The FDA announced this week that it is reconsidering its classification of hyaluronic acid intra-articular products designed to treat pain in patients with osteoarthritis of the knee.
In the past, these HA products have been regulated as devices. But the U.S. regulatory agency said that the latest scientific literature clarifies that HA uses a chemical action within the body to relieve pain – putting HA products outside of the bounds of the FDA’s definition of a medical device.
The FDA said that sponsors of HA products who plan to submit a PMA or a supplement to a PMA for a change in indications, formulation or route of administration are encouraged to obtain an informal classification determination through a pre-request for designation or RFD prior to submission.
This change brings about important questions, according to Jeffrey Shapiro and Jeffrey Gibbs at the FDA Law Blog, who called the document “unusual.”
“As a procedural matter, this approach does not seem sensible. If FDA believes that new science requires the agency to re‑classify HA injectables for the knee as drugs, then it would make more sense to announce the concern, conduct a public proceeding to gather all the appropriate information and views, and make a class‑wide decision, with clear guidance on the transition and implementation of the decision. The sudden change without public input will deprive FDA of receiving broad feedback,” they wrote.
Shapiro and Gibbs also noted that the FDA seemed to suggest that the latest scientific literature applies across all HA products. If that’s the case, they wrote, then why bother deciding on a case-by-case basis?
They have other questions, too – what about the different quality and manufacturing standards set for device-makers compared to drug-makers?
“It is more than a little strange that the notice does not try to anticipate and answer the obvious practical questions that PMA‑holders will immediately ask,” Shapiro and Gibbs wrote.
The FDA’s move to reclassify HA products naturally brings about an even broader question, they concluded – will devices that are currently inappropriately regulated as drugs be reclassified?
“If this type of notice can be issued announcing an intent to consider reclassifying devices as drugs, then perhaps we will see additional notices in the coming years, announcing an intent to consider reclassifying drugs as devices. Over the years, we have expressed our concerns about the product jurisdictional process (for example, here). This notice only reinforces our concerns.”
