Trump’s FDA Commissioner Could Spur a Revolt

[Analysis by Jim Dickinson] While the Obama administration’s defense of FDA was, fundamentally, as feeble as its latter-day predecessors, the FDA-relevant signs from the incoming Trump Administration are that the very idea of FDA defense could be out the window. The agency’s bedrock premise – proof of product safety and efficacy, enshrined in statutes – seems is now open to revision, even repeal and replacement. And that could bring internal FDA revolt.

The same disenfranchised – and basically uninformed -- minorities that propelled Trump into office will likely support the new regime’s efforts to repeal and replace FDA’s regulatory authority to control not only everything about new drugs’ market entry but the market entry of new medical devices and other health-related products.

It’s hard to remember the tragedies that propelled the safety and efficacy statutes that today form FDA’s raison d’être, but they deserve a revisit now: hundreds of deaths from sham products (elixir of sulfanilamide) in the 1930s and from mutagenic products (thalidomide) in the late 1950s. To suggest – as one of Trump’s reported candidates for FDA commissioner does – the repeal of the statutory efficacy requirement is to attack the basis of FDA’s mission since 1962.

So what? To quote the classic mantra of the history scorners: “That was then ꟷ this is now.” But now has always had its roots, and thus its destiny, in then. As philosophers and statesmen have warned for hundreds of years, those who don’t know history are doomed to repeat it, and that surely goes for FDA’s implementation of its 55-year-old statutory efficacy requirement.

A significant online body of resistance to Trump’s known FDA commissioner candidates is developing, suggesting a grueling confirmation process if any of them is ultimately nominated. As previously reported, they are venture capitalists Balaji Srinivasan and Jim O’Neil, and former FDA deputy commissioner Scott Gottleib. Online comments against the candidates cite their public writings and statements showing, variously, divergence from the agency’s mission, hostility to the efficacy standard and the agency’s notorious bureaucratic slowness in processing applications and petitions, as well as in responding to issues in public controversies.

These critics, joined by others they energize in cyber space, would surely make their strong opposition widely known, both directly and through their U.S. senators and the media, during the confirmation process if they are nominated.

Should either Srinivasan or O’Neil ꟷ and to a lesser extent, Gottleib who at least is an MD ꟷ survive confirmation and become the next commissioner, any directives by or through them to reduce scientific standards and especially to undermine the efficacy requirement would meet strong resistance or even revolt within the agency. FDA’s medical professionals, most of whom have turned away from more lucrative careers in the private sector, share a rarely expressed but deep dedication to the agency’s mission. They comprise 32% (5,179) of the 16,075-person FDA workforce and through their professional associations and union membership can be expected to make a lot of trouble over improper politically motivated directives.

That trouble could take different forms, including voluntary “work to regulations” slow-downs in processing documents, complaints to “watchdog” activist groups that can generate lawsuits and headlines, complaints to elected representatives, picketing of FDA buildings and organized demonstrations.

Ideology can push science only so far, until resistance becomes blockage.