A Spoonful of Free Speech Helps the Medicine Go Down: Off-Label Speech & the First Amendment

A Spoonful of Free Speech Helps the Medicine Go Down: Off-Label Speech & the First Amendment Luke Dawson  ABSTRACT: For over a decade, drug manufacturers have maintained that Food and Drug Administration (“FDA”) regulations restricting their ability to promote prescription drugs for off-label uses violate the First Amendment. Courts faced with First Amendment challenges to the FDA’s off-label speech restrictions have been reluctant to declare them facially unconstitutional. These courts fear that declaring such restrictions facially unconstitutional will undermine the FDA’s process for assessing and approving new drugs to the public’s detriment. However, relying in part on the recent Supreme Court decision in Sorrell v. IMS Health Inc. , the Second Circuit held in United States v. Caronia that the FDA’s speech restrictions, at least in some cases, violate drug manufacturers’ First Amendment rights. Sorrell raised serious questions as to whether a court should apply strict scrutiny in addressing the constitutionality of the FDA’s off-label speech restrictions. In light of these questions, this Note argues that courts addressing First Amendment challenges should not interpret Sorrell to require strict scrutiny in the off-label context and should continue to adjudge the FDA’s off-label restrictions under Central Hudson ’s less-exacting, commercial speech framework. This Note concludes that, even by Central Hudson ’s standard, the FDA’s off-label restrictions violate drug manufacturers’ First Amendment rights, and it proposes several ways the FDA and Congress may bring current law into conformity with the First Amendment.  J.D. Candidate, The University of Iowa College of Law, 2014; B.S.B.A., Drake University, 2011. I would like to thank my family for their continued support and the members of the Iowa Law Review for their efforts in improving this Note. 804 IOWA LAW REVIEW [Vol. 99:803 I. INTRODUCTION ...................................................................................... 805 II. STATUTORY FRAMEWORK AND THE COMMERCIAL SPEECH DOCTRINE ... 807 A. S TATUTORY F RAMEWORK : T HE F OOD D RUG & C OSMETIC A CT AND THE FDA ......................................................................................... 807 1. The New Drug Approval Process .......................................... 808 2. Misbranding ............................................................................ 810 3. Off-Label Use: Benefits & Risks ............................................. 812 B. T HE C OMMERCIAL S PEECH D OCTRINE ............................................... 813 1. Central Hudson and Thompson v. Western States Medical ......... 814 2. Sorrell v. IMS Health : A Game Changer? ................................ 815 a. Vermont’s Act ..................................................................... 816 b. Strict Scrutiny: Evidence of Viewpoint Discrimination .......... 817 c. Intermediate Scrutiny .......................................................... 817 III. FIRST AMENDMENT CHALLENGES TO THE FDA’S OFF-LABEL SPEECH RESTRICTIONS ........................................................................................ 820 A. WASHINGTON LEGAL FOUNDATION V. FRIEDMAN .......................... 820 B. UNITED STATES V. CAPUTO ............................................................ 823 C. UNITED STATES V. CARONIA ........................................................... 824 IV. ANALYSIS & SOLUTION ........................................................................... 826 A. S TRICT VS . I NTERMEDIATE S CRUTINY : SORRELL ’ S I MPACT ................. 827 B. E VIDENCE OF I NTENT VS . P ROTECTED S PEECH .................................... 828 C. CENTRAL HUDSON A PPLIED ............................................................ 829 D. S OLUTIONS ...................................................................................... 832 1. Less Restrictive Speech Regulation ....................................... 833 2. Economic Incentives .............................................................. 834 3. Drawing the Line Elsewhere .................................................. 836 V. CONCLUSION ......................................................................................... 836 2014] A SPOONFUL OF FREE SPEECH 805 I. INTRODUCTION For over a decade, drug manufacturers have argued that Food and Drug Administration (“FDA”) regulations restricting manufacturers’ ability to promote off-label 1 uses of prescription drugs violate manufacturers’ First Amendment rights. 2 Drug manufacturers and individuals have repeatedly raised First Amendment challenges to the FDA’s regulations. 3 In the district courts, drug manufacturers have obtained both favorable and unfavorable rulings. 4 However, until recently, the FDA forestalled drug manufacturers from obtaining a favorable circuit court decision by “deftly maneuver[ing] around” appeals, either by forcing settlements 5 or modifying interpretations of regulations and guidance documents to make challenges “disappear[].” 6 United States v. Caronia , however, did not disappear. 7 Rather, in Caronia , the Second Circuit rendered a 2–1 pro-manufacturer decision. 8 In doing so, the Second Circuit fulfilled drug manufacturers’ and free-speech proponents’ hopes that Caronia would produce groundbreaking precedent 1. The term “off-label” denotes the practice of prescribing drugs for uses not “approved by the FDA.” Randall S. Stafford, Regulating Off-Label Drug Use—Rethinking the Role of the FDA , 358 NEW ENG. J. MED. 1427, 1427 (2008). The FDA requires that a drug’s label include all of the drug’s FDA-approved uses. See 21 U.S.C. § 355(d) (2012). Thus, a physician who prescribes a drug for an unapproved use prescribes a drug for a use that is necessarily “off-label.” Conversely, the term “on-label” denotes the practice of prescribing a drug for an FDA-approved use. 2. See Jacqueline R. Berman, First Amendment Off-Label Promotion Cases Work Their Way Through the Courts , J. HEALTH CARE COMPLIANCE, Mar.–Apr. 2012, at 33; A. Elizabeth Blackwell & James M. Beck, Drug Manufacturers’ First Amendment Right to Advertise and Promote Their Products for Off-Label Use: Avoiding a Pyrrhic Victory , 58 FOOD & DRUG L.J. 439 (2003); Jose Sierra, The First Amendment Battle over Off-Label Promotion , PHARMARISC.COM (Dec. 14, 2011), http://pharmarisc. com/2011/12/off-label-promotion-as-a-government-weapon; Sally Wang, Let the Arms Race End: Opening the Door to Flexible Drug Marketing Regulation Through an IP Justification , JOLT DIGEST (May 25, 2012), http://jolt.law.harvard.edu/digest/digest-comment/let-the-arms-race-end-opening-the-door-to-flexible-drug-marketing-regulation-through-an-ip-justification. 3. See, e.g. , United States v. Caronia, 703 F.3d 149, 160 (2d Cir. 2012) (using the First Amendment as a defense in a criminal misbranding case); United States v. Caputo, 288 F. Supp. 2d 912, 919 (N.D. Ill. 2003) (same); Wash. Legal Found. v. Friedman ( WLF I ), 13 F. Supp. 2d 51, 54 (D.D.C. 1998) (seeking, in a declaratory judgment action, an injuction preventing the FDA from enforcing off-label policies); Memorandum of Law in Support of Plaintiff’s Motion for Preliminary Injunction at 11, Par Pharm., Inc., v. United States, No. 1:11-cv-01820 (D.D.C. filed Oct. 14, 2011) [hereinafter Par-Pharm Plaintiff’s Memorandum] (seeking, in a declaratory judgment action, an injunction preventing the FDA from enforcing off-label regulations). 4. Compare Caputo , 288 F. Supp. 2d at 922 (holding that the FDA’s off-label promotion restrictions do not violate the First Amendment), with WLF I , 13 F. Supp. 2d at 73–74 (holding that the FDA’s guidance documents violate the First Amendment). 5. Sierra, supra note 2. 6. Wash. Legal Found. v. Henney, 202 F.3d 331, 335 (D.C. Cir. 2000); see also Sierra, supra note 2. 7. See generally Caronia , 703 F.3d 149. 8. See id. at 168–69; see generally Blackwell & Beck, supra note 2. 806 IOWA LAW REVIEW [Vol. 99:803 in the world of off-label promotion. 9 Over a strong dissent, the Caronia court held the government’s use of the Food Drug and Cosmetic Act (“FDCA”) to prosecute drug manufacturers for promoting the lawful, off-label use of FDA-approved drugs violated the First Amendment. 10 Although drug manufacturers won the battle in Caronia , the war is far from over. 11 A primary point of contention in the ongoing dispute over off-label speech is the standard of scrutiny applicable to the FDA’s regulations. 12 A recent Supreme Court decision, Sorrell v. IMS Health Inc. , further confused the issue by suggesting courts may need to apply strict scrutiny in addressing the constitutionality of the FDA’s off-label speech restrictions while still, ultimately, assessing the constitutionality of the law in question under intermediate scrutiny. 13 Several commentators urge that Sorrell requires courts to apply strict scrutiny when reviewing the constitutionality of restrictions on off-label speech, despite the fact that commercial speech restrictions—like those the FDA imposes on drug manufacturers—are typically subject to intermediate scrutiny. 14 The Second Circuit’s Caronia opinion adopted this view. 15 This Note demonstrates, however, that the Sorrell Court was uniquely concerned with viewpoint discrimination. Thus, courts reviewing First Amendment challenges to off-label speech restrictions should interpret Sorrell narrowly and continue to apply intermediate scrutiny to FDA regulations. This Note addresses the First Amendment concerns implicated by the FDA’s off-label speech restrictions and argues the FDA’s off-label speech restrictions are unconstitutional even under intermediate scrutiny. Part II explains the impact of the FDCA and surveys the development of the commercial speech doctrine. Part III explores three First Amendment 9. See John R. Fleder, New Twists and Turns in Off-Label Marketing , FDA L. BLOG (Sept. 21, 2011, 1:43 PM)...