeant. All are likely to have regulatory business with the FDA in coming years.

Gottlieb also is a venture partner at the investment firm New Enterprise Associates, which claims current investments in 50 biopharma firms, 29 medical device firms and 21 healthcare services firms.

So it shouldn’t come as a surprise that Big Pharma will be happy to have Gottlieb on board. “Thank God it’s Gottlieb,” investment analyst Brian Skorney of Robert W. Baird & Co. told clients in a research note quoted by Reuters. “We view this as a favorable development for the sector.”

Gottlieb is “entangled in an unprecedented web of Big Pharma ties,” Michael Carome, director of the Health Research Group at the advocacy organization Public Citizen said.

The most undistilled expression of Gottlieb’s philosophy can be found in a 2012 article he wrote for the conservative journal National Affairs. There he took aim at what he described as the FDA’s flawed culture in which the safety of a drug has become its prime concern. “In so heavily prioritizing one of its obligations — the protection of consumers — the FDA has sometimes… neglected its other key obligation, which is to guide new medical innovations to market,” he wrote. “On the whole, the agency’s reviewers believe it is appropriate to prioritize safety over speed.”

Big Pharma has been trying to get its wish list of deregulatory initiatives through Congress and the White House for years. With Gottlieb’s nomination, it may have landed in deregulation heaven.  What might the consequences be for your health and safety?