Sex, Drugs, and Commercial Speech: The Contested Discourse of Truvada

Joseph F. Lawless* 

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* Farnsworth Note Competition Winner, 2016.  Ph.D. Candidate 2022, College of William & Mary, American Studies; J.D. Candidate 2017, Columbia Law School; B.A., University of Pennsylvania, 2012.  The author thanks Professor Noa Ben-Asher of Pace Law School for her thoughtful comments on prior drafts and for her wonderful encouragement; gratitude is also extended to Professor Bernard E. Harcourt and Professor Patricia J. Williams of Columbia Law School, both of whom remain faithful interlocutors and generous mentors.  Finally, the author offers the most heartfelt thanks to the editorial staff of the Journal of Law and Social Problems, with particular appreciation to Tara Raam, for their herculean efforts during the editing process.

In January 2016, Michael Weinstein, president of the AIDS Healthcare Foundation (AHF), a globally influential HIV/AIDS policy organization, urged the Food and Drug Administration (FDA) to take legal action against Gilead Sciences, manufacturer of the HIV-prophylactic medication Truvada, for violations of the Food, Drug, and Cosmetic Act (FDCA). The violations the letter enumerated were in reference to a Gilead-sponsored video advertising campaign that, per the allegations, misrepresented the proper usage regimen of Truvada. Under constitutional precedent governing commercial speech vis-à-vis pharmaceutical marketing, such misrepresentation of a drug’s constitutes “off-label” speech, a form of promotional advertising subject to criminal sanctions. This Comment explores the implications of AHF’s claims in the context of recent changes to commercial speech doctrine. It contends that should the FDA act upon the allegations contained in AHF’s letter it would require the agency to argue in favor of a significant misapplication of commercial-speech doctrine, particularly with regard to the branding provisions of the FDCA. Because the FDA continues to harden its stance on off-label use and speech, and in light of policy changes potentially encouraged by the new presidential administration, an examination of how the FDA might respond to allegations of FDCA violation is crucial. This Comment concludes by observing that the significance of this analysis is only heightened when the drug under legal scrutiny is one like Truvada — a prophylactic medication potentially able to drastically reduce the rate of HIV contraction if rendered more widely available.

I. INTRODUCTION

At the outset, we must determine whether the expression is protected by the First Amendment.  For commercial speech to come within that provision, it at least must concern lawful activity and not be misleading.  Next, we ask whether the asserted governmental interest is substantial.  If both inquiries yield positive answers, we must determine whether the regulation directly advances the governmental interest asserted, and whether it is not more extensive than is necessary to serve that interest.[fn id = “70”]

Although the district court in Washington Legal Foundation was, at the time of its decision, applying the full scope of jurisprudential precedent then available,[fn id = “71”] the Supreme Court has since intervened in the domain of commercial pharmaceutical communications.[fn id = “72”]  This intervention has resulted in a multilayered constitutional analysis that has been modeled by the Second Circuit Court of Appeals and a district court within its jurisdiction.[fn id = “73”]  These three cases — Sorrell v. IMS Health Inc., United States v. Caronia, and Amarin Pharma, Inc. v. FDA — illustrate the more robust analysis now expected of federal courts considering restrictions on commercial pharmaceutical speech.  Of importance in Sorrell was the Supreme Court’s articulation of the relationship between the First Amendment and pharmaceutical marketing: “[s]peech in aid of pharmaceutical marketing . . . is a form of expression protected by the Free Speech Clause of the First Amendment.  As a consequence, [statutory restrictions on such speech] must be subjected to heightened judicial scrutiny.”[fn id = “74”]  This determination would undergird the reasoning articulated in both Caronia and Amarin and as well as propel a shift in the FDA’s regulatory regime in 2017.[fn id = “75”]

B. CONSTELLATING THE EFFECTS OF SORRELL IN THE SECOND CIRCUIT — UNITED STATES V. CARONIA AND AMARIN PHARMA, INC. V. U.S. FOOD & DRUG ADMINISTRATION

AHF’s letter alleges that Gilead’s video campaign, the contents of which will be discussed infra, misleads “viewers into believing that Truvada is safe and effective for use on a situational basis despite [Gilead’s] knowing that the drug is not approved for such use.”[fn id = “76”]  Such promotion, AHF argues, is proscribed by the FDCA.[fn id = “77”]  This question of the FDCA’s proscriptive jurisdiction was left unanswered in Sorrell, as the object of the Court’s consideration therein was the constitutionality of a state statute.[fn id = “78”]  However, in United States v. Caronia, the Second Circuit Court of Appeals addressed directly “whether . . . prosecution . . . under the FDCA only for promoting an FDA-approved drug for off-label use [could be] constitutionally permissible.”[fn id = “79”]  While the FDCA criminalizes misbranding or conspiring to misbrand a drug, the statute and its corresponding regulations do not explicitly proscribe off-label promotion.  Instead, 21 C.F.R. § 201.128, which addresses how a manufacturer’s intent may be evinced during a prosecution pursuant to the FDCA’s misbranding provisions, emphasizes an objective evaluation that “may, for example, be [buttressed] by labeling claims, advertising matter, or oral or written statements by such persons or their representatives.”[fn id = “80”]  Such analysis of the mens rea element of the misbranding offense necessarily implicates speech, which, as the Caronia court acknowledged, raises significant First Amendment concerns.[fn id = “81”]

Recognizing that construing the FDCA as criminalizing the mere promotion of a drug’s off-label use would pose a grave constitutional difficulty, the court offered a narrow interpretation of the statute as, pursuant to the doctrine of constitutional avoidance,[fn id = “82”] “not prohibiting and criminalizing the truthful off-label promotion of FDA-approved prescription drugs.”[fn id = “83”]  The court began its analysis by considering the two-step inquiry articulated in Sorrell, wherein a court is first to consider “whether the government regulation restricting speech [is] content- and speaker-based”[fn id = “84”] and then “whether the government ha[s] shown that the restriction on speech [is] consistent with the First Amendment under the applicable level of heightened scrutiny.”[fn id = “85”]  Importantly, the Sorrell Court did not flesh out the contours of this “heightened scrutiny,” instead noting only that the state statute in question would be “unconstitutional even under the lesser intermediate standard set forth in Central Hudson.”[fn id = “86”]  Though the Supreme Court appeared to indicate that its abridged analysis could supplant the four-prong test developed in Central Hudson, the Caronia court offered an ordinal and merged interpretation of the doctrinal frameworks, beginning with Sorrell’s two-step inquiry to determine whether a constitutional violation based on viewpoint-discrimination exists and ending with Central Hudson’s less rigorous examination to consider whether the government can justify its criminal proscription of off-label promotion.[fn id = “87”]

A determination of content-based discrimination turns on whether the FDCA “distinguishes between ‘favored speech’ and ‘disfavored speech on the basis of the ideas or views expressed.’”[fn id = “88”]  Under the government’s proffered construction, speech about government-approved uses of drugs would be permissible while speech about off-label uses would necessarily remain prohibited, even if off-label use was not prohibited per se.  This interpretation would have the express purpose of diminishing “‘the effectiveness of [off-label drug] marketing by manufacturers,” strongly suggesting that the FDCA’s regulation of commercial speech was content-based and therefore presumptively unconstitutional.[fn id = “89”]  That this construction would effect speaker-based discrimination was facially manifest — as the court noted, “it targets one kind of speaker — pharmaceutical manufacturers — while allowing others to speak without restriction.”[fn id = “90”]  The court leveraged the Sorrell analysis to repudiate the government’s construction of the FDCA, and, after rejecting this reading of the statute, it turned to Central Hudson to determine whether the government could nevertheless pursue criminal sanctions under an alternative reading of the FDCA.  Insofar as the government’s position advocated the criminalization of off-label promotion, it could not be squared with its curious acquiescence in the dissemination of information regarding off-label use when requested by physicians;[fn id = “91”] accordingly, the court concluded that the government’s “criminal ban on off-label promotion by pharmaceutical manufacturers [was] more extensive than necessary to achieve [its] substantial interests.”[fn id = “92”]  The court ultimately construed the FDCA’s misbranding provisions “as not prohibiting and criminalizing the truthful off-label promotion of FDA-approved drugs.”[fn id = “93”]

A year prior to the decision in Caronia, Amarin Corporation (Amarin), a biopharmaceutical company, sought FDA approval for a single use of Vascepa, a drug it had developed to address cardiovascular health issues.[fn id = “94”]  Subsequent to the FDA’s authorization of Vascepa’s intended use, Amarin sought in 2013 an additional approval for Vascepa to treat a derivatively related cardiovascular condition; the FDA, however, denied Amarin’s application, stating that the clinical trials Amarin conducted failed to yield sufficient data to support the medical benefits of this second usage.[fn id = “95”]  In response, Amarin stated that it wished at minimum to include the results of those clinical trials on Vascepa’s label to better ensure that physicians were aware of the drug’s positive indication for multiple cardiovascular conditions.[fn id = “96”]  In 2015, the FDA issued a letter refusing Amarin’s request and further stated that, should the company market Vascepa for any usage other than the one approved by the agency, the company would expose itself to criminal liability for “misbrand[ing] under the FDCA.”[fn id = “97”]  Ten days after FDA’s implicit threat of prosecution, Amarin filed a civil suit in the Southern District of New York, claiming that “FDA’s threat of a misbranding action [was] chilling it from engaging in constitutionally protected truthful speech”[fn id = “98”] and seeking “an injunction that would prohibit the FDA from bringing a misbranding action against [the company] for its truthful and non-misleading statements to doctors regarding Vascepa . . . .”[fn id = “99”]

In granting Amarin’s application for preliminary injunctive relief, the district court rooted its analysis squarely in the precedent set by Caronia.  In order to establish the intent (mens rea) and act (actus reus) elements of a misbranding action, the FDA argued at trial that it could “use Amarin’s statements regarding Vascepa’s [second usage] as objective evidence of Amarin’s intent to promote [Vascepa] for [an] off-label purpose” and cite any “truthful and non-misleading statements about that use” made by Amarin as evidence of the act of misbranding itself.[fn id = “100”]  However, the court noted that, “under Caronia, the FDA may not bring such an action based on truthful promotional speech alone, consistent with the First Amendment.”[fn id = “101”]  The Caronia majority presented the issue as “whether a misbranding prosecution that identified a defendant’s speech alone as the proscribed conduct [could be] constitutionally permissible,” and the ensuing analysis held categorically that the FDCA’s misbranding provisions were not to be construed as reaching truthful speech promoting off-label use.[fn id = “102”]  Caronia is thus to be understood as a case of statutory construction that turned not on the mens rea requirement of the misbranding provision but rather on the actus reus requirement of that provision, and, because the court read the FDCA did not reach truthful, non-misleading speech promoting off-label uses, the FDA could not constitutionally pursue its threatened prosecution.[fn id = “103”]

IV. CONTESTING TRUVADA — CONSIDERING PHARMACEUTICAL SPEECH POST-CARONIA AND THE FDA’S NEW REGULATORY CALCULUS

A. A “BRAZEN NEW AD CAMPAIGN” — DETAILING THE CONTENT OF THE GILEAD-SUPPORTED VIDEO ADVERTISEMENTS

The AHF’s letter to the FDA regarding Gilead’s putative misbranding of Truvada, now written just over one year ago, has not yet incited a legal response from the agency.  Although the president of AHF, Michael Weinstein, addressed the letter to Stephen Ostroff, the then-Acting Commissioner of the FDA, there is no evidence the document was routed to the FDA’s Office of Prescription Drug Promotion (OPDP), the branch of the FDA charged with the review and surveillance of drug advertisement materials and thus the proper addressee.[fn id = “104”]  The FDA marshals the OPDP to run its “Bad Ad Program,” the purpose of which is “to increase the effectiveness of OPDP’s surveillance . . . especially with regard to curtailing inappropriate promotional activities” by allowing any individual to report misleading prescription-drug promotion.[fn id = “105”]  Assuming, arguendo, the AHF’s letter to the FDA can be taken as a form of reporting to the Program, the central investigative inquiry facing an OPDP reviewing officer would be whether the speech cited by AHF — three online videos, the production of which was financially supported by Gilead — encourage a use of Truvada inconsistent with the FDA’s approved usage.  A review of the videos produced for the advertising campaign is therefore useful in proceeding with the below analyses.

In total, Gilead appears to have sponsored the production of three videos by Public Health Solutions, a nonprofit organization based in New York City,[fn id = “106”] all of which addressed the question of whether Truvada was the right choice for an individual or a couple.  In the first video, an actor is seen collecting condoms and a small plastic bag of unidentifiable pills before heading out to a bar.[fn id = “107”]  The actor states that he “like[s] to party” while dancing at the bar.  In the following scene, he is seated at home, looking at his cellphone, which provides him with a reminder to take his daily dosage of Truvada.[fn id = “108”]  As the reminder appears on the screen, the actor states that he also “like[s] to be safe.”[fn id = “109”]  In the second video, a man is seen on his cellphone, facilitating a casual sexual encounter with another user of a cellphone application.[fn id = “110”]  After the two enter the man’s bedroom, he states to his paramour: “Hey . . .  I’m on PrEP.”[fn id = “111”]  When his partner admits to complete ignorance regarding Truvada, the man is shocked.[fn id = “112”]  The screen then cuts to a slide that offers a hyperlink for viewers to learn more about the medication.[fn id = “113”]  The third video is a series of crosscut interviews among several couples, all of whom are serodiscordant in HIV status.[fn id = “114”]  Each couple speaks about the multiple reasons why one might use Truvada or instead depend on condoms as the means of prophylaxis.[fn id = “115”]  One couple discusses the side effects of Truvada, after which an individual describes the three-month testing regimen for HIV status, as well as testing for kidney and liver health, that is medically necessary when taking Truvada.[fn id = “116”]  Perhaps most notable is when one member of a couple plainly states that he does not believe that Truvada is for everyone, as it requires an individual to have educated herself about HIV/‌AIDS and make the personal choice about what role she expects the medication to play in a serodiscordant relationship.[fn id = “117”]

B. THE VIABILITY OF AHF’S ALLEGATIONS AFTER CARONIA AND AMARIN

A determination of misbranding turns on a drug’s labeling; as mentioned, the FDCA defines “labeling” as “all labels and other written, printed, or graphic matter . . . accompanying [a drug].”[fn id = “118”]  At the outset, then, AHF’s linkage of the videos to Truvada’s labeling is legally sound.  Nevertheless, the primary allegation in AHF’s letter — that Gilead engaged in the purposeful misbranding of Truvada through Public Health Solutions’ video campaign — seems unsustainable upon a plain review of the three videos’ content.  In the letter’s concluding paragraph, AHF President Michael Weinstein characterizes the video campaign as misleading viewers into believing that Truvada “is safe and effective for use on a situational basis,” a point the letter earlier supports by reference to the content of the first video.[fn id = “119”]  The letter suggests that the small plastic bag the actor takes as he leaves his home contains recreational drugs, and, because the use of recreational drugs is assumed to be metonymic with a “cavalier attitude toward complying with the established PrEP regiment, consistent condom use, and regular testing,” the video necessarily “undermines the effectiveness of Truvada and expressly contradicts the approved usage of the drug.”[fn id = “120”]  While the suggestion that recreational drug use is integrated into certain sites of queer male culture is not without merit,[fn id = “121”] the chain of inferential reasoning the letter proposes is incoherent.  First, the conclusory statement that recreational drug use bears a relationship to an individual’s ability to adhere to a specific medical regimen is without support; second, the statement is intentionally written in bombastic fashion to veil the weaknesses of AHF’s legal arguments, which require the presence of misleading speech within the video and thus cannot be sustained.

As explained in Amarin, Caronia held that “the FDCA’s misbranding provisions cannot constitutionally criminalize, and therefore do not reach, the act of truthful and non-misleading speech promoting off-label use.”[fn id = “122”]  This conclusion necessarily followed from the Supreme Court’s prior observation that “[s]peech in aid of pharmaceutical marketing . . . is a form of expression protected by the Free Speech Clause of the First Amendment” and thus cannot be restricted absent a failure to satisfy the four parts of the Central Hudson analysis.[fn id = “123”]  AHF’s claim that Gilead promotes the situational use of Truvada as medicinally effective would, if before a court, likely be addressed under Central Hudson’s first prong, which queries whether the commercial speech under scrutiny is “more likely to deceive the public than inform it . . . .”[fn id = “124”]  The court in Caronia reiterated the axiom that “the First Amendment does not protect false or misleading commercial speech,” and the court’s construction of the FDCA affords no protection to the manufacturer who employs misleading communications in the promotion of an off-label use.[fn id = “125”]

The content of the first promotional video, though potentially referencing illegal substance use, certainly does not bind this provocative possibility to its representations of how Truvada is properly used.  The actor states that his enjoyment of socializing does not compromise his commitment to sexual safety, a message that the ringing of his cellphone’s daily reminder to take Truvada daily reiterates, a schedule clearly aligned with the medication’s prescription regimen.  Indeed, it may be that “partying” and “safety” are placed in such purposeful juxtaposition to demonstrate that the two are not irreconcilable — an individual can pursue autonomous sexual choices while remaining committed to bodily health and integrity.  Of equal consequence is that, in the context of the other two videos that constitute the advertising campaign, the messages presented in this first video appear intended to acknowledge the frank reality both of HIV/‌AIDS and of a strong desire to pursue enjoyment without sacrificing one’s sense of bodily care.

The crystallization of Caronia’s jurisprudential legacy as articulated in Amarin may have suffered partial erosion in mid-2016, when the Second Circuit Court of Appeals issued its decision in U.S. ex rel. Polansky v. Pfizer.[fn id = “126”]  The court there asserted in a footnote that its holding in Caronia, though having avoided the constitutional question presented by the FDCA’s potential implication of the First Amendment, had nevertheless “left open the government’s ability to prove misbranding on a theory that promotional speech provides evidence that a drug is intended for a use that is not included on the drug’s FDA-approved label.”[fn id = “127”]  A textual examination of Caronia, however, suggests that the court’s misrepresents the Caronia dicta.  The court in Caronia did not decide but rather assumed that a drug manufacturer’s promotional speech could be marshaled as evidence to prove that manufacturer’s intended use of a drug, a determination that would then support a criminal prosecution for mislabeling or misbranding.[fn id = “128”]  Although this difference in language is ostensibly minute, it effectively circumscribes the reach of Caronia’s holding.  Caronia is characterized as a case about simple promotional speech that does not seek to furtively supplant the particular use of a drug that the FDA specifically approved; this retrospective gloss once again opens the possibility of pharmaceutical marketing and speech to function as evidence of a criminal act.[fn id = “129”]

The essentially unanswered question of whether promotional speech may serve as the basis of a criminal prosecution or as partial evidence supporting a criminal prosecution leaves Gilead and, by necessary implication, Truvada in a precarious position.  Should AHF’s allegations be taken seriously, the nuanced rereading of Caronia in Polansky could allow the FDA to marshal the video campaign as a piece of criminalizing evidence — one of many that AHF has worked to compile and provide.[fn id = “130”]  Unsurprisingly, the FDA has taken notice of the jurisprudential ripples effected by Caronia.  In September 2015, the FDA issued a proposed rule that included amendments to the agency’s regulations regarding “intended uses.”[fn id = “131”]  In January 2017, the agency promulgated the rule in its final version, and the commentary accompanying the rule in the Federal Register offers useful insight into how the FDA will pursue misbranding allegations in the wake of Caronia.

C. POTENTIAL EFFECTS OF RECENT FDA RULEMAKING PROCEEDINGS AND THE JANUARY 2017 “INTENDED USES” FINAL RULE

In September 2015, the FDA initiated a rulemaking proceeding that had as one of its objectives the amendment of the agency’s “Intended Use” regulations.[fn id = “132”]  To better elucidate its position on the types of evidence that are permissibly considered in an intended-use determination, the agency then recommended the deletion of the final sentence of 21 C.F.R. § 201.128,[fn id = “133”] which stated:

But if a manufacturer knows, or has knowledge of facts that would give him notice, that a drug 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 drug which accords with such other uses to which the article is to be put.[fn id = “134”]

When first promulgated, the regulation sparked significant criticism from pharmaceutical companies because the final sentence, when literally read, appeared to hold that “a manufacturer’s mere knowledge of an unapproved use of its approved drug automatically triggers requirements for new labeling that in turn render distribution of that approved product unlawful . . . .”[fn id = “135”]  The FDA’s proposed deletion of that sentence intended to clarify that a manufacturer’s knowledge of physicians’ off-label use of a drug it had manufactured would not, by itself, trigger the FDCA’s labeling provisions.[fn id = “136”]  After reviewing the comments submitted in response to the proposed rule, the FDA ultimately decided to forego deletion of the sentence in favor of a detailed re-articulation that would “better reflect” how the agency has consistently applied its intended-use regulation.[fn id = “137”]  The final rule excised the former’s focus on manufacturer knowledge and articulated instead that an evaluation of “the totality of the evidence [can] establish[ ] that a manufacturer objectively intends that a drug . . . be used for conditions, purposes, or uses other than ones for which it is approved . . . .”[fn id = “138”]

Several comments to the proposed rule asserted that the FDA was constitutionally required to contract its proposed definition of “intended use” because of recent court rulings, including Caronia and Amarin.  The FDA’s response to these comments emphasized the agency’s express disagreement with “the assertion that the current case allow allows FDA to consider speech as evidence of intended use only when it is false or misleading,”[fn id = “139”] as articulated in Caronia.  The agency buttressed its claim with a citation to Polansky, quoting the language of the very same footnote that undermined the scope of the Caronia decision.[fn id = “140”]  Interestingly, after the Polansky court stated that Caronia left intact the government’s ability to prove misbranding through reliance on promotional speech as evidence, the court then cited the final sentence of 21 C.F.R. § 201.128, the FDA’s intended-use regulation, as analogous support for its argument.

The FDA’s citation to the Polansky footnote in its final rule curiously omitted any reference to court’s inclusion of the intended-use regulation — a somewhat glaring excision insofar as the agency altered the text of that very sentence.  The effect of Polanksy’s subtle circumscription of Caronia here becomes manifest, as the FDA was implicitly able to cite itself as judicial authority through its purposeful tailoring of the Polansky court’s footnoted text.  This reassertion of the evidentiary value of pharmaceutical speech further corrodes the protection afforded by Caronia.  Despite clearly addressing the constitutional complexities of off-label promotion throughout the text of the final rule, the FDA described the legal issues as sufficiently complex to merit a separate examination,[fn id = “141”] which the FDA initiated in September 2016.[fn id = “142”]

The newly altered version of 21 C.F.R. § 201.128 ostensibly provides some legal protection for drug manufacturers against discretionary enforcement actions for off-label promotion, but the FDA’s continuous equivocation in responses to comments on the rule’s proposed form suggests that the agency will not easily abandon its use of speech as prosecutorial evidence.  AHF’s assault on Truvada, though amenable to being categorized as politically reactionary, may function as an unexpected symbol of the entropic policy adjustments now characteristic of the current federal political climate.  Although the FDA took pains to describe its alteration of the intended-use regulation’s last sentence as a simple clarification of longstanding policy, a totality-of-the-evidence standard may, by virtue of the subjectivity involved in such an assessment, promote greater arbitrariness in the enforcement of FDCA prohibitions.  AHF is a powerful advocacy organization whose capacity to ignite unexpected sociopolitical change cannot be discredited,[fn id = “143”] and thus its sustained criticism of Truvada as the potential site of a second AIDS epidemic may tap into an internalized reservoir of AIDS-phobia potent enough to exploit the plasticity of the FDA’s purportedly “consistent” regulatory position.

V. OSSIFYING REGULATIONS OF OFF-LABEL SPEECH — CONCLUDING THOUGHTS ON THE IMPERILING OF TRUVADA AND COMMERCIAL SPEECH

On January 18, 2017, two days before the Trump administration took office and the regulatory ethos of the executive branch would begin to undergo substantive change, the FDA released an official agency document (entitled a “memorandum,” thereby reducing the scope of its regulatory significance to possibly nil) wherein it staked out its position on the First Amendment questions pertaining to off-label commercial speech.[fn id = “144”]  This document, which breaks years of agency silence on the specific question of the scope of First Amendment protection to which biopharmaceutical companies are entitled in the off-label marketing of approved drugs, suggests an attempt by the agency to place its views “on the record” before the change in administration results in an alternative approach; indeed, the memorandum may function to undercut the viability of any substantive change in the FDA’s position on off-label marketing, as significant changes in agency policy adversely affect the scope of deference afforded such changes.

The position the FDA articulates in its memorandum reflects the longstanding, implicit stance it has taken on off-label promotion: that the “government’s multi-faceted interests in the public health are substantial and . . . the relevant FDA Authorities directly advance many of those interests.”[fn id = “145”]  While it is certainly worthwhile to retain the rigorous standards of examination to which new medical drugs are subjected prior to their approval for placement within the national market, the FDA’s cursory dismissal of the legal questions addressed by the courts in Caronia and Amarin cast doubt on the FDA’s attempt at a reasonable, evidence-based analysis of the public-health concerns those cases raised.  The concern of heavily politicized bias within the domain of the FDA’s health policy determinations, augmented by the publication of the aforementioned Memorandum, led an organization of pharmaceutical companies and biotechnology corporations to file a petition to stay the implementation of the FDA’s Final Rule on intended use.[fn id = “146”]  According to the industry groups’ petition, the new standard the FDA will employ in its determination of a drug’s intended use, completed under a “totality of the evidence standard,” would allow anything to “be considered to establish a product’s intended use,”[fn id = “147”] thereby allowing the FDA “to rely even on non-promotional scientific exchange as evidence of intended use.”[fn id = “148”]  The chilling effect of such a standard is difficult to comprehensively imagine, as any kind of speech a pharmaceutical corporation engages in could be marshaled as evidence that the firm intended to misrepresent the manner in which the drug is approved to be used.

This new standard and the recalcitrance of the FDA to offer a more nuanced position on the relationship between the rights the First Amendment protects and the effects of those rights on commercial speech must be considered in contexts beyond those to which the FDA blithely alludes, such as those in which biopharmaceutical corporations seek the First Amendment as a shield to veil their exploitative efforts.[fn id = “149”]  A medication such as Truvada, which serves communities subject to multiple forms of social disqualification, is particularly vulnerable to the kind of attacks the FDA’s policy would allow — a concern that is undoubtedly aggravated in the new political context portended by the Trump administration.  The question here is thus not whether the FDA should or should not relax its standards regarding the proliferation of off-label speech; rather, it is whether the broad stroke the current policy effects may prove hazardous to continued access to drugs capable of changing the destruction experienced by communities that remain vulnerable to systemic exposure to illness and disease.  Further, this question must consider whether the FDA’s position may offer the new administration a sword against which to assault those biopharmaceutical companies not engaged in off-label speech, as conventionally envisioned, but engaged in providing medication and information to communities otherwise imperiled by lack of access to medical information and drug availability.