Court Opinion

ID: 9468942
Source: CourtListenerOpinion
Date Created: 2023-08-05 02:27:14.49616+00
Date Added: 2024-06-11T17:41:07.461094
License: Public Domain

EDWARDS, Circuit Judge,
dissenting:
Government officials in the present case are guilty of flagrant — and continuing— conduct in total disregard of applicable law. I am therefore constrained to add this note of dissent.
In this case, the Food and Drug Administration (FDA) indefinitely stayed, without notice and comment, the effective dates of regulations requiring that patient package inserts (PPIs) be provided for certain prescription drugs with potentially serious side effects. The PPIs would have provided patients with written instructions on the proper use of these drugs and information on the risks associated with their use. The agency’s indefinite stay of the regulations without notice and comment plainly violated the rulemaking requirements of the Administrative Procedure Act (APA), 5 U.S.C. § 553 (1976).
A brief review of the history of the regulations demonstrates the unlawfulness of the Government’s actions in this case. On September 12, 1980, the final PPI regulations were adopted by the FDA after approximately six years of careful study, including an extensive cost-benefit analysis. They are the product of a thorough rule-making process in which affected industries *520and professions, public interest groups and the general public participated. The final regulations, including a pilot program for applying the PPI requirements to ten specified prescription drugs, became effective on October 14, 1980. On November 25, 1980 and January 2, 1981, the FDA published final guidelines specifying the required text of the PPIs for five of the ten prescription drugs in the pilot program and set compliance dates of May 25,1981 for three of the drugs and July 1, 1981 for the other two.
On February 20, 1981, without informing the public, the FDA informally notified affected industries through the “trade press” that it was going to stay the effective dates of the regulations applying the PPI requirements to the first five drugs in the pilot program. Over two months passed before the new Secretary of Health and Human Services formally announced, on April 23, 1981, that these PPI requirements had been stayed pending a reexamination of the PPI program. It was not until April 28, 1981 that the FDA finally published a notice in the Federal Register announcing the stay. The record in this case reveals that, with the possible exception of a meeting with a representative of the pharmaceutical industry in early February, 1981, the Government has never solicited comment on its suspension of the PPI regulations.
The Government nonetheless argues that it was not required to provide notice and an opportunity for comment because the FDA’s action was merely a temporary “postponement” designed to maintain the status quo, not a “rule” subject to the rule-making requirements of the APA. Alternatively, the Government urges that there was “good cause” under 5 U.S.C. § 553(b)(B) for suspending the regulations without notice and comment. Both arguments are foreclosed by this court’s decision in Council of the Southern Mountains, Inc. v. Donovan, 653 F.2d 573, 580 n.28, 580-82 (D.C.Cir.1981) (per curiam). Certainly a decision to suspend indefinitely regulations that are the product of exhaustive study and comprehensive rulemaking, in order to allow wholesale reevaluation of a major regulatory program, cannot be viewed as a temporary measure for preserving the status quo. Indeed today, nine months after the first announcement of the stay, the Government proposes no specific action and gives no indication of when a decision on the unlawfully suspended regulations will be forthcoming. The advent of a new Administration cannot justify the Government’s complete and continued disregard of the APA’s rulemaking requirements.
In these circumstances, I believe that the case should not be held in abeyance for more than one week. The Government should be ordered to implement the suspended regulations or to give notice of, and an opportunity to comment on, any proposed changes in the regulations, including any change in their effective dates.