Why Congress quietly just gave the FDA more power

Sep 18, 2023

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Congress recently, and quietly, gave the FDA the power to prohibit off-label uses of medical devices.

"I think it's a move in the right direction," Randall Stafford says. "The FDA should be on the lookout for areas of off-label use where the benefits to harm balance is unclear and, in those cases, mandate further study."

But others say the new authority allows the FDA to interfere with the physician-patient relationship.

They're also concerned that the power could extend to prohibiting off label use of prescription drugs.

"That's truly arrogant to think that the federal government is the one and only one who knows better than the physicians at the state boards of medicine about what good medicine is or what it isn't," Brad Thompson says.

Today, On Point: Why Congress quietly just gave the FDA more power.

Zachary Brennan, senior editor at Endpoints News, where he covers the U.S. regulatory agency. (@ZacharyBrennan)

Randall Stafford, professor of medicine at the Stanford School of Medicine.

Brad Thompson, attorney at the firm Epstein Becker Green who counsels medical device and drug product companies on FDA regulatory issues.

Why Congress quietly just gave the FDA more power

Zachary Brennan: "There were actually a series of three major court cases that the FDA had lost and, you know, lost kind of a series of appeals related to the cases. And they had initially wanted to insert language into what's known as the user fee agreements, which occur every five years. And that's basically how the FDA gets paid by industry in order to meet certain deadlines for drug approvals.

"And so they tried to insert into that piece of legislation and Republicans blocked it. And then they, you know, got to the omnibus and, you know, were able to get two out of three of this reversal language into the omnibus. And yeah, I mean, I think this is just a very unprecedented thing that we don't see typically from the FDA where they're literally legislatively overturning court losses."

How much of expanded authority does it give FDA?

"It's strictly related to device regulation. And strictly related to the banning of devices. So, you know, I guess you can always kind of make the claim that there's a slippery slope to, you know, therapeutics and drugs and how the FDA regulates off label use and all of that. But, you know, just based on the language of what's in the omnibus, it just related to devices. So anything else is kind of a hypothetical. We'll see what happens in the future."

Generally, how does FDA determine those things?

Zachary Brennan: "This is kind of a missed misconception about the FDA. The FDA is a data driven agency run typically by MD's and PhD's. It's not, you know, bureaucratic paper pushers that are, you know, making decisions not based on the literature and not based on the data at hand. And as you mentioned earlier, you know, there have only been three devices, or two actual devices because they overturn the electrical stimulation one.

"But two other devices. One was powdered gloves and the other one was like prosthetic hair fibers back in the early '80s. So the FDA doesn't typically use this power very frequently. And I think it has, at least in the past, been used in cases where the data are kind of overwhelming. But, you know, again, they now have this new power. It's unknown what they're going to do with this new power. And it's very different from drugs, too. We see oftentimes a drug wins an accelerated approval, typically in oncology, and they have to run the confirmatory trial.

"And if the trial fails or if the trial succeeds, the drug can be pulled from the market very quickly. But doctors can continue to prescribe that drug for that indication. Even if it gets pulled. With devices, it's different. Once a device gets pulled, it then, you know, according to lawyers that I've spoken to, it then becomes illegal to use that device. So it is kind of a different way that the FDA regulates devices and drugs in that sense."

On device makers as important parts of FDA's funding

Zachary Brennan: "I think the FDA does very much rely on both the pharmaceutical and the medical device industries to provide them with adequate information. You know, the FDA doesn't have people sitting around combing through databases of hours looking for, you know, adverse events of medical devices, that sort of thing. So they're very much reliant on, you know, companies stepping forward and that's what the regulations kind of mandate that the companies have to do, you know, report X number of adverse events."

Describe to us how anything gets used off-label to begin with. How common is the practice?

Randall Stafford: "The practice is very common both for devices as well as drugs. And essentially an off-label use is a use of a device or drug for a particular clinical situation or indication that has not been scrutinized by the FDA in its clearance or approval process. And off-label use arises for a vast range of situations. There are situations in which a generic drug, for instance, may find new uses, and in that case, there's little incentive for the generic manufacturers to seek expanded approval or supplemental approval of a new indication for that drug.

"There are certainly cases where clinicians have utilized all existing remedies that are on label and are searching for ways to treat their patients. Outside of the usual indications approved by the FDA. Essentially the FDA approved indication is no longer work. And there's a certain type of innovation essentially looking for a remedy to help patients."

On an example of an off-label device

Randall Stafford: "Let me give you one example of a particular device whose use did rise in terms of off-label use. There's a particular stent that is actually manufactured for use in cancer of the bile system near the liver. This is a device that's meant to be palliative. That is, there's no sense in which this is curing a cancer, but it's allowing patients to continue to live and, in some sense, saving their liver from the usual consequences of the cancer.

"It was found that this device, this stent, which essentially is a wire mesh that keeps open a blood vessel or a bile duct, could be used in renal artery stenosis. And there was a time when use of this device off-label was very frequently used for the process of opening up a patient's renal artery to try to reverse a problem of kidney failure."

On FDA power to sell off-label devices

Brad Thompson: "I think one thing that we probably all auto agree on is that FDA has very strong control over the manufacturers and how they promote these products. They have the power during the approval process to define exactly what the label can say, what is on label. And then through their enforcement mechanisms, they have the ability to control really anything and everything that the manufacturer does in order to promote the product.

"And some of the biggest fines paid by drug and device companies have been for when they mess up and they promote something for an off-label use. There are literally hundreds of cases of such enforcement and the companies have to pay massive fines. So there really is no freedom here on behalf of the companies when it comes to these off label uses. The only issue is how folks who buy them can use them."

This program aired on February 10, 2023.