Today, FDA issued a new proposed rule on the definition of intended use and how that will be ascertained for medical products. The regulatory definition is critical as the statute has, for over 100 years, defined the jurisdiction and scope of FDA regulatory authority by the sponsor's or promotors “intended use.” This history illustrates that a primary mission of the FDA is perceived within the agency as being the control of fraud – which predates concerns of safety (1936) and efficacy (1962). The existing definition of how the agency will identify the intended use is and has been largely based on the objectively perceived intent of the sponsor's from written, graphic, oral, or other communications by itself or through authorized representatives as to the use of the product. The existing definition also permits the FDA to identify the objective intent from knowledge by the sponsor that customers or others are using the product off-label or outside the intended use if action is not taken to correct. For instance, the company would have to post a correction on a blog relating to an off-label use. Or, as more commonly understood, avoid sales or promotion to physicians within a certain field if that specialty area has only off-label uses among their patients. Notwithstanding these potentially easier methods of avoidance, many companies have been concerned about the agency’s potential expansion of “objectively” determined intended use based on this asserted knowledge. At what level? Does the company have to scan the literature constantly, even outside the journals outside the label? The consequences of off-label promotion can be serious – seizure of the product, injunction against further distribution, criminal penalties, and disgorgement of revenue based on implicitly making false claims for government, i.e., Medicare or Medicaid, reimbursement.

In the prior iteration, the agency had continued this approach to great objection. The new proposed rule eliminates this interpretation of objective intent in part, by stating that the agency will not use such imputed “knowledge” as “solely” a basis for determining intended use and assessing or seeking the foregoing penalties. This is consistent with the agency’s position in briefing in cases in the 2nd Circuit where there was concern from the judges that such a sentence was overbroad when challenged under the First Amendment and the application of Central Hudson which interprets the First Amendment for commercial speech.

However, the new proposed rule does expand the existing version by adding factors such as “circumstances of distribution” and “composition of the article.” The former codifies the agency’s interpretation that visiting doctors who cannot prescribe on-label is a demonstration of fraudulent off-label promotion. For instance, a visit to a pediatrician’s office with an antifungal product not approved for use in children with an implied use for diaper rash. The latter codifies a more complex position of FDA, that has been hard to enforce, that the presence of an ingredient or similar name to an approved drug makes the potential non-drug, say, a dietary supplement, subject to the drug regulations. For example, a dietary supplement that makes claims to erectile dysfunction would clearly mean that the product is an unapproved new drug. But, if finalized, such a change would make the product misbranded even if no claims are made but contains sildenafil.

Hence, while not continuing the objectionable extension of intended use to “knowledge” of off-label use, the proposed rule does formally expand FDA’s medical product jurisdiction to foods, dietary supplements or other similar consumer products that contain approved drugs as ingredients or reference approved drugs. And formalizes the restriction on where sales people may venture.

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