FDA Publishes Final “Intended Rule” with regards to Off-Label Marketing

FDA Publishes Final “Intended Rule” with regards to Off-Label Marketing

On August 02, 2021, the U.S Food and Drug Administration (FDA) issued its final “intended rule”. FDA amended its regulations with respect to describing the evidence which might be considered by the Agency for determining whether a corporation intended to market a prescription drug or medical device for use which FDA has not approved, authorized, or otherwise cleared (“off-label” use).

As per the existing rule, under the FDCA, a prescribed drug, biologic, or medical device has to be approved, authorized, or otherwise cleared by the FDA, for at least one intended use prior to its marketing and distribution by the company. Healthcare providers have been indulging in a common practice, i.e. “off-label use”. Under this practice, the providers prescribe drugs and devices for uses that are not included in the FDA approved product label. Such a practice is prohibited by the federal law[1], which prohibits distribution of drug or device into interstate commerce without prior label approval for its intended use. This is also known as “misbranding” and the federal government has been promoting enforcement actions against marketing or distribution of drugs and devices for off-label uses. A company would be liable for such a practice if the off-label use of the drug or device is inconsistent with the FDA-approved labeling and if it does not qualify as an “intended use” by the company. Therefore, it was high time for the FDA to bring out amendments to its “intended use” rule.[2]

The FDA first issued a revised final regulation on “intended use” in the year 2017. However, certain groups of the industry pleaded the FDA to reconsider the language of the 2017 language which indicated that the FDA would use a “totality of the circumstance” test to determine if a company intended for its medical product to be used off-label. Therefore, FDA delayed the effective date of the 2017 final rule and reopened the docket for public comment. Later, in September 2020, it issued a new proposed regulation that dropped the “totality of the evidence” language. The latest rule is largely unchanged from the September 2020 proposed rule.

In its final rule, the FDA introduced the following language to the “intended use” regulations, “[A] firm would not be regarded as intending an unapproved new use for [a medical product that is approved, cleared, granted marketing authorization, or exempted from premarket notification] based solely on that firm’s knowledge that such [product] was being prescribed or used by health care providers for such use.” This is to clarify that a manufacturer’s, distributor’s, or other seller’s knowledge that a product is used for off-label purposes does not by itself give rise to FDCA violations. The new regulation further amends to provide that a company’s intent for off-label use may be shown not only by the company’s “labeling claims, advertising matter, or oral or written statements” of the impugned drug or device and evidence concerning the “circumstances surrounding the distribution” of the product, but also by the “design or composition of the product”. Under the new regulation, the FDA would lay as to which evidence will be relevant to determine if a company is engaging in an off-label promotion, on a case-by-case basis, and from the viewpoint of whether a reasonable fact finder will decide if a seller or manufacturer intended the produce to be used for off-label purposes.

The final “intended rule” issued by the FDA is a welcomed step in providing important guidance for stakeholders in the pharmaceutical and medical device industries, including manufacturers and other entities in the supply chain for a drug or device subject to FDA approval, authorization, or other clearance. It clarifies that FDA would not conclude a company’s intent to sell its product off-label only based upon that the impugned product is being prescribed and sold off label. It would remain as a factor in reaching upon the determination and FDA would look into “any relevant source of evidence”, which is a standard set forth in case laws. The final rule would become effective on September 01, 2021, thirty days after its publication in the Federal Register on August 02, 2021.

[1] 21 U.S.C. §§ 331(a), 352(a)

[2] 21 C.F.R. §§ 801.4 (devices) and 201.128 (drugs)