The FDA cannot get out of its own way on the issue of off-label communications. Its power to punish off-label promotion comes from an odd regulatory two-step, whereby off-label promotions are said to prove an indicated use not included in the label and, thus, not accompanied by adequate directions for use – making the product misbranded. The tortured path of this ‘logic’ should, by itself, render this off-label regulatory regime questionable, but the FDA’s recent reaffirmance of it amounts to incoherent defiance.

The FDA takes the position that a company’s truthful, non-misleading statements about off-label use can constitute evidence of an intended use outside the label. Even while acknowledging that off-label use can be absolutely necessary for some maladies, and even while getting repeatedly clobbered by courts holding that truthful, non-misleading communications about off-label use are protected by the First Amendment, the FDA stubbornly asserts the power to clamp down on such speech.

The FDA’s effort to keep its clamp-down power has been clumsy. In 2015, the FDA proposed a rule regarding the scope of intended use. (We have been covering this issue all along. For example, here is a 2015 post by Bexis discussing how the FDA tip-toed into this area, hiding the off-label issue in a notice ostensibly about cigarettes. Good idea. After all, in the eyes of the anti-tobacco crowd, the First Amendment hardly exists for some companies.) One silver lining in the FDA’s proposed rule was that the FDA would “not regard a firm as intending an unapproved new use for an approved or cleared medical product based solely on that firm’s knowledge that such product was being prescribed or used by doctors for such use.” What a refreshing and rare connection to fairness and reality! It did not last. In the Final Rule published earlier this year, the FDA insists on its right to consider evidence of mere knowledge of off-label use as part of a dreaded “totality of the evidence” standard. Let the chilling commence.

But the effective date of this misguided Final Rule has been postponed until March 19, 2018. In the meantime, interested parties may comment. An extraordinarily thoughtful comment comes from the PhRMA organization, which represents pharmaceutical manufacturers. Perhaps some will resist reading PhRMA’s July 18, 2017 letter with objectivity, being biased about alleged bias, but you can read it here. You can see for yourself how the FDA’s not-so Final Rule runs counter to reality and the rule of law.

Here, in summary, are PhRMA’s main points:

1. FDA cannot establish an intended use absent an external statement by the manufacturer about that use.

The PhRMA letter does a nice job of marshaling precedent and historical practice to prove that the intended use of a product “can be manifested only if the manufacturer conveys that intent to someone who is in a position to buy” the product. Without that limiting principle, the FDA could attempt to establish a broader intended use via various internal communications. This is a concern we feel acutely when defending our clients against private party litigations. One reason that discovery is so ludicrously expensive and burdensome is that plaintiffs want to collect every internal document mentioning the product at issue, looking for some stray someone at sometime saying something that sounds bad, even though it does not represent a final position, or the position of the company at all. Mind-reading is a fool’s errand. The only reliable evidence is what the company actually said and did in terms of persuading others how to use its products. Forest Gump might say that ‘off-label is as off-label does.’ A more limited approach focusing on external statements makes sense, serves fairness and judicial economy and, perhaps most important, is fully supported by cases going back at least as far as 1920, ranging to include foods, drugs, and tobacco. For example, in American Health Prods. Co. v. Hayes, 574 F. Supp. 1498, 1505 (S.D.N.Y. 1983), the court read the term “intended” to refer to specific marketing representations. The PhRMA letter cites several other cases, and offers a compelling argument for a circumscribed interpretation of intended use – one based on reality rather than cynicism and innuendo. Even aside from the FDA regulatory issue, we wonder whether PhRMA’s argument might support our side in discovery disputes, or might assist us in drafting jury instructions where plaintiffs managed to smuggle allegations of off-label promotion into the case.

2. Overly restrictive regulation of truthful, non-misleading communications to health care practitioners about unapproved uses violates the First and Fifth Amendments.

Over the last decade-plus, courts have been constantly reminding all of us, including the FDA, that the First Amendment protects commercial speech, and that truthful, non-misleading communications about off-label uses are included in such protection. The hits just keep on coming. Not to put too fine a point on it, the FDA’s position on off-label communications has been thoroughly undermined by recent cases. The FDA’s exercise in wish-fulfillment simply cannot coexist with the SCOTUS opinion in Sorrell, which applied heightened scrutiny in striking down a law that restricted pharmaceutical manufacturer communications with healthcare professionals. The FDA’s “totality of the evidence” standard, besides being vague and overbroad, is certainly not the least restrictive means to protect the integrity of its drug approval process. The Second Circuit’s Caronia decision directly refutes the FDA’s policing of truthful, non-misleading communications about off-label uses. Apparently, all that the FDA can do in the face of Caronia is wish that it would go away. The SDNY decision in Amarin is similarly fatal to the FDA’s position. The PhRMA letter rips into the FDA’s efforts to prop up the proposed rule, laying waste to dicta and distinguishing away the few cases cited by the FDA. If this debate was a little league game, it would be called on the basis of the slaughter rule. But our concern is whether the FDA will dispassionately listen to the arguments and pay attention to the law. In truth, we are not certain that the FDA will approach this issue with even the fairness we expect to get in a little league game.