Is it a drug? Is it a device? No, it’s FDA’s subjective “chemical action” guidance

Device regulation used to be relatively simple. Not anymore.

As increasingly complex products hit the market combining drugs, devices and biologics, the U.S. Food and Drug Administration has been required to decide whether a particular product is truly a device under the jurisprudence of the Center for Devices and Radiological Health, or whether it is a drug or other combination product that should follow a non-CDRH regulatory pathway.

The agency made an effort to provide guidance on this matter when it released the “Interpretation of the Term ‘Chemical Action’ in the Definition of Device Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act” six months ago.

However, industry experts gathered at a morning panel at the University of St. Thomas, Minnesota on Wednesday believe that the guidance is very subjective and not particularly helpful to companies developing new products. (The event was organized by the university and trade association LifeScience Alley.)

That’s because what the FDA describes as a “chemical action” is very broad. The definition goes like this:

Through either chemical reaction or intermolecular forces or both, the product:

• mediates a bodily response at the cellular or molecular level, or
• combines with or modifies an entity so as to alter that entity’s interaction with the body of man or other animals.

In other words, if a product fits the above description, it is not a device.

To illustrate his point that the above definition could well mean whatever people want it to mean, Bob Klepinski, an attorney with Fredrikson & Byron, posed a question to the audience: “How many of you believe osmosis is a chemical reaction? How many of you believe osmosis is a physical action?”

The audience was evenly split.

That bodes the possibility that CDRH reviewers may not consider a new product approval application as a device. Andin a device-heavy region like Minnesota, the possibility of having a product be reviewed by any office other than CDRH is daunting simply because that is what companies are comfortable with.

The issue is complicated because the FDA is trying to draw a line in the sand, but where do you draw a line in a continuum? said Keith Hildebrand, senior principal scientist at Medtronic. He noted, however, that one thing is clear — if the product requires metabolism by the body to become active, then the product is not “just a device.”

Klepinski, who has been vocal about the increasing uncertainty of the FDA device review process, said that reasonably one may assume that precedence will be a factor in determining whether a product is a drug or device or combination product.

But based on recent history, it may well be up to the individual reviewer making these decisions, he said.