When we last examined the FDA’s sporadic effort to update the archaic “intended use” regulations (primarily 21 C.F.R. §§201.128 (drugs), 801.4 (devices)), the 2017 bait-and-switch amendment to these regulations had been put on ice. That has led to the bizarre Westlaw “currentness” notice for these regulations:
<Text of section effective upon the effective date of the amendment by 82 FR 2217, delayed indefinitely by 83 FR 11639.>
First, a brief orientation. As we’ve discussed, the FDA has largely given up trying to justify the sentence in these regulations that can be read as creating a new “intended use” based on nothing more than the regulated party’s knowledge of off-label use of its product. In 2015, it tried to sneak through such a change, hoping to avoid First Amendment-based comments. This Blog helped blow the whistle on that. The final rule, however, issued in January, 2017, three days before the new administration took power, was completely different – and much worse – than the proposal had received notice and comment. The new administration thus put that proposal into suspended animation – and that’s where it remained until just recently.
Last month the FDA decided to try again. See Regulations Regarding “Intended Uses,” 85 Fed. Reg. 59718 (FDA Sept. 23, 2020). First, the abortive 2017 final rule will be finally interred. “This action will . . . repeal and replace the portions of a final rule issued on January 9, 2017, that never became effective.” Id. at 59718. Second, the FDA proposes eliminate the mere knowledge language – without the 2017 bait and switch. Here is what the new language looks like, compared to what was previously on the books (ignoring the abortive 2017 attempted change):
The words intended uses or words of similar import in [relevant substantive regulatory sections] of this chapter refer to the objective intent of the persons legally responsible for the labeling of [drugs/devices] (or their representatives). The intent may be shown is determined by such persons’ expressions, the design or composition of the article, or may be shown by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. It Objective intent may be shown, for example, by circumstances in which the article is, with the knowledge of such persons or their representatives, offered or and used for a purpose for which it is neither labeled nor advertised; provided, however, that a firm would not be regarded as intending an unapproved new use for an approved drug based solely on that firm’s knowledge that such drug was being prescribed or used by health care providers for such use. The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer. If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom he or she received the [drugs/devices] article, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses. But if a manufacturer knows, or has knowledge of facts that would give him notice that a device introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a device which accords with such other uses to which the article is to be put.
Added language underlined, deleted language struck through, and language differing between drug and device-related regulations in brackets. The most critical additions and deletions are bolded.
Thus, the FDA appears to have reverted to the Agency’s original September 25, 2015, proposal simply to eliminate the 1950s-era “mere knowledge” language from its definitions of “intended use.”
Health care providers sometimes prescribe or use approved or cleared medical products for unapproved uses when they judge that the unapproved use is medically appropriate for their individual patients. In such circumstances, FDA does not consider a firm’s knowledge that a health care provider has prescribed or used its approved or cleared medical product for an unapproved use to be sufficient by itself to establish the intended use element of a prohibited act related to the lack of premarket approval or clearance.
85 Fed. Reg. at 59722. This time, however, the FDA is going about this directly, rather than hiding the proposal in an unrelated Federal Register notice (as it did in 2015). Back then, when the Blog helped blow the whistle on the FDA’s concealment, and encouraged commentators to force the FDA to address the First Amendment implications of defining “intended use” to criminalize truthful scientific speech about FDA-regulated products.
We don’t have to do that again. The FDA’s Federal Register notice this time around directly addresses the First Amendment. 85 Fed. Reg. at 59722-23. The FDA continues to stick with its increasingly discredited (see, e.g., our recent Facteau post) rationale that it’s OK to chill truthful speech by considering it “evidence” of intent. Id. As we pointed out at the time (and since), the Second Circuit flatly rejected that approach in United States v. Caronia:
[E]ven if speech can be used as evidence of a drug’s intended use, we decline to adopt the government’s construction of the FDCA’s misbranding provisions to prohibit manufacturer promotion alone as it would unconstitutionally restrict free speech. We construe the misbranding provisions of the FDCA as not prohibiting and criminalizing the truthful off-label promotion of FDA-approved prescription drugs.
703 F.3d 149, 168 (2d Cir. 2012). Instead, the FDA relies on dictum in a footnote in a subsequent opinion written by a judge who had dissented in Caronia. 85 Fed. Reg. at 59724 (citing United States ex rel. Polansky v. Pfizer, Inc., 822 F.3d 613 n.2 (2d Cir. 2016)).
Good luck with that.
We fully expect that the Medical Information Working Group, the Washington Legal Foundation, and others to make their First Amendment arguments by the time the comment period ends on October 23, 2020. If the FDA persists, then maybe the avenue for resolution of the First Amendment/truthful off-label speech issue once and for all will occur in the context of an Administrative Procedure Act appeal from the next FDA final rule. That would certainly be a safer way for the industry to litigate this issue than to run the risk of an actual criminal prosecution.