Washington Legal Foundation v. Henney

• Decision Date: 11 February 2000
• Docket Number: No. 99-5304,99-5304
• Citation: 202 F.3d 331
• Parties: (D.C. Cir. 2000) Washington Legal Foundation, Appellee v. Jane E. Henney, Commissioner, Food and Drug Administration, and Donna E. Shalala, Secretary, U.S. Department of Health and Human Services, Appellants
• Court: U.S. Court of Appeals — District of Columbia Circuit

Page 331

202 F.3d 331 (D.C. Cir. 2000)

Washington Legal Foundation, Appellee v. Jane E. Henney, Commissioner, Food and Drug Administration, and Donna E. Shalala, Secretary, U.S. Department of Health and Human Services, Appellants

No. 99-5304

United States Court of Appeals FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued January 10, 2000

Decided February 11, 2000

Appeal from the United States District Court for the District of Columbia(No. 94cv01306)

William B. Schultz, Deputy Assistant Attorney General, United States Department of Justice, argued the cause for appellants. With him on the briefs were David W. Ogden, Acting Assistant Attorney General, Douglas N. Letter and Michael S. Raab, Attorneys, Wilma A. Lewis, United States Attorney, Eric M. Blumberg, Deputy Chief Counsel for Litigation, Food and Drug Administration, and Annamarie Kempic, Associate Chief Counsel for Enforcement.

Bert W. Rein argued the cause for appellee. With him on the brief were Daniel J. Popeo, Richard A. Samp, Andrew S. Krulwich, Thomas W. Queen, Daniel E. Troy, and Michael L. Sturm.

Matthew Van Hook, Peter Barton Hutt, Bruce N. Kuhlik, and Michael S. Labson were on the brief for amicus curiae Pharmaceutical Research and Manufacturers of America.

Arthur B. Spitzer and Daniel I. Prywes were on the brief for amicus curiae American Civil Liberties Union of the National Capital Area.

Before: Silberman, Williams, and Tatel, Circuit Judges.

Opinion for the Court filed by Circuit Judge Silberman.

Silberman, Circuit Judge:

The government appeals a district court decision holding that the Food and Drug Administration Modernization Act of 1997, which establishes procedures by which drug and medical device manufacturers may disseminate information about "off-label" uses for their products, violates the First Amendment. In light of the government's appellate position that the statute does not provide it with independent authority to proscribe speech, we dismiss the appeal and vacate the district court's injunction.

* * * *

To secure Food and Drug Administration (FDA) approval for a drug or medical device,¹ a manufacturer must demonstrate that its product is safe and effective for each of its intended uses. See 21 U.S.C. § 355(d); id. at § 360e(e)(1)(A).It will often be discovered after initial FDA approval, however, that a drug has uses other than those for which it was approved. These so-called "off-label uses" are subject to asymmetrical--if not necessarily inconsistent--regulatory treatment. On the one hand, it is unlawful for a manufacturer to introduce a drug into interstate commerce with an intent that it be used for an off-label purpose, see id. at § 331(d), and a manufacturer illegally "misbrands" a drug if the drug's labeling includes information about its unapproved uses, see id. at § 331(a); id at § 352(a); cf. Kordel v. United States, 335 U.S. 345, 348-50 (1948) (affirming broad definition of "labeling" under the Food, Drug, and Cosmetic Act). On the other hand, neither Congress nor the FDA has attempted to regulate the off-label use of drugs by doctors and consumers. A physician may prescribe a legal drug to serve any purpose that he or she deems appropriate, regardless of whether the drug has been approved for that use by the FDA. See, e.g., Citizen Petition Regarding the Food and Drug Administration's Policy on Promotion of Unapproved Drugs and Devices; Request for Comments, 59 Fed. Reg. 59,820, 59,821 (1994). Although the parties have differing views about the health risks and benefits of off-label uses, it is undisputed that the prescription of drugs for unapproved uses is commonplace in modern medical practice and ubiquitous in certain specialties. See, e.g., James M. Beck & Elizabeth D. Azari, FDA, Off-Label Use, and Informed Consent: Debunking Myths and Misconceptions, 53 Food & Drug L.J. 71, 80 (1998).

While a manufacturer's direct advertising or explicit promotion of a product's off-label uses is likely to provoke an FDA misbranding or "intended use" enforcement action, manufacturers have sought to employ more indirect methods of informing physicians about their products' off-label uses. This case concerns the FDA's and Congress' attempts to regulate two of these promotional strategies: manufacturer dissemination to physicians of independent medical and scientific publications concerning the off-label uses of their products, and manufacturer support for Continuing Medical Education (CME) programs for doctors that focus on off-label uses. The FDA's examination of these practices led to publication of an agency enforcement policy set forth in three guidance documents. Two of these documents limited the circumstances under which manufacturers could permissibly distribute "enduring materials"--i.e., journal article reprints and textbooks--to physicians. See Guidance to Industry on Dissemination of Reprints of Certain Published, Original Data and Guidance for Industry Funded Dissemination of Reference Texts, 61 Fed. Reg. 52,800 (1996) ("Enduring Materials Guidances").² The third guidance document, concerning manufacturer involvement in CME programs (the "CME Guidance"), set forth twelve factors that the FDA will consider in determining whether a program is independent of manufacturer influence. See Guidance for Industry: Industry-Supported Scientific and Educational Activities, 62 Fed. Reg. 64,093, 64,096-99 (1997).

Washington Legal Foundation (WLF) brought this action asserting that the policies articulated in the Guidance Documents violated the First Amendment right of its physician members to receive information about off-label uses from manufacturers.³ Cf. Virginia State Bd. of Pharmacy v. Virginia Citizens Consumer Council, Inc., 425 U.S. 748, 756-57 (1976) (First Amendment protections extend both to distribution and receipt of commercial speech). The district court, in its decision granting summary judgment, began its discussion of WLF's constitutional claim by classifying the speech being regulated. Rejecting both the WLF's contention that the policies restricted fully-protected scientific speech and the FDA's argument that the speech was constitutionally unprotected because it "proposed an illegal transaction," the court determined that the Guidance Documents regulated commercial speech. See Washington Legal Foundation v. Friedman, 13 F .Supp.2d 51, 62-65 (D.D.C. 1998) (WLF I). It then applied the three-part test set forth in Central Hudson Gas & Elec. Corp. v. Public Serv. Comm'n, 447 U.S. 557 (1980), to determine whether the policies' restrictions on commercial speech exceeded constitutional limits. It concluded that the Guidance Documents satisfied the first and second parts of Central Hudson, since they directly advanced the government's substantial interest in encouraging manufacturers to seek FDA approval for off-label uses. They fell short of satisfying the final part of the Central Hudson test, however, because the policies restricted considerably more speech than necessary to encourage manufacturers to achieve this objective. See WLF I, 13 F. Supp.2d at 65-74. Holding that the Enduring Materials and CME Guidances violated the First Amendment, the court enjoined the FDA from prohibiting manufacturers' dissemination of enduring materials "regardless of whether such [materials] include[ ] a significant or exclusive focus" on off-label uses, and from proscribing manufacturers from suggesting content to CME program providers. Id. at 74-75.

Shortly after the district court issued its injunction, the Food and Drug Administration (FDA) Modernization Act of 1997, Pub. L. No. 105-115, 111 Stat. 2296 (FDAMA or the Act), became effective. The Act includes provisions concerning manufacturer distribution of enduring materials on off label uses that supersede⁴ the Enduring Materials Guidances found unconstitutional in WLF I. See 21 U.S.C. §§ 360aaa et seq. It specifically authorizes a manufacturer to disseminate "written information concerning the safety, effectiveness, or benefit of a use not described in the approved labeling of a drug or device," 21 U.S.C. § 360aaa(a), if it complies with several requirements: the manufacturer must submit an application to the FDA seeking approval of the drug for the off label use; the manufacturer must provide the materials to the FDA prior to dissemination; the materials themselves must be in unabridged form; and the manufacturer must include disclosures that the materials pertain to an unapproved use of the drug, and, if the FDA deems it appropriate, "additional objective and scientifically sound information ... necessary to provide objectivity and balance." See 21 U.S.C. § 360aaa(b)(1)-(6); id. at 360aaa(c); id. at 360aaa-1. Importantly, the Act amends the Food, Drug, and Cosmetic Act to prohibit "[t]he dissemination of information in violation" of these provisions. 21 U.S.C. § 331(z); see also id. at § 360aaa-4(b)(1) (emphasis added).

After the Act became effective, questions arose concerning the scope of the district court's decision and injunction in WLF I. The government asserted that the district court's ruling applied only to the Guidance Documents, two of which had been superseded by the Act, and asked that the district court confine the application of its injunction accordingly. The court denied the FDA's motion, noting that its "decision and injunction must be read to apply to the underlying policies of the FDA, and not merely to the express provisions of the Guidance Documents," Washington Legal Foundation v. Friedman, 36 F.Supp.2d 16, 18 (D.D.C. 1999) (WLF II), and requested supplemental briefing on the constitutionality of the Act's provisions addressing manufacturer promotion of off-label uses. In a subsequent opinion, the district court held that those provisions, like the Enduring Materials Guid-ances that preceded them, violated the First Amendment. See Washington Legal Foundation v. Henney, 56 F.Supp.2d 81 (D.D.C. 1999) (WLF III). The FDA appealed,...