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WASHINGTON LEGAL FOUNDATION v. HENNEY

July 28, 1999

WASHINGTON LEGAL FOUNDATION, PLAINTIFF,
v.
JANE E. HENNEY, IN HER OFFICIAL CAPACITY AS COMMISSIONER, FOOD AND DRUG ADMINISTRATION,[FN1] AND DONNA SHALALA, IN HER OFFICIAL CAPACITY AS SECRETARY, DEPARTMENT OF HEALTH AND HUMAN SERVICES, DEFENDANTS.



The opinion of the court was delivered by: Lamberth, District Judge.

MEMORANDUM OPINION

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;*fn2 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.*fn3

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 However, as the Court anticipated in its July 30, 1998 decision, the Guidance Documents were superseded on November 21, 1998 by the Food and Drug Administration Modernization Act (and implementing regulations issued by the FDA).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.

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 FDAMA*f ...


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