Late last month, the US Food and Drug Administration (FDA) unveiled a new proposed rule that many in the pharmaceutical and medical device regulatory communities may have glanced over without a thought because it seemed to pertain only to tobacco products. But on a second look, the rule, if finalized, could have a major impact on the intended use regulations for drugs and devices.
For both drugs and devices, an intended use is determined by a manufacturer's expressions, including through labels, advertising, or oral or written statements made by a company or its representatives.
As the FDA Law Blog points out, determining what a medical product's “intended use” should be is fundamental to FDA’s regulation of drugs and medical devices as it's the "primary basis for determining if an article is regulated by FDA at all, and if so, what regulatory requirements apply."
But thanks to authority the agency gave itself, FDA can also regulate a product based on its actual uses, particularly if a manufacturer "knows, or has knowledge of facts that would give him notice, that a [drug or device] introduced into interstate commerce…is to be used for conditions, purposes, or uses other than the ones for which he offers it," and even if such uses are not claimed by the company, or in advertising or on a product's label.
That authority involves a somewhat gray area, which the Law Blog acknowledges "has been rarely enforced," though it leaves the door open for cases where FDA could say that a company's knowledge of a product's off-labels use would require a new marketing application for that use.
In one example of such a claim, device manufacturer DexCom was hit with a warning letter from FDA in which inspectors say they collected evidence finding that "your firm knows and has knowledge of facts that give notice that your device introduced into interstate commerce is being used for conditions, purposes, and uses other than the ones for which it is offered (ie. Off-label use in pediatric patients and use in body locations other than the abdomen)."
New Proposed Rule
However, FDA seems to be backtracking on that "knowledge" clause in this latest proposed rule from FDA, which is actually centered on cases where tobacco products might be subject to drug and device regulations.
FDA has proposed to basically re-work this sentence on a company's "knowledge" of a product's uses, and now says it "would not regard a firm as intending an unapproved new use for an approved or cleared medical product based solely on the firm’s knowledge that such product was being prescribed or used by doctors for such use."
FDA also clarifies that in establishing a medical product's intended use: "FDA is not bound by the manufacturer or distributor’s subjective claims of intent, but rather can consider objective evidence, which may include a variety of direct and circumstantial evidence. Thus, FDA may also take into account any circumstances surrounding the distribution of the product or the context in which it is sold."
And although the rulemaking focuses specifically on helping companies determine if a tobacco product falls under drug and device regulations, FDA notes this rulemaking "will provide clarity for drug and device manufacturers generally regarding FDA’s interpretation and application of its existing intended use regulations."
The agency also notes these "clarifying changes" around intended use would apply to drugs and devices and not just to tobacco products.
Such a dramatic shift in FDA's thinking seems to be a surprise for some, as the FDA Law Blog notes: "It is also remarkable that FDA provides almost no explanation for the proposed revision to the intended use regulations, considering that it is a fairly significant alteration to regulations that have been on the books for decades."
The blog also surmises that FDA's motivation behind the shift may "reinforce the position it has taken in recent First Amendment litigation" against Par Pharmaceutical, though even if it isn't linked to that litigation, the move seems to be a win for industry.
"Bottom line: it will now be undisputedly lawful to disseminate on‑label information (e.g., cleared or approved labeling) and/or otherwise promote an on‑label use to physicians, regardless of whether they may prescribe or use the product off‑label," the blog says.
Intended Use Proposed Rule
FDA Law Blog