The opinion of the court was delivered by: 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;*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.
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superseded on November 21, 1998 by the Food and Drug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.
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 ...