INTRODUCTION
In the wake of U.S. Supreme Court rulings finding personal injury failure to warn claims preempted by the Food and Drug Cosmetic Act (FDCA), new state law tort theories are emerging. None may be more potently poised to alter the medical product litigation landscape than purported state law tort claims for "off-label promotion." As the courts reexamine the power granted to the Food and Drug Administration (FDA) and limit the scope of its enforcement in light of Due Process and First Amendment considerations, state tort claims may find a new footing in the emerging void.
The FDA places restrictions on what, when, where, why, and who may disseminate information concerning regulated products. Over decades, the statutory and regulatory framework has expanded, placing more restrictions on information that may be disseminated. This expanding regulatory framework continually inches closer to infringing on constitutional protections. As enforcement and market competition increase, the tension among regulated industry, the regulators, the medical profession, and the consuming public has likewise increased.
Increasingly aggressive enforcement of marketing claims under the FDCA has ushered in a new era and a fresh look at how the FDA enforces rules governing labeling and the dissemination of truthful scientific and medical information concerning FDA-regulated products. Nowhere is the impact of this enforcement effort more profoundly focused than in connection with criminal and civil penalties for communicating reliable scientific and medical information, prosecuted and punished under the law as "unapproved" drugs and devices (i.e., "off-label promotion").
Off-label use presents a conundrum: Physicians, consumers, and even academia are unrestrained in recommending any product for any use, irrespective of whether there is scientific or medical support for the use. Manufacturers with reliable scientific and medical information regarding a use not in the FDA-approved labeling are throttled under the rubric of off-label promotion, and silenced or prosecuted. From this conundrum, an urgent moral and ethical imperative exists to provide more - not less - reliable scientific and medical information.
The provision of medical care implicates a number of stakeholders - manufacturers, health care providers, consumers, and government.1 The interplay among the stakeholders creates a discernible matrix. Manufacturers have varying degrees of knowledge concerning post-market experience and methods of disseminating information. Physicians' sophistication with regards to off-label uses and their motivation for doing so varies significantly as well. Consumers' understanding ranges from highly educated concerning the products they use to existing at the mercy of their doctors. The FDA sits in judgment of how the manufacturer informs health care providers and, increasingly, the public, through a set of rules, guidances, draft guidances, and policies that permit the exercise of discretion by the government to determine whether truthful medical and scientific information constitutes "false" information and evidence of criminal conduct. This complex matrix is on a collision course with fundamental Due Process and First Amendment principles. These constitutional underpinnings are increasingly poised to serve a vital role in furthering the public health and restricting the scope of government control and power, but with the right and financial incentive to speak, new obligations, duties and claims may arise.
I. FDA'S MISSION
In establishing the FDA, Congress set the "mission" of the FDA to:
promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner;2
protect the public health by ensuring that foods are safe, wholesome, sanitary, and properly labeled... drugs are safe and effective... there is reasonable assurance of the safety and effectiveness of devices... cosmetics are safe and properly labeled....;3
...reduce the burden of regulation, harmonize the regulatory requirements, and achieve reciprocal arrangements [with other nations];4 and
...carry out [its mission] in consultation with experts in science, medicine, and public health, and in cooperation with consumers, users, manufacturers, importers, packers, distributors, and retailers of regulated products.5
In defending the increasing regulatory landscape of the FDA, the commissioner has stated:
Now I know that in some circles regulation is viewed as a roadblock to innovation and economic growth. But in actuality, when done right, regulation isn't a roadblock; it's the actual pathway to achieving real and lasting innovation ... Going forward, smart regulation requires regulatory flexibility that responds to changing situations, new information and new challenges.6
II. OFF-LABEL USE: THE "PRESCRIBER'S PRIVILEGE"
The use of FDA-regulated products for purposes not in FDA-approved labeling is recognized as appropriate in the practice of medicine. In the prescription drug context, "clinically appropriate medical practice at times requires the use of pharmaceuticals for 'off-label' indications."7But that is not to say that when a physician prescribes a medication for a use or in a manner not approved by the FDA that she is not obligated to know she is prescribing a "new drug" and to be well informed. In its Guidance for Institutional Review Boards and Clinical Investigators, the FDA states:
Good medical practice and the best interests of the patient require physicians use legally available drugs, biologics and devices according to their best knowledge and judgment. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects.8
In published remarks, the now-former deputy commissioner of the FDA made a number of significant comments concerning the positive health benefits that result from relying on physician judgment in using products off-label, but concerning manufacturers' participation, he warned: "policy forces are tugging in exactly the opposite direction by placing restrictions on the exchange of some of the most pertinent information."9
In Buckman Co. v. Plaintiffs' Legal Comm., a case involving a medical device, the Supreme Court noted:
In effect, then, fraud-on-the-FDA claims could cause the Agency's reporting requirements to deter off-label use despite the fact that the FDCA expressly disclaims any intent to directly regulate the practice of medicine, see 21 U.S.C. § 396 and even though off-label use is generally accepted.10,11
While it has been long understood and recognized by the courts that "off-label" uses of medical products is accepted, in its Proposed New Drug, Antibiotic, and Biologic Drug Product Regulation, the FDA stated:
Current regulations are silent on the act's applicability to the use of approved drugs for unapproved uses. This issue has caused considerable confusion both inside and outside the agency. In the Federal Register of August 15, 1972,12 the agency proposed a regulation that would have put forth the legal status of approved labeling; although no final rule has been issued on this subject, the agency has continued to apply the principles set forth in the preamble to the 1972 proposal.In FDA's Drug Bulletin of April 1982, the agency sought to clarify and reiterate the position that the act does not regulate the 'practice of medicine.' Once a drug product has been approved for marketing, a physician may, in treating patients, prescribe the drug for uses not included in the drug's approved labeling. The primary legal constraints in that situation are State laws on medical practice and products liability law.13
It is significant that FDA has stated that the "act does not regulate the practice of medicine" but, instead, the profession polices itself with state tort law of "medical malpractice and products liability" as the backstop.
III. THE FIRST AMENDMENT
The command of the First Amendment relevant to this paper is a mere ten words: "Congress shall make no law ... abridging the freedom of speech ..."
As the Supreme Court continues its retreat from permitting wholesale bans on speech by commercial enterprises and wrestles with framing a coherent rule for when the government is permitted to silence a business enterprise, the marketplace continues to evolve in new and complex ways. Until recently, the FDA defeated challenges to the constitutionality of its regulation of speech by commercial enterprises using two tactics. First, the FDA has denied the applicability of constitutional protections altogether on the basis that marketing is conduct, not speech. Second, and in the alternative, the FDA has argued that if it is speech, the speech was not FDA approved and is therefore "false" and not entitled to First Amendment protection even under a lower level of scrutiny.14
While the legal framework protecting the speech of commercial enterprises has evolved over the past thirty years, it is only relatively recently that the courts have seriously considered applying the doctrine in the context of the FDCA:
Defendants' lead argument is that the Food, Drug, and Cosmetic Act violates the first amendment by restricting promotional materials to those that the FDA has approved. The argument starts from the premise that federal law allows customers of any approved medical device or drug to put it to any use that the customer sees fit. These 'offlabel uses' being lawful, the argument goes, it must be lawful to tell customers about them. Until the last 30 years, such an argument would have been laughed out of court.15
The laughter has stopped and, increasingly, the question is how to balance promotional and risk information:
The commercial marketplace, like other spheres of our social and cultural life, provides a forum where ideas and information flourish. Some of the ideas and information are vital, some are of slight worth. But the general rule is that the speaker and the audience, not the government, assess the value of the information presented. Thus, even a communication that does no more than propose a commercial transaction is entitled to the coverage of the First Amendment.16
Indeed, the Court has been skeptical of regulations that bar speech based on a paternalistic assumption concerning the inability of the consuming public to discern what is good for them:
Bans against truthful, nonmisleading commercial speech...usually rest solely on the offensive assumption that the public will respond irrationally to the truth. The First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good.17
Of course, the text of the First Amendment itself is silent on any distinction between individual and enterprise speech. For decades, enterprise speech, or "commercial speech," was assumed by the Supreme Court not only to exist, but to be fully within the power of government to restrict and control without much concern for the First Amendment. In the seven decades since the Supreme Court declared commercial speech not within the protections granted by the First Amendment, the Court has been gradually rethinking this issue and correcting its thinking, including abandoning some of its early pronouncements.
A. The Burden is on the Government
In those rare cases where a manufacturer raises the defense that FDA enforcement infringes its First Amendment protections, the burden falls on the government, not the manufacturer, to establish that its regulation meet the requirements of the First Amendment. In addressing this issue, the Supreme Court held that: "It is well-established that 'the party seeking to uphold a restriction on commercial speech carries the burden of justifying it.'"18 "If the First Amendment means anything, it means that regulating speech must be a last - not first - resort. Yet here it seems to have been the first strategy the Government thought to try."19
B. The Birth and Evolution of Commercial Speech
During World War II, in a case involving a submarine and a prior Justice Roberts, the Supreme Court in Valentine v. Chrestensen made a profound and admittedly erroneous assumption that has taken the Court decades to gradually walk back.20 In Valentine, the Supreme Court held:
[T]he Constitution imposes no such restraint on government as respects purely commercial advertising. Whether, and to what extent, one may promote or pursue a gainful occupation in the streets, (and) to what extent such activity shall be adjudged a derogation of the public right of use, are matters for legislative judgment.21
For decades after Valentine, the Court was confounded in cases involving a variety of commercial content and wrestled to frame a jurisprudential construct that would harmonize the text of the First Amendment while also permitting restrictions on the speech of commercial enterprises to conform to ever-changing social mores.
C. The Recognition of Commercial Speech
Thirty years after Valentine, in the 1976 ruling Virginia Pharmacy Board v. Virginia Consumer Counsel, the Court stated: "[a]s to the particular consumer's interest in the free flow of commercial information, that interest may be as keen, if not keener by far, than his interest in the day's most urgent political debate."22 In Bolger v. Youngs Drug Products Corporation, the Supreme Court noted that "beginning with Bigelow v. Virginia,23 this Court extended the protection of the First Amendment to commercial speech. Before that time, purely commercial advertising received no First Amendment protection."24
Forty years after pronouncing that commercial speech was not subject to First Amendment protection, in Schaumberg v. CBE, the Supreme Court took a very different view of the issue and pronounced Valentine and its progeny invalid:
To the extent that any of the Court's past decisions ... hold or indicate that commercial speech is excluded from First Amendment protections, those decisions, to that extent, are no longer good law.25
D. What Constitutes Commercial Speech
1. Bolger v. Youngs Drug Products Corp.
Bolger v. Youngs Drug Products Corp. is often cited for its definition of commercial speech and the three part test the Court articulated for determining if speech is commercial or noncommercial.26 In Bolger, Youngs Drug Products sent unsolicited mass mailings related to condoms despite a federal law that prohibited unsolicited advertisements for such contraceptives.27 Youngs brought an action for declaratory relief claiming that the statute, as applied, violated its free speech rights under the First Amendment.28
The Court found that "Because the degree of protection afforded by the First Amendment depends on whether the activity sought to be regulated constitutes commercial or noncommercial speech, we must first determine the proper classification of the mailings at issue here." Youngs sought to mail three types of materials:
1) A multi-page, multi-item flyer promoting a large variety of products available at a drugstore, including prophylactics;
2) Flyers exclusively or substantially devoted to promoting prophylactics;
3) Informational pamphlets discussing the desirability and availability of prophylactics in general or Youngs' products in particular.29
The Court found that although "[m]ost of appellee's mailings fall within the core notion of commercial speech - 'speech which does no more than propose a commercial transaction,'" the third category, informational pamphlets, could not be characterized merely as proposals to engage in commercial transactions.30
Footnotes
1 21 U.S.C. 393(b)(4).
2 21 U.S.C. § 393(1).
3 21 U.S.C. § 393(2)(A-D).
4 21 U.S.C. § 393(3).
5 21 U.S.C. § 393(b)(4).
6 Margaret Hamburg, M.D., 50 Years after Thalidomide: Why Regulation Matters, FDA VOICE (Feb. 7, 2012).
7 See Memorandum of the AMA House of Delegates, Resolution 820, Off Label Use of Pharm., Amer. Med. Assoc. (2005); see also Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 351 (2001); Sigma-Tau Pharm., Inc. v. Schwetz, 288 F.3d 141 (4th Cir. 2002); Huntsman v. Danek Medical, Inc., No. 97-2155-IEG, 1998 U.S. Dist. Lexis 13431 (S.D. Cal., July 27, 1998); Washington Legal Found. v. Kessler, 880 F. Supp. 26, 28 (D.D.C. 1995).
8 Off-Label and Investigational Use of Marketed Drugs, Biologics, and Medical Devices - Information Sheet, last accessed Feb. 10, 2013.
9 Scott Gottlieb, M.D., Deputy Comm'r Med. & Sci. Affairs F.D.A., Speech before Windhover's FDA/CMS Summit (Dec. 5, 2006).
10 Citing Green & Schultz, Tort Law Deference to FDA Regulation of Medical Devices, 88 GEO. L. J. 2119, 2133 (2000) ("Physicians may prescribe drugs and devices for off-label uses"); Smith, Physician Modification of Legally Marketed Medical Devices: Regulatory Implications Under the Federal Food, Drug, and Cosmetic Act, 55 FOOD & DRUG L. J. 245, 251-252 (2000) (discussing off-label use in terms of the "practice of medicine doctrine[, which] stands firmly for the proposition that regulatory efforts are directed primarily at device marketing by manufacturers, not device use by physicians"); Beck & Azari, FDA, Off-Label Use, and Informed Consent: Debunking Myths and Misconceptions, 53 FOOD & DRUG L. J. 71, 72 (1998) ("Off-label use is widespread in the medical community and often is essential to giving patients optimal medical care, both of which medical ethics, FDA, and most courts recognize").
11 531 U.S. 341, 351 (2001).
12 37 Fed. Reg. 16503.
13 21 CFR Part 312, Docket No. 82N-0394 (48 FR 26720) June 9, 1983. In prohibiting promotional activities related to investigational drugs, the rules state: "This provision is not intended to restrict the full exchange of scientific information concerning the drug, including dissemination of scientific findings in scientific or law media." 21 CFR 312.7
14 62 Fed. Reg. 64074, 64082.
15 U.S. v. Caputo, 517 F.3d 935, 937 (7th Cir. 2008) (emphasis added).
16 Thompson v. Western States Med Ctr., 535 U.S. 357, 367 (2002), citing Edenfield v. Fane, 507 U.S. 761, 767 (1993).
17 Thompson., 535 U.S. at 375, citing 44 Liquormart, Inc. v. Rhode Island, 517 U.S. 484, 501, 510-14 (1996).
18 Edenfield v. Fane, 507 U.S. at 770 (1993) (quoting Bolger v. Youngs Drug Prods. Corp., 463 U.S. at 71, n. 20 (1983)).
19 Thompson, 535 U.S. at 373.
20 Valentine v. Chrestensen, 316 U.S. 52 (1942).
21 Id. at 54.
22 Va. Pharmacy Bd., 425 U.S. 748, 783 (1976).
23 421 U.S. 809 (1975) (Bigelow v. Virginia, 421 U.S. 809 (1975)).
24 Bolger, 463 U.S. at 60.
25 Schaumberg v. Citizens for a Better Env't, 444 U.S. 620, 632 (1980).
26 See, e.g., Gibson v. Texas Dept. of Ins., No. 11-11136, 2012 U.S. App. LEXIS 22375 at *9 (5th Cir. Oct. 30, 2012)(citing Bolger, 463 U.S. at 60); see also Nike v. Kasky, 27 Cal. 4th 939, 956-57 (Cal. 2002).
27 Bolger, 463 U.S. at 61.
28 Id. at 63.
29 Id. at 62.
30 Id. at 66 (quoting Va. Pharmacy Bd., 425 U.S. at 762.)
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