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WASHINGTON LEGAL FOUNDATION v. FRIEDMAN

February 16, 1999

WASHINGTON LEGAL FOUNDATION, PLAINTIFF,
v.
MICHAEL FRIEDMAN, IN HIS OFFICIAL CAPACITY AS ACTING COMMISSIONER, FOOD AND DRUG ADMINISTRATION, 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 alter or amend the judgment and for a stay. Upon consideration of the motion, plaintiff's opposition thereto, defendants' reply, and the entire record in this case, the defendants' motion will be GRANTED in part and DENIED in part, and the parties will be directed to submit supplemental briefs as specified by the Court.

I. FACTS

On July 30, 1998, this Court granted plaintiff Washington Legal Foundation's (WLF) motion for summary judgment against the federal defendants Friedman and Shalala, representing the Food and Drug Administration and the Department of Health and Human Services, respectively. Having found that the defendants' policies violated the First Amendment to the United States Constitution, the Court entered judgment against the defendants and issued a permanent injunction barring them from "application or enforcement of any regulation, guidance, policy, order or other official action" that placed certain unconstitutional restrictions on the commercial speech of drug and device manufacturers. In particular, the Court stated that

  1.  Defendants 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 previously published in a bona
      fide peer-reviewed professional journal,
      regardless of whether such article includes a
      significant or exclusive focus on uses of
      drugs or medical devices other than those
      approved by FDA 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 uses of drugs or medical
      devices other than those approved by FDA; or
  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 uses of drugs and medical devices
      other than those approved by FDA are to be
      discussed.

Order Granting Summary Judgment and Permanent Injunction, Washington Legal Found. v. Friedman, 13 F. Supp.2d 51, 74-75 (D.D.C. 1998).

The first proposed amendment will be granted. The second proposed amendment, however, will be denied, and the parties will be directed to submit supplemental briefs on the extent to which the injunction may affect recently effective legislation and regulations.

II. DISCUSSION

The defendants contend that the July 30, 1998 order goes beyond the underlying Memorandum Opinion, and the issues presented in the litigation, in that it is not confined to the three Guidance Documents that were in effect at the time the order and injunction was issued. In particular, the defendants are concerned that the injunction might apply to Section 401 of the Food and Drug Administration Modernization Act (FDAMA) and its implementing regulations, both of which went into effect on November 21, 1998, after this Court's July 30, 1998 decision and injunction.

To begin with, the defendants are mistaken about the intended scope of the Court's opinion and injunction. The Court's Memorandum Opinion, while focusing on the concrete provisions of the Guidance Documents, was intended to apply to the policies underlying the Guidance Documents.*fn1 This was the position taken by the plaintiff ...


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