Will Trump Appoint a Great FDA Commissioner?

Marginal Revolution ^ | January 23, 2017 | Alex Tabarrok

[reaganaut1]

As someone who has written about FDA reform for many years it’s gratifying that all of the people whose names have been floated for FDA Commissioner would be excellent, including Balaji Srinivasan, Jim O’Neill, Joseph Gulfo, and Scott Gottlieb. Each of these candidates understands two important facts about the FDA. First, that there is fundamental tradeoff–longer and larger clinical trials mean that the drugs that are approved are safer but at the price of increased drug lag and drug loss. Unsafe drugs create concrete deaths and palpable fear but drug lag and drug loss fill invisible graveyards. We need an FDA commissioner who sees the invisible graveyard.

Each of the leading candidates also understands that we are entering a new world of personalized medicine that will require changes in how the FDA approves medical devices and drugs. Today almost everyone carries in their pocket the processing power of a 1990s supercomputer. Smartphones equipped with sensors can monitor blood pressure, perform ECGs and even analyze DNA. Other devices being developed or available include contact lens that can track glucose levels and eye pressure, devices for monitoring and analyzing gait in real time and head bands that monitor and even adjust your brain waves.

The FDA has an inconsistent even schizophrenic attitude towards these new devices—some have been approved and yet at the same time the FDA has banned 23andMe and other direct-to-consumer genetic testing companies from offering some DNA tests because of “the risk that a test result may be used by a patient to self-manage”. To be sure, the FDA and other agencies have a role in ensuring that a device or test does what it says it does (the Theranos debacle shows the utility of that oversight).

[Gaffer]

ANYONE to replace a Hussein Ubama choice is okay with me, frankly.

[PGR88]

I see FDA in action in the food industry.

FDA will aggressively push and propose highly increased regulation and control of the food industry in the name of food safety and bioterrorism. They are pursuing very marginal, or nonexistent, incremental increases in food-safety.

The next effect will simply be to limit supply, and once again put more power into the hands of large corporations and connected insiders, and while simply making food cost more.

[reed13k]

Pretty much the same on the device side. I’ve been doing inspection responses for 10 years now. I wrote the transition staff and told them that if they would inspect overseas for the same amount of time and depth that they do in the US then they might be able to reduce the number of injuries in the market.

Avg overseas inspection is 4-5 days, avg in the US has been more than 3 weeks at the facilities I’ve been involved in. Of course the longer they are there the more likely they will find some documentation that isn’t perfect.

[corkoman]

Great point about med devices. We are about to have an explosion of devices that empower individuals to know about their bodies and bodily processes.

Manufacturers of med devices have to overcome increasingly high obstacles to gain and maintain commercial clearances.

But when reduced to a smartphone appendage and App the lines are blurred and most people as dismayed at why the FDA would want to restrict the people from knowing about themselves.

It will ultimately lead to where we are all going: save money by learning the complexities of medicine and investing in tech that will help you manage yourself. THAT is where we are going to drive down medical COSTS. Yes, there will always be the risk of bad auto-diagnisis and self-treatments. But knowing more about yourself is going to be a huge jump in being able to manage the cost of being healthy.