We have more than a passing interest in FDA attempts to curtail speech, no matter the product. And when it comes to attempts to regulate speech relating to dietary supplements, it starts to feel awfully close to our drug and device wheelhouse, so our ears really perk up.
That’s why a recent case out of the District Court in the “District” (as the cool kids say), caught our attention. In Alliance for Natural Health US v. Sebelius, __ F. Supp. 2d __, 2010 WL 2110071 (D.D.C. May 27, 2010), a group of plaintiffs sought a declaratory judgment and injunction that would in essence force the FDA to allow plaintiffs to make “qualified health claims” regarding selenium-containing dietary supplements. Id. at *1. What do we mean when we say “qualified health claims?” Statements like: “Selenium may reduce the risk of certain cancers. Scientific evidence supporting this claim is convincing but not yet conclusive.” Id. at *6 n. 15. There were ten claims in all, a few of which were relatively broad (“certain cancers,” “anticarcinogenic effects”) and some of which were more specific (“e.g., “thyroid cancer,” “lung and respiratory tract cancers,” “breast cancer,” etc.). Id.
The FDA rejected seven of the ten claims outright. Id. at *6. That’s right; no attempt to temper the qualifying language or juice up the disclaimer, just a flat-out muzzle. With respect to the other claims, the FDA replaced the proposed qualifying language with a much-watered-down version that eviscerated the claim. For example: “Based on these studies, FDA concludes that it is highly unlikely that selenium supplements reduce the risk of prostate cancer.” Id. at *6 n. 19.
The plaintiffs, understandably annoyed at having their First Amendment rights trampled, sued the FDA and then moved for summary judgment. The FDA filed a cross-motion for summary judgment. The court issued a lengthy opinion analyzing each claim, but we’ll get to the punchline – FDA loses. With respect to the claims that the FDA flat-out quashed, the court remanded so that the FDA could either consider adding disclaimer language, or else come up with “empirical evidence” to show that no disclaimer could correct the claims’ “purported misleadingness.” Id. at *18. With respect to the claims that the FDA already watered down with disclaimers, the court remanded because the FDA’s qualifying language “replaced plaintiffs’ claim entirely” and thus “eviscerated plaintiffs’ claim.” Id.; id. at *18.
We’re not going to go blow-by-blow through the court’s analysis, but it is worth a read for anyone interested in this area. Here are the highlights:
History of FDA Regulation In This Area: The court wasn’t writing on a blank slate; the FDA has been embroiled in litigation with some of these plaintiffs going back to the mid-1990s. The court looked at prior decisions relating to the FDA’s regulation in this area – the bottom line is that prior courts had taken issue with the FDA’s loosey-goosey standards governing dietary supplement health claims. Those standards allowed the FDA to invoke magic words like “potentially misleading” to shut down speech unless there was “significant scientific agreement” with respect to a health claim. Id. at *2-3. The prior cases provide guidance about what passes constitutional muster – and the FDA’s loosey-goosey regulatory scheme doesn’t. We know that the First Amendment has a “clear preference for disclosure over suppression of commercial speech.” Id. at *5. In other words, it’s better to allow the speech to occur with appropriate disclaimers than to ban it out-right (sounds like a more measured regulatory position to take on off-label promotion, doesn’t it?). We also know that the government faces a “very heavy burden” if it wishes to totally suppress health claims. Id. at *4. And we know that the FDA can’t rely on speculation or the potential to mislead, but instead must offer qualitative, empirical evidence establishing that harm. Id. Finally, when looking at the evidence in support of a claim, the court may not uphold a speech ban unless that evidence is “outweighed by evidence against the claim” or is “qualitatively weaker.” Id.
Deference To Agency Decisions: The FDA argued that the court should apply the Administrative Procedure Act (APA)’s deferential standard – whether the FDA’s action was “arbitrary and capricious” – while the plaintiffs understandably argued that such deference was inappropriate because the FDA’s actions raised a constitutional question. Id. at *7. The court agreed it was obligated to conduct an independent review “without reliance on the Agency’s determinations as to constitutional questions.” Id. at *8 (citing J.J. Cassone Bakery, Inc. v. NLRB, 554 F.3d 1041, 1044 (D.C. Cir. 2009)). With respect to the Agency’s evaluation of scientific data, however, the court believed some degree of deference was due “provided such interpretation is reasoned and not arbitrary or capricious.” Alliance for Natural Health US, 2010 WL 2110071 at *8. Interestingly, though, the court ended up hanging the FDA with its own Guidance Document regarding the “evidence-based review system,” pointing out several instances where the FDA’s evaluation of evidence supporting the claims at issue deviated from the Guidance. Id. at *12-17. Bottom line – where the FDA’s conclusions are “contrary to its purported evaluation standards,” the court should pay no deference to those conclusions. Id. at *8. And that may be the most interesting takeaway from this opinion. The court really rolled up its sleeves, critically analyzing the FDA’s interpretation of each piece of evidence supporting the health claims, and critiquing the FDA for taking positions at odds with its own Guidance. See id. at *12-17. That failure, coupled with the failure to provide any empirical evidence to support the notion that disclaimers would be ineffective, doomed the FDA’s attempts to quash speech here.
First Amendment Analysis: Finally, we would be remiss if we didn’t mention that this case collects some good soundbites for anyone fighting FDA attempts to chill commercial speech. For example:
“The Supreme Court has ‘rejected the highly paternalistic view that government has complete power to suppress or regulate commercial speech.’” Id. at *9 (quoting Central Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n of N.Y., 447 U.S. 557, 562 (1980)).
“‘[T]he States may not place an absolute prohibition on certain types of misleading information…if the information also may be presented in a way that is not deceptive.’” Alliance for Natural Health US, 2010 WL 2110071 at *9 (quoting In re R.M.J., 455 U.S. 191, 203 (1982)).
“‘The First Amendment does not allow the FDA to simply assert that [a plaintiff’s c]laim is misleading in order to supplant its burden to demonstrate that the harms it recites are real and that its restriction will in fact alleviate them to a material degree.’” Alliance for Natural Health US, 2010 WL 211071 at *9 (quoting Whitaker v. Thompson, 248 F. Supp. 2d 1, 9 (D.D.C. 2002)).
And how about this troika, which seems pretty useful in the ongoing off-label promotion First Amendment battle:
“[D]isclaimers are ‘constitutionally preferable to outright suppression.’”
“‘[The preferred remedy is more disclosure, rather than less.’”
“‘[W]hen government chooses a policy of suppression over disclosure – at least where there is no showing that disclosure would not suffice to cure misleadingness – the government disregards a far less restrictive means.’”
Alliance for Natural Health US, 2010 WL 2110071 at *10 (quoting Pearson v. Shalala, 164 F.3d 650, 657-58 (D.C. Cir. 1999)).
We will be watching to see if any of the courts facing off-label issues (the Allergan and Caronia courts, at least) seize on any of this language, or the analysis in the Alliance for Natural Health US decision generally, when deciding whether the FDA’s off-label promotion regulations infringe on free speech rights.