Trump's Hiring Freeze Will Help, Not Harm the FDA
In light of President Trump’s executive orders reducing federal regulations and freezing federal hiring, some worry that key federal agencies, such as the U.S. Food and Drug Administration (FDA), will lose their ability to function. They forget something: An FDA staffed to less than full capacity is a problem only if Trump intends the FDA to remain the leviathan agency it has become in recent decades.
But President Trump made it abundantly clear at a recent press conference that he has other plans for the agency. Regarding the FDA’s obstruction of last-chance efforts by terminally ill patients to save their lives with experimental drugs, Trump said: “We’re going to get the approvals much faster…So we’re going to be changing a lot of the rules.” One of the fastest ways to make drug approval easier is to reduce the FDA’s regulatory footprint.
All signs point to forthcoming FDA shrinkage, and so freezing hiring at this agency makes sense.
The first and most obvious reason is that the FDA is unlikely to accomplish anything earth-shattering until it has a new commissioner, appointed by the president and confirmed by the Senate. Former Commissioner Robert Califf, an Obama appointee, left his position at the end of Obama’s second term. Califf’s stand-in, Dr. Stephen Ostroff, who was formerly Deputy Commissioner for Foods and Veterinary Medicine, also joined FDA during the Obama years.
It may be reassuring to imagine that the FDA is like a racing yacht, needing all hands on deck. But, in reality, the FDA is more like a barge in port and blocking passersby. And it has been for years. Costly clinical trials requirements and extensive delays on drug approvals aren’t Trump’s fault; he just got there.
There are other reasons a temporary freeze on FDA hiring makes sense considering FDA’s impending shrinkage, and these are the candidates on Trump’s short list for FDA commissioner: Dr. Joseph Gulfo, Balaji Srinivasan, Jim O’Neill, and Dr. Scott Gottlieb.
All four candidates have voiced profound dissatisfaction with the FDA as we know it. Each is likely to reduce FDA’s regulatory footprint in the drug approval game, if given the chance. And they would probably do this not by accelerating the current approval processes — as does the bipartisan 21st Century Cures Act, signed by Obama — but, rather, by getting FDA out of the way.
Gulfo, the most recent flavor of the week, is a senior fellow at the Progressive Policy Institute and former CEO at the medical device developer Breakthrough Medical Innovations. He earned the nickname “the Antonin Scalia of the life sciences” from the Boston Business Journal due to his 2016 paper The Proper Role of the FDA for the 21st Century, published by the Mercatus Center at George Mason University. The abstract identifies the FDA as derailed by mission creep and charts a path home for FDA:
“The FDA’s mission is to permit safe and effective new drugs, biologics, and devices onto the market in an efficient and timely manner. But fear of being blamed for the failings of approved products has caused the FDA to become too restrictive. The FDA has strayed from the safety and effectiveness standards that are set out in the law…The FDA must return to its role as gatekeeper of safe and effective drugs and devices, and refrain from attempting to anticipate the future judgments of physicians and patients regarding benefits and risks.”
Gulfo’s insistence that the FDA snap back to its lawful scope of practice is redolent of the late Justice Scalia’s originalist approach to constitutional interpretation. Gulfo reportedly met twice with Trump’s transition team in January.
The other contenders seem to have even less love for the current FDA, and they have ideas for improving quality and lowering drug costs. For example, Srinivasan, who reportedly “hates the FDA,” has suggested that crowd-sourced review systems, such as Yelp, and crowd-sourced provider systems, such as Uber or Airbnb, could serve patients better than current FDA procedures. Srinivasan leads 21.co, a company developing technology for using the digital currency bitcoin.
O’Neill, a Silicon Valley investor, says the FDA should approve drugs based on evidence of their safety. As banal as this sounds, it goes against the conventional view that FDA approval should also be based on a drug’s proven effectiveness, as it is now . “We should reform FDA so there is approving drugs after their sponsors have demonstrated safety-at their own risk, but not much risk of safety,” O’Neill said in a 2014 speech at the Rejuvenation Biotechnology Conference. “Let’s prove efficacy after they’ve been legalized.”
The fourth contender is Gottlieb, a resident fellow at the American Enterprise Institute and former FDA deputy commissioner for medical and scientific affairs. According to Devon Herrick, a senior fellow at the National Center for Policy Analysis and author of the 2017 paper “How to Make New Drugs More Affordable,” Gottlieb has a “long history of advocating for changing the risk-averse culture at the agency and reducing its bureaucracy.”
Beyond these candidates for commissioner (and a few likeminded lieutenants), the FDA shouldn’t be hiring right now. In this new era of reduced regulation, there is one directive the agency can start following right away, even without a new commissioner: retreat.
Michael T. Hamilton (email@example.com) is a Heartland Institute research fellow and managing editor of Health Care News, author of the weekly Consumer Power Report, and host of the Health Care News Podcast. You can follow him on Twitter @MikeFreeMarket.