At least four names remain on President Donald Trump’s short list of candidates to head the U.S. Food and Drug Administration (FDA).
Dr. Joseph Gulfo, a senior fellow at the Progressive Policy Institute and former CEO of the medical device developer Breakthrough Medical Innovations, has spoken twice with members of Trump’s transition team about possibly filling the vacant FDA commissioner position, STAT News reported on January 23, 2017.
Other contenders are Jim O’Neill, a Silicon Valley investor and libertarian, and Balaji Srinivasan, CEO of 21.co, a company developing technology for using the digital currency bitcoin.
White House Press Secretary Sean Spicer told reporters O’Neill and Srinivasan “are being considered for positions in the FDA,” CNBC reported on January 12.
Dr. Scott Gottlieb, a resident fellow at the American Enterprise Institute and former FDA deputy commissioner for medical and scientific affairs, is also under consideration.
FDA Overhaul Possible
Gulfo coauthored The Proper Role of the FDA for the 21st Century, a paper published by the Mercatus Center at George Mason University in 2016 arguing FDA’s current drug approval process oversteps the agency’s lawful scope.
“The FDA has strayed from the safety and effectiveness standards that are set out in the law, instead applying standards for approval based on predicting the benefits and risks … an ‘average patient’ will experience,” the Mercatus paper states. “[These] outcomes are better evaluated in real-world, post-market settings, that is, in the medical marketplace, where knowledge about the value of a drug or device for different types of patients can grow over time.”
O’Neill says FDA should approve drugs based on evidence of their safety instead of effectiveness. In a 2014 speech at the Rejuvenation Biotechnology Conference, O’Neill said, “We should reform FDA so there’s approving drugs after their sponsors have demonstrated safety at their own risk—not much risk of safety, but let’s prove efficacy after they’ve been legalized.”
All-Star Candidates?
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,” says Trump’s list is short but strong.
“All the candidates for the job are highly accomplished, intelligent people,” Herrick told Health Care News. “Trump’s pick to head the FDA is an important one.”
Gottlieb and Gulfo understand risk assessment is a value judgment best left to patients, providers, and drug developers, Herrick says.
“Dr. Scott Gottlieb has experience working as the FDA deputy commissioner,” Herrick said. “He has a long history of advocating for changing the risk-averse culture at the agency and reducing its bureaucracy. Dr. Gulfo also has a firm understanding of how a risk-averse agency can slow drug development to a crawl, by erring on the side of caution rather than taking bold risks.”
Filling the ‘Liberty Gap’
Dr. John Hunt, a pediatrician, pulmonologist, and policy advisor to The Heartland Institute, which publishes Health Care News, says O’Neill’s background as a Washington, DC-outsider would make him an objective commissioner.
“My guess is that O’Neill would have no problem recognizing that FDA is extra-constitutional and that he won’t get stuck in trying to fix minutiae when the whole foundation is the failing,” Hunt said. “Time in a position of government doesn’t make one wise, but it does tend to infect one’s brain with collectivism and narcissism. O’Neill doesn’t seem to have been exposed to the contagion.”
The next FDA commissioner’s grasp of liberty will prove more important than his understanding of particular drugs and medical devices, Hunt says.
“There will be plenty of FDA and drug and device experts available to fill O’Neill’s knowledge gap,” Hunt said. “What we need in government is O’Neill’s ability to fill government’s liberty gap.”
Rebalancing Responsibility
Hunt says removing FDA’s requirement to demonstrate a drug’s efficacy would give developers a greater incentive to ensure their drugs work.
“Lack of FDA efficacy assessment will put the responsibility on the seller of the drug or device to prove its value to the physicians and patients and third-party payers, as opposed to responsibility being on a bunch of regulatory bureaucrats,” Hunt said. “It will subject the sellers of such drugs and devices to the civil litigation process that arises from false claims and useless interventions.”
Eliminating FDA’s efficacy requirement would also open the floodgates of quality assurance efforts by a limitless number of private parties, Hunt says.
“Pharma companies, Consumer Reports, Amazon.com, pharmacists, doctors, patients, third-party payers, and businesses built to support such efforts will all be involved with efficacy assessment,” Hunt said. “We don’t need bureaucrats to delineate value for drugs and devices. Bureaucrats are no wiser or brighter than anyone else, and they are more likely to be ideologically compromised by the compulsive power of their position.”
Craving Competition
FDA’s current drug-approval process makes it harder for small pharmaceutical companies than large companies to bring new drugs to market, Hunt says.
“Big Pharma has the size to field huge teams of ‘regulatory scientists’ to engage in subjective battles with subjective decisions of subjective FDA bureaucrats,” Hunt said. “Small pharma has to struggle with the sheer weight of the bureaucracy. This has caused small pharma to be little more than farm teams for the big pharma marketing powerhouses. It entirely distorts market forces within the pharma economy.”
Herrick says increasing competition and reducing market obstruction by FDA will drive down costs for the priciest drugs.
“Drug prices are rising, especially high-cost specialty drugs,” Herrick said. “These are only 1 percent of drugs prescribed but will comprise nearly half of all drug spending in the next few years. The solution for reining in drug costs is more competition and less FDA bureaucracy.”
Hayley Sledge ([email protected]) writes from Dayton, Ohio.
Internet Info:
Devon Herrick, “How to Make New Drugs More Affordable,” Issue Brief No. 203, National Center for Policy Analysis, January 5, 2017: https://heartland.org/publications-resources/publications/how-to-make-new-drugs-more-affordable
This article has been updated.
Image via Thinkstock
