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

• Decision Date: 28 July 1999
• Docket Number: No. Civ.A. 94-1306 (RCL).,Civ.A. 94-1306 (RCL).
• Citation: 56 F.Supp.2d 81
• Court: U.S. District Court — District of Columbia
• Parties: WASHINGTON LEGAL FOUNDATION, Plaintiff, v. Jane E. HENNEY, in her official capacity as Commissioner, Food and Drug Administration,<SMALL><SUP>1</SUP></SMALL> and Donna Shalala, in her official capacity as Secretary, Department of Health and Human Services, Defendants.

56 F.Supp.2d 81

WASHINGTON LEGAL FOUNDATION, Plaintiff, v. Jane E. HENNEY, in her official capacity as Commissioner, Food and Drug Administration,¹ and Donna Shalala, in her official capacity as Secretary, Department of Health and Human Services, Defendants.

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

United States District Court, District of Columbia.

July 28, 1999.

Richard A. Samp, Washington Legal Foundation, Washington, DC, Thomas William Queen, Wiley, Rein & Fielding, Washington, DC, for plaintiff.

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

MEMORANDUM OPINION

LAMBERTH, District Judge.

This matter comes before the Court on defendants' motion to amend the Court's July 30, 1998 Order Granting Summary Judgment and Permanent Injunction. On February 16, 1999, the Court granted defendants' motion in part and denied it in part;² the Court also requested that the parties submit supplemental briefs addressing "the issues raised by the recently effective FDAMA [Food and Drug Administration Modernization Act] and its implementing regulations," in light of this Court's July 30, 1998 ruling striking down several FDA policies as unconstitutional. Upon consideration of the plaintiff's and defendants' supplemental briefs, the record in this case, and the applicable law, the Court will deny the defendant's motion to amend insofar as it seeks to exclude the FDAMA from the scope of the July 30, 1998 order, and amend the order to reflect the unconstitutionality of the FDAMA and its implementing regulations.

I. BACKGROUND

The facts of this case are set forth in detail in the Court's July 30, 1998 memorandum opinion. See WLF v. Friedman, 13 F.Supp.2d 51 (D.D.C.1998). In that decision, the Court granted summary judgment against the defendants, holding that the FDA was violating the First Amendment rights of plaintiff's members by unduly limiting the manner in which drug manufacturers may disseminate information relating to unapproved — or "off-label" — uses of FDA-approved drugs.³

At the time of this Court's July 30, 1998 decision, the FDA's unconstitutional policies were embodied in three Guidance Documents regulating the dissemination of journal articles and reference texts and manufacturer support of continuing medical education (CME) activities. However, as the Court anticipated in its July 30, 1998 decision, the Guidance Documents were superseded on November 21, 1998 by the Food and Drug Administration Modernization Act (and implementing regulations issued by the FDA). The provisions of the FDAMA perpetuate in part and modify in part the policies contained in the Guidance Documents. In particular, the FDAMA permits a drug manufacturer to disseminate journal articles and reference texts only under certain conditions, including the following:

1. The drug must be the subject of an approved application or otherwise lawfully marketed.

2. The disseminated information must be unabridged, not false or misleading, and not pose a significant risk to the public health.

3. The information must not be derived from clinical research by another manufacturer without that manufacturer's permission.

4. The manufacturer must submit an advance copy of the information to be disseminated to FDA along with any clinical trial information and reports of clinical experience.

5. The manufacturer must submit a supplemental new drug application for the off-label use or have certified that such an application will be submitted within the applicable statutory deadline, unless the Secretary determines that the manufacturer is exempt from this requirement because a) such supplemental application would be prohibitively expensive or b) it would be unethical to conduct the necessary studies.

6. The disseminated information must include a prominent disclosure that a) the material concerns an off-label use not approved by the FDA; b) the material is disseminated at the manufacturer's expense; c) identifies the authors of the information that have received compensation from or have financial interests in the manufacturer; d) includes the product's current approved labeling; e) includes a statement that there exist products approved for the particular intended use (if applicable); f) identifies the person providing funding for a study of the off-label use; and g) gives a bibliography of other scientific articles concerning the off-label use.

7. The manufacturer must prepare and submit semi-annually to the FDA lists of the articles and reference publications disseminated and the categories of recipients.

See Defs.' Suppl.Memo. at 7-8; 21 U.S.C. § 360aaa. The plaintiff objects to most of these requirements (most forcefully to the last four) as unconstitutional and inconsistent with this Court's July 30, 1998 order and injunction. Defendants contend that, to the extent the FDAMA is inconsistent with the July 1998 order, the Court should amend that order to exclude from its scope the FDAMA and its implementing regulations.

On February 16, 1999, this Court denied defendants' motion to amend the judgment insofar as it sought to limit the applicability of the July 30, 1998 order solely to the Guidance Documents in effect at the time the order was issued, rather than to the underlying policies contained in those documents. See 36 F.Supp.2d at 19. That decision squarely raised for the Court's consideration the issue of the FDAMA's validity in light of the July 30, 1998 judgment and injunction. Preferring to address that issue with due deliberation after hearing from both sides, the Court requested supplemental briefs from the parties specifically addressing the FDAMA and its implementing regulations. Based on that briefing, the Court now holds that the FDAMA largely perpetuates the policies held unconstitutional by the Court on July 30, 1998 and therefore may not be applied or enforced by FDA. Defendant's motion to amend the Order Granting Summary Judgment and Permanent Injunction will be denied in relevant part, although the Court will amend the order sua sponte to reflect the Court's determination that the FDAMA and its implementing regulations are unconstitutional.

II. DISCUSSION

As an initial matter, it may be helpful more clearly state the issue before the Court today. Read in the most narrow sense, defendants' motion could be viewed as simply a Rule 60 motion to amend the language of the July 30, 1998 order to exclude the FDAMA from the scope of the permanent injunction. From this perspective, the issue before the Court would be simply the extent to which the provisions of the FDAMA are covered by the injunction and, if covered, whether the injunction should be amended to exclude them. This articulation of the issue is, however, unduly narrow.

As reiterated in this Court's decision of February 16, 1999, the principal issue in this case has always been whether the FDA has unconstitutionally burdened plaintiff's First Amendment rights. The FDAMA and its implementing regulations have altered, to some extent, the FDA's policies regarding the dissemination of articles and texts relating to off-label uses. The true issue in controversy on the present motion, therefore, is whether the changes in FDA policy effected by the FDAMA have brought the FDA into compliance with the First Amendment. In other words, is the FDA unconstitutionally burdening free speech today? This question requires that the Court consider the defendants' motion as one for reconsideration in light of recent changes in the controlling law.

Upon review, the Court is persuaded that the decisions of July 30, 1998 and February 16, 1999 did and do correctly state the law applicable to this case, and the Court incorporates its prior review of the caselaw without repeating it here. The question before the Court, therefore, is whether the FDA's policies as currently embodied in the FDAMA⁴ are unconstitutional under the legal standard stated by the Court in those decisions.

A. The Central Hudson Test Applies

As in its previous decision of July 30, 1998, the Court will analyze the constitutionality of the FDA's policies (as now contained in the FDAMA) under the four-prong inquiry articulated by the Supreme Court in Central Hudson Gas & Electric Corp. v. Public Service Commission of New York, 447 U.S. 557, 100 S.Ct. 2343, 65 L.Ed.2d 341 (1980), for judicial review of commercial speech regulations. Under Central Hudson, the court looks first to determine whether the speech at issue is false or inherently misleading. If the speech is truthful and nonmisleading, the government must demonstrate a substantial interest that is directly advanced by the regulation without burdening substantially more speech than necessary. See id.

Before applying the Central Hudson analysis, however, one preliminary issue should be disposed of. Defendants make the argument in their supplemental briefs that the Court should not apply First Amendment commercial speech scrutiny to the FDAMA because, in defendants' words, the act "affirmatively permits" speech so long as it complies with the requirements of the statute. This is, of course, preposterous. The First Amendment is premised upon the idea that people do not need the government's permission to engage in truthful, nonmisleading speech about lawful activity. To give an extreme and obvious example, the government could not justify a law criminalizing criticism of the government on the theory that such a law would "affirmatively permit" pro-government speech. Neither can the FDA escape judicial review of its speech restrictions on the theory that they "permit" speech that complies with the FDA's wishes.⁵

That said, the Court will turn to its Central Hudson analysis.

B. The Speech is Neither Unlawful Nor Inherently Misleading

First, the Court reiterates its prior holding that the speech at issue here is neither false nor inherently misleading. See 13 F.Supp.2d at 66-67. It is a difficult contention indeed that the medical and...