Excluding Documents that "Petition" the FDA.

Writing in the December issue of the newsletter of the Drug, Device and Biotech Committee, Kathryn M. Forgie-Evans of the Santa Monica office of Haight, Brown & Bonesteel discusses contacts between pharmaceutical, drug and medical device manufacturers and governmental agencies:

There has been a recent upsurge in newspapers and other publications of attacks on the accelerated approval process and other regulatory processes within the U.S. Food and Drug Administration. These articles have attacked the process and content of communications between the FDA and the involved pharmaceutical company. They also have discussed the "negotiations" occurring between those two entities that result not only in the approval of a particular drug, but also its indications, warnings and other information applicable to its eventual use.

First Amendment protection

Petitioning the government and its accompanying lobbying are protected by the First Amendment right "to petition the Government for a redress of grievances" and by the Noerr-Pennington doctrine, developed by Eastern Railroad Presidents Conference v. Noerr Motor Freight Inc., 365 U.S. 127 (1961), and United Mine Workers v. Pennington, 381 U.S. 657 (1965). This doctrine applies to petitioning activities directed at legislative, administrative or judicial branches of government. California Motor Transport Co. v. Trucking Unlimited, 404 U.S. 508, 510 (1972). Corporations as well as individuals, enjoy First Amendment rights. First National Bank of Boston v. Bellotti, 435 U.S. 765, 784 (1978).

While the Noerr-Pennington doctrine arose in the context of antitrust litigation, it has and should be applied to protect drug manufacturers who petition the FDA for approval of their drugs. Unfortunately, since this usually arises in the content of a motion in limine to exclude evidence of the manufacturer's contacts with governmental agencies, although there are numerous orders granting such motions, there is a distinct lack of published opinions concerning this subject. See, e.g., Bastoe v. Sterling Drug Inc., 683 F.Supp. 586 (S.D. Miss. 1989), and Burch v. Dow Chemical Co., No. 82564 (Super. Ct. of Butte Co., Cal., June 1, 1989).

Nevertheless, the reasoning behind the motions and orders...