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

• Decision Date: 16 February 1999
• Docket Number: No. Civ.A. 94-1306 (RCL).,Civ.A. 94-1306 (RCL).
• Citation: 36 F.Supp.2d 16
• Parties: 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.
• Court: U.S. District Court — District of Columbia

36 F.Supp.2d 16

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.

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

United States District Court, District of Columbia.

February 16, 1999.

Richard A. Samp, Washington Legal Foundation, Washington, DC, Thomas William Queen, Bertram Walter Rein, Daniel E. Troy, 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 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).

On August 13, 1998, defendants filed a Rule 59(e) motion to alter or amend the judgment and for a stay, which is now before the Court. In their motion, the defendants request that the Court amend the July 30, 1998 order and injunction in two ways: (1) to clarify that the injunction applies only to unapproved uses of drugs or devices approved by the FDA for some other use, not to drugs or devices that have not received FDA approval for any use; and (2) to restrict the scope of the order to the three Guidance Documents discussed in the Court's opinion. In response to the motion to alter or amend, the plaintiff has consented to the first proposed amendment clarifying that the order and injunction applies to unapproved uses of approved drugs, but the plaintiff opposes the second amendment.

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.¹ This was the position taken by the plaintiff in its complaint, and it was the understanding of the Court throughout the litigation.

The Court's decision and injunction must be read to apply to the underlying policies of the FDA, and not merely to the express provisions of the Guidance Documents, given the history of the policies at issue, which have been expressed in various documents over the years. Before the 1980's, the FDA did not attempt to regulate the dissemination by drug and device manufacturers of scientific and medical information concerning unapproved uses of FDA-approved drugs.² In the 1980's, however, drug manufacturers began to devote increasingly large resources to sponsoring continuing medical education (CME) courses, especially when those courses concerned off-label uses of their drugs. Concerns about this sponsorship as a promotional practice led to Congressional hearings in 1990. In response, the FDA developed a Draft Concept Paper attempting to set forth the circumstances under which a manufacturer could properly sponsor scientific and educational programs that addressed off-label uses, but this paper only heightened the confusion surrounding the issue. In 1992, the...