Auchincloss: Expedited Drug Program a ‘Poisoned Chalice’
Democratic Rep. Jake Auchincloss says a new FDA program to expedite the drug review process is bad for medicine and the FDA’s credibility.
Skepticism is growing on Capitol Hill about a new Food and Drug Administration program that aims to expedite the process for reviewing new drugs. The Commissioner’s National Priority Voucher program, introduced last year, has promised drugmakers expedited reviews of one to two months for new medicines that support “national interests.”
But Democratic Rep. Jake Auchincloss of Massachusetts, a member of the House subcommittee on health, says the program is motivated by prices and politics rather than science and is ultimately illegal. He spoke with U.S. News about the platform in February. The interview has been edited for length and clarity.
Can you explain what the program is?
The program basically short-circuits the traditional review process, at the commissioner's say-so, to provide a subset of drugs accelerated review.
It's actually very hazy what exactly “accelerated” means, because when we dig into the actual process – and we've met with FDA staff about this – it's not actually that clear how much time they're actually taking out of the process.
This is very worrisome because what it seems to really imply is that what you're really getting is not so much time saved as a higher likelihood of a yes.
Where do your concerns lie?
The question is: Why would the commissioner dole out a higher likelihood of a yes? It really is the commissioner’s to dole out, because this review board is political people who report to him. They're not career scientists.
The reason he's doling out an increased probability of a yes is that it's tied to pricing. He is trying to score wins for the White House and the way he's doing that is by doling out approval cards. Then you get a call from the White House or the Centers for Medicare and Medicaid Services saying they want to launch a price deal.
The problem with that is that it's illegal. The FDA can't do that. The FDA has to evaluate drugs based on safety and efficacy – not on any consideration of price.
You sent FDA Commissioner Marty Makary two letters last year outlining your concerns with the program. Can you tell us about the first two and why you felt the need to send another?
Because they haven't responded. Over the course of these three letters, we've learned more and more from whistleblowers, from public reporting and from industry feedback.
What's plain is that, one, the program's illegal. It doesn't have congressional authority. Two, it is a political end run around career scientists. Three, that political end run is directly linked to political considerations in the White House.
Why should consumers care about the people who vote on drug approvals?
Because patients, when they are taking a drug, and physicians, when they're prescribing the drug, are trusting in the standards of safety and efficacy that have made the FDA the world's gold standard biomedical regulator. Those standards are based on toxicology studies in animals, safety studies in humans, efficacy studies in humans, and then finally on randomized, controlled trials that show efficacy beyond the standard of care.
There are tons of different things the FDA can do to make it better, but they have gotten to a place where other countries around the world actually trust the rulings, because they know how rigorous they are.
When it's political appointees, then patients have less confidence, because the White House is looking for a short-term win rather than long-term safety and efficacy.
Are the concerns you have worth pausing the program over?
Yes, because it's a short-circuiting scientific review. That's not just a bad thing for the medicines under consideration, it's also a bad thing for the credibility of the FDA in the long run.
I share the commissioner's goal to get innovation to market. In my district, biotech companies get started on the sidelines of soccer games. There is no area of the country that wants pro-innovation regulation in biotechnology more than mine.
But what actually benefits innovators is highly transparent, science-driven standards. They want earlier and more responsive feedback from FDA regulators about what the biomarkers and endpoints are, they want it to be faster to get approval to go into preclinical and Phase 1 trials, and they want it to be easier to enroll patients in Phase 3 trials.
All of these are things, by the way, that I'm working on and that can and will be done in a bipartisan way. The wrong way to do it is to basically short-circuit and lower standards, because what that ends up becoming is a tax on innovators and a premium for snake oil salesmen.
How do you think this secrecy will affect the industry? Can hospital leaders remain confident regarding FDA decisions that influence hospital formulary and treatment strategies?
I think any medicine approved under the program is going to have to be reconsidered.
Could health providers face increased legal or clinical liability if they choose to adopt drugs approved through this pathway that later present problems?
I'm not a provider liability expert, so I'm not going to comment on that. What I will say is that the industry should not have confidence in the program. I think it's a poisoned chalice.
What does Commissioner Makary or the FDA as a whole have to do going forward to ease the concerns of the healthcare industry and Capitol Hill when it comes to this program?
Commissioner Makary should resign.
You’ve partnered with Republicans on things like the Pharmacists Fight Back Act. Why hasn’t there been bipartisan common ground on the Commissioner’s National Priority Voucher program?
It's a great question. On the FDA in general, Republicans have refused to hold a hearing. The No. 1 thing we need is a hearing. Makary needs to sit in front of the House health subcommittee and answer for his terrible stewardship.
But ultimately, it's on Congress to do the oversight and accountability measures. Republicans aren't acting yet. But if Democrats take back the gavel, we certainly will.
By: Aneeta Mathur-Ashton
Source: U.S. News & World Report