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

• Author: Luke Dawson
• Pages: 803-837

803

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. STATUTORY FRAMEWORK: THE FOOD DRUG & COSMETIC ACT AND

THE FDA ......................................................................................... 807

1. The New Drug Approval Process .......................................... 808

2. Misbranding ............................................................................ 810

3. Off-Label Use: Benefits & Risks ............................................. 812

B. THE COMMERCIAL SPEECH DOCTRINE ............................................... 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. STRICT VS. INTERMEDIATE SCRUTINY: SORRELL’S IMPACT ................. 827

B. EVIDENCE OF INTENT VS. PROTECTED SPEECH .................................... 828

C. CENTRAL HUDSON APPLIED ............................................................ 829

D. SOLUTIONS ...................................................................................... 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-label1 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 settlements5 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 inc lude 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 a nd 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.