|Iontophoresis--Courtesy of Esthetica MD|
Iontophoresis--the use of electric current to deliver drugs--has come back under the FDA's radar as regulators look at whether restrictions for the decades-old technique should be eased with technology advances.
As reported from MedScape Medical News, the FDA held a hearing Feb. 21 in which an advisory panel recommended that the U.S. regulators take a softer line on iontophoresis devices at the local delivery level. The current classification--since 1983--has iontophoresis devices associated with a specific drug at class 2, which states that they aren't important enough to human health to outweigh potential risks. This puts them in the same category as jet injectors and infusion pumps.
But for the delivery of other drugs, the devices are class 3, which puts them in the same category as artificial disc replacements and implanted neurostimulators. These must undergo a full premarket application the way a new drug would.
The panel recommended bumping these electrophoresis devices down to class 2 for local drug delivery, treating them like any noninvasive device. It all comes down to this: it's an outdated rule that applies to now-advanced technology and new understanding. Historically, the FDA has classified it the way it would a syringe, and panel members feel that's now inaccurate.
"Part of the challenge here is historical … We're talking about biological reactions, such as with the immune system, that we didn't even know existed in 1976," private orthopedic physician William Rohr told Medscape. "We're trying to bring this up to a modern understanding of what's safe and efficacious. The challenge is, we don't yet have all of the data."
But the FDA panel feels enough data has been presented now on the safety of these devices to warrant reclassification. The adverse events most associated with iontophoresis are burns on the skin, according to the report, and studies have shown that skin reactions are mostly mild and don't require treatment.
So moving forward, the panel wants these devices to be classified under category 2 with "special controls" in place to account for any adverse events. Devices for systemic delivery will remain at class 3.
The main concern for members of the panel is that the iontophoresis devices are subjected to the same ruling no matter what kind of drug is used, be it the local pain drug lidocaine or one with such risks as the respiratory depressant fentanyl.
"Having a class 2 designation with special controls called out gives us a road map so that we can provide the needed information to the agency to appropriately assess our devices," the panel's industry representative Kathy Trier from Corin USA Limited told Medscape.
- here's the Medscape Medical News report