Washington Legal Foundation v. Henney, CIV. A. 94-1306(RCL).

• Decision Date: 30 November 2000
• Docket Number: No. CIV. A. 94-1306(RCL).,CIV. A. 94-1306(RCL).
• Citation: 128 F.Supp.2d 11
• Parties: WASHINGTON LEGAL FOUNDATION, Plaintiff, v. Jane E. HENNEY, M.D., in her official capacity as Commissioner, Food and Drug Administration, and Donna Shalala, in her official capacity as Secretary, United States Department of Health and Human Services, Defendants.
• Court: U.S. District Court — District of Columbia

128 F.Supp.2d 11

WASHINGTON LEGAL FOUNDATION, Plaintiff, v. Jane E. HENNEY, M.D., in her official capacity as Commissioner, Food and Drug Administration, and Donna Shalala, in her official capacity as Secretary, United States Department of Health and Human Services, Defendants.

No. CIV. A. 94-1306(RCL).

United States District Court, District of Columbia.

November 30, 2000.

Richard A. Samp, Washington Legal Foundation, Washington, DC, for Plaintiff.

Daniel Franklin Van Horn, U.S. Attorney's Office, Washington, DC, for Defendants.

MEMORANDUM AND ORDER

LAMBERTH, District Judge.

Now before the Court is a motion by the plaintiff to confirm and enforce a permanent injunction issued by this Court on July 28, 1999. See Washington Legal Found. v. Henney, 56 F.Supp.2d 81, 88-89 (D.D.C.1999) ("WLF III"). The defendants claim that they are not in violation of the injunction, and therefore oppose the plaintiff's motion. After considering the parties' memoranda of points and authorities, and for the following reasons, the Court DENIES the plaintiff's motion.

BACKGROUND

This matter is yet another episode in a six-year controversy.¹ Beginning as far back as 1994, these two parties have sparred over the extent to which the federal government can regulate speech regarding the "off-label" uses of prescription drugs. The most recent dispute concerns two commands from the federal government: the Food and Drug Administration Modernization Act passed by Congress (the "FDAMA"), and the "Guidance for Industry: Industry-Supported Scientific and Educational Activities" issued by the FDA (the "CME Guidelines"). See Pub.L. No. 105-115, 111 Stat. 2296; 62 Fed.Reg. 64,093 (1997).

On July 28, 1999, this Court concluded that the FDAMA and CME Guidelines were "contrary to the rights secured by the United States Constitution," specifically the First Amendment. Washington Legal Foundation v. Henney, 56 F.Supp.2d 81, 87 (D.D.C.1999) ("WLF III"). The government appealed. According to the Court of Appeals, the government's briefs were "quite confusing as to the meaning of the [FDAMA] and the CME Guidance." Washington Legal Found. v. Henney, 202 F.3d 331, 335 (D.C.Cir.2000) ("WLF IV"). The confusion however — as well as the controversy itself — abated at oral argument.

During oral argument, the government clarified its interpretation of the FDAMA and the CME Guidance. With respect to the FDAMA, the government explained that, although the FDAMA seeks to restrict the dissemination of information in certain ways, it does not grant the FDA authority to prosecute those who transgress the restrictions. Id. According to the government, the FDAMA creates a "safe harbor" for manufacturers who follow its provisions; i.e., manufacturers who disseminate information in accordance with the FDAMA will not be prosecuted under the FDA's misbranding authority using the information disseminated as evidence. Id. Of course, a misbranding suit might still continue and succeed using other forms of evidence, but as long as a manufacturer complies with the FDAMA provisions, it can be confident that the dissemination will not be held against it at a later date.

On the other side of the coin, drug manufacturers who disseminate information in ways contrary to the FDAMA take themselves out of the safe harbor, and open themselves up to the possibility that, if the FDA should bring a suit under its misbranding authority, the dissemination could be used against them. The key distinction to note in this situation, as well as in the previous one, is that the FDA's prosecutorial power flows from its long-established authority to prosecute manufacturers for misbranding, not from the newly created FDAMA. As the Court of Appeals summarized the government's position: "nothing in [the FDAMA] provides the FDA with independent authority to regulate manufacturer speech."

A similar interpretation applies to the CME Guidelines. The CME Guidelines order manufacturers to follow certain procedures in planning and promoting medical seminars. Although a manufacturer who violates these provisions might be prosecuted by the FDA, the prosecution will be pursuant to its misbranding enforcement power, and not some independent power created in the CME Guidelines. Id. at 335-36

With the revelation of the government's interpretation at oral argument, WLF admitted that it no longer had a constitutional objection to the FDAMA or CME Guidelines. Id. Seeing this, the Court of Appeals found there to be no case or controversy and declined to issue what would amount to an advisory opinion on the constitutionality of the FDAMA and CME Guidelines. Id. The Court then went a step further and vacated the district court's previous holdings and injunctions "insofar as they declared the FDAMA and the CME Guidelines unconstitutional." Id. at 337.

What brings the parties back to court is the FDA's March 16, 2000 Notice printed in the Federal Register. See 65 Fed.Reg. 14286 (Mar. 16, 2000). The Notice explains — from the FDA's perspective — the parameters of its regulatory authority in light of the Court of Appeals' opinion vacating this Court's July 28, 1999 injunction. According to the Notice, the FDA may, when appropriate, "proceed, in the context of case-by-case enforcement, to determine from a manufacturer's written materials and activities how it intends that its products be used." Id. A drug manufacturer's intent to promote an unapproved use, together with certain predicate acts, may in turn be used to make out a misbranding case. The WLF argues that such a practice is exactly what this Court prohibited in its July 16, 2000 injunction. Although the Court of Appeals vacated a portion of this injunction, WLF argues that the Court of Appeals expressly recognized that "part of [the] injunction still stands." WLF IV, 202 F.3d at 337.

ANALYSIS

I. The Nature of the Plaintiff's Claim

By the title of its motion, the plaintiff asks to the Court to "confirm and enforce [its] continuing injunction." Although this appears relatively straightforward, it is instructive to notice what the plaintiff is not claiming. The plaintiff is not claiming that the defendant's Notice violates the First Amendment, either facially or as applied. The plaintiff is also not claiming that the Notice is contrary to the FDA's official interpretation of the FDAMA and the CME Guidelines announced at the oral argument on appeal. Rather, the plaintiff is only claiming that the defendant's Notice is facially violative of the Court's July 28, 1999 injunction as modified by the Court of Appeals. Thus, to resolve this matter, the Court must analyze the exact scope of its injunction as well the exact nature of the FDA's Notice.

II. The Scope of the Modified Injunction

The proper place to start is with the text of the injunction as it was originally issued. On July 28, 1999, this Court ordered that the FDA

SHALL NOT in any way prohibit, restrict, sanction or otherwise seek to limit any pharmaceutical or medical device manufacturer or any other person:

a) from disseminating or redistributing to physicians or other medical professionals any article concerning prescription drugs or medical devices previous published in a bona fide peer-reviewed professional journal, regardless of whether such article includes a significant or exclusive focus on unapproved uses for drugs or medical devices that are approved by FDA for other uses and regardless of whether such article reports the original study on which FDA approval of the drug or device in question was based;

b) from disseminating or redistributing to physicians or other medical professionals any reference textbook (including any medical textbook or compendium) or any portion thereof published by a bona fide independent publisher and otherwise generally available for sale in bookstores or other distribution channels where similar books are normally available, regardless of whether such reference textbook or portion thereof includes a significant or exclusive focus on unapproved uses for drugs or medical devices that are approved by FDA for other uses;

c) from suggesting content or speakers to an independent program provider in connection with a continuing medical education seminar program or other symposium regardless of whether unapproved uses for drugs or medical devices that are approved by FDA for other uses are to be discussed.

WLF III, 56 F.Supp.2d at 88. The Court supplemented these orders with definitions for "bona fide peer-reviewed journal", "bona fide independent publisher", and "independent program provider." Id. The Court concluded the injunction by clarifying that

Nothing herein shall be construed to limit Defendants' application or enforcement of any rules, regulations, guidances, statutes or other provisions of law that sanction the dissemination or redistribution of any material that is false or misleading. In addition, Defendants may require any pharmaceutical or medical device manufacturer that sponsors or provides financial support for the dissemination or redistribution of articles or reference textbooks or for seminars that include references to unapproved uses for drugs or medical devices that are approved by FDA for other uses to disclose (i) its interest in such drugs or...