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11/30/81 Public Citizen, National v. Department of Health and

November 30, 1981

PUBLIC CITIZEN, NATIONAL WOMEN'S HEALTH NETWORK, ET AL., APPELLANTS

v.

DEPARTMENT OF HEALTH AND HUMAN SERVICES, ET AL. APPEAL FROM THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA (D.C. CIVIL ACTION NO. 81-00820). 1981.CDC.303



Before MacKINNON, ROBB and EDWARDS, Circuit Judges.

UNITED STATES COURT OF APPEALS, DISTRICT OF COLUMBIA CIRCUIT

APPELLATE PANEL:

Dissenting opinion filed by Circuit Judge HARRY T. EDWARDS.

PER CURIAM DECISION

This cause came on to be heard on the record on appeal from the United States District Court for the District of Columbia and was argued by counsel.

On September 12, 1980, after a six-year period of meetings and research, the Food and Drug Administration published final regulations requiring "patient package inserts" ("inserts") to be given out with ten widely used drugs, which are distributed only to patients on prescriptions by doctors. 45 Fed.Reg. 60754 (Sept. 12, 1980). The FDA has previously required inserts for five drugs and devices, and its authority to do so for estrogens has been upheld under the Food, Drug, and Cosmetic Act §§ 201, 502(a), 503(b)(2), 21 U.S.C.A. §§ 321, 352(a), 353(b)(2) (West 1972 & Cum. Supp. 1981). Pharmaceutical Manufacturers Association v. FDA, 634 F.2d 106 (3d Cir. 1980) (per curiam).

The regulation published on September 12 was not self-executing but provided that each specified drug would be required to be dispensed with inserts 180 days after a notice for that drug was published in the Federal Register. In the lame-duck period of the Carter administration the FDA published notices requiring "inserts" for five drugs. 45 Fed.Reg. 78514 (Nov. 25, 1980), and 46 Fed.Reg. 28, 160 (Jan. 2, 1981).

On February 20, 1981, the FDA announced to the "trade press" that it intended to stay implementation of the insert program, in particular the actual distribution of inserts for the five previously specified drugs. Secretary Schweiker issued a press release on April 23, and a notice appeared in the Federal Register on April 28, 46 Fed.Reg. 23739 (Apr. 28, 1981), formally stating that implementation of the program would be stayed. The Federal Register notice stated:

Important questions continued to be raised regarding the cost, necessity, and utility of the FDA's patient package insert program. These questions merit further review before final implementation of any requirements. FDA also believes additional review of these requirements to be consistent with the spirit of the provisions of Executive Order 12291 (46 FR 13193, February 19, 1981).

The notice gave no explanation for the agency's failure to give notice to and solicit comments from the public, and it did not state any expiration date for the stay.

The instant suit was filed on April 8, 1981, alleging that such a stay is arbitrary and capricious, contrary to law, allegedly based on ex parte contracts, and not undertaken in compliance with the Administrative Procedure Act, 5 U.S.C. § 553 (1976). Cross-motions for summary judgment were filed with the District Court, which, without hearing argument, granted summary judgment for defendants on July 31, 1981. This appeal followed.

On the entire record and proceedings herein it is hereby,

ORDERED and ADJUDGED, that the Secretary of the Department of Health and Human Services is hereby allowed until December 24, 1981, to determine whether to take no further action, or to proceed by notice and comment, or a hearing, or without notice and comment or hearing to revoke or revise the stay ...


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