Public Citizen Health Research Group v. Commissioner, Food & Drug Admin., 83-1302

• Decision Date: 27 July 1984
• Docket Number: No. 83-1302,83-1302
• Citation: 740 F.2d 21
• Parties: PUBLIC CITIZEN HEALTH RESEARCH GROUP, et al., Appellants, v. COMMISSIONER, FOOD & DRUG ADMINISTRATION, and Aspirin Foundation of America, Inc.
• Court: U.S. Court of Appeals — District of Columbia Circuit

Page 21

740 F.2d 21

238 U.S.App.D.C. 271

PUBLIC CITIZEN HEALTH RESEARCH GROUP, et al., Appellants, v. COMMISSIONER, FOOD & DRUG ADMINISTRATION, and Aspirin Foundation of America, Inc.

No. 83-1302.

United States Court of Appeals District of Columbia Circuit.

Argued Dec. 7, 1983.

Decided July 27, 1984.

Appeal from the United States District Court for the District of Columbia (D.C. Civil Action No. 82-01346).

Katherine A. Meyer, Washington, D.C., with whom William B. Schultz and Alan B. Morrison, Washington, D.C., were on the brief, for appellants.

Gerald C. Kell, Atty. Dept. of Justice, Washington, D.C., with whom J. Paul McGrath, Asst. Atty. Gen., J. Patrick Glynn and Margaret A. Cotter, Attys., Dept. of Justice, Washington, D.C., and Thomas Scarlett, Chief Counsel, Washington, D.C., and Forrest T. Patterson and Ann H. Wion, Associate Chief Counsel, Food & Drug Administration, Rockville, Md., were on the brief, for appellee Commissioner, Food & Drug Administration. Stanley S. Harris, U.S. Atty., Washington, D.C., at the time the brief was filed, and Craig R. Lawrence and Patricia J. Kenney, Asst. U.S. Attys., Washington, D.C., entered appearances for appellee Commissioner, Food & Drug Admin.

R. Bruce Dickson, Washington, D.C., with whom Donald L. Morgan, Washington, D.C., was on the brief, for appellee Aspirin Foundation of America, Inc. Michael A. Wiegard, Washington, D.C., entered an appearance for appellee Aspirin Foundation of America, Inc.

Ronald F. Kehoe, Boston, Mass., of the bar of the Supreme Judicial Court of Massachusetts, pro hac vice, by special leave of court, with whom Henry T. Goldman and Michael X. Morrell, Washington, D.C., were on the brief, for amicus curiae Committee on the Care of Children, urging affirmance.

Before WRIGHT and TAMM, Circuit Judges, and SWYGERT, ^* Senior Circuit Judge.

Opinion for the court filed by Circuit Judge J. SKELLY WRIGHT.

J. SKELLY WRIGHT, Circuit Judge:

In this case we must decide whether the failure to date of the Food and Drug Administration ¹ to promulgate a rule requiring certain warnings on labels of aspirin products violates the prohibition of "unreasonably delayed" agency action in the Administrative Procedure Act. 5 U.S.C. Sec. 706(1) (1982) ("[t]he reviewing court shall * * * compel agency action unlawfully withheld or unreasonably delayed"). Based on considerable scientific evidence suggesting that children with influenza or chicken pox who take aspirin face a greatly increased risk of developing Reye's Syndrome, a rare but often fatal disease, appellant Public Citizen Health Research Group (HRG) and others seek a court order mandating appropriate warning labels on aspirin products.

The "misbranding" provision of the Food, Drug and Cosmetic Act (FDCA), 21 U.S.C. Sec. 301 et seq. (1982), requires drug labels to bear "such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health * * *." 21 U.S.C. Sec. 352(f)(2). Claiming that this statutory norm requires aspirin products to bear a label warning of the risk of Reye's Syndrome, HRG first petitioned FDA to promulgate a regulation ordering such labeling immediately. Initially FDA responded favorably and took preliminary steps toward issuance of such a rule, but the agency turned back midstream and decided that further study was needed before such a rule should be promulgated. As of this time FDA is still investigating the issue. Dissatisfied with the pace of FDA's decision-making, HRG brought suit in the District Court seeking an injunction ordering FDA to promulgate a rule requiring labeling. On cross-motions for summary judgment, the District Court invoked the ripeness and finality doctrines and declined to order FDA to promulgate such a rule at this stage. Because we find that a judicial resolution of the substantive issues that HRG's request presents is inappropriate at this stage in the administrative process, we affirm the District Court's decision to refrain from adjudicating the labeling question. The paramount public health concerns that this case raises compel us, however, to remand to the District Court for a determination whether FDA has "unreasonably delayed" resolution of the labeling question, see 5 U.S.C. Sec. 706(1), and if so to order FDA to commence rulemaking on the labeling issue immediately and to reach a decision as expeditiously as is possible consistent with sound decision-making.

I. BACKGROUND

A. The Link Between Aspirin and Reye's Syndrome

Reye's Syndrome is a rare but deadly childhood disease that afflicts between 600 and 1,200 young people each year in this country. See Advance Notice of Proposed Rulemaking, Labeling for Salicylate-Containing Drug Products, 47 Fed.Reg. 57886 (December 28, 1982), Joint Appendix (JA) 449. The disease usually affects children recovering from viral infections such as influenza or chicken pox. Initial symptoms include severe vomiting, irritability, and lethargy, and the disease rapidly progresses in many cases to convulsions and coma. Death occurs in 20 to 30 percent of all cases, and permanent brain damage occurs in many others. Id.

Though the exact cause of Reye's Syndrome is unknown, the rapid onset of the disease in children recovering from influenza or chicken pox has prompted some scientists to suggest that a toxic agent interacting with the viral infection might be a causative factor in the disease. Many people in the medical community have for at least 20 years suspected that this causative agent might be salicylates--a class of chemicals that includes aspirin. Several early studies suggested that children with influenza or chicken pox who are treated with aspirin have an increased risk of developing Reye's Syndrome. See id. at 57886-57887, JA 449-450 (summarizing early studies).

This mounting evidence led the Center for Disease Control (CDC), an agency within the Department of Health and Human Services, to cooperate with the state health departments of Arizona, Ohio, and Michigan in conducting four case-control ² studies to investigate possible association between salicylates and the onset of Reye's Syndrome. All four studies documented that children with Reye's Syndrome were significantly more likely to have taken aspirin during antecedent illnesses than were children in the control group who had had the same illnesses. See id. at 57887-57896, JA 450-459. After reviewing the data in three of the four state studies (Arizona, Ohio, and the first of two Michigan studies), CDC published on November 7, 1980 the following conclusion: "The results of these studies suggest that during certain viral illnesses the use of salicylates * * * may be a factor in the pathogenesis of Reye syndrome." CDC Morbidity and Mortality Weekly Report (November 7, 1980) at 539, JA 10. CDC went on to recommend that "parents should be advised to use caution when administering salicylates to treat children with viral illnesses * * *." Id.

At this time CDC also convened a "working group" of outside scientific consultants to evaluate the four state studies. After a year of study the CDC-sponsored working group concluded that "there is strong epidemiologic evidence for an association between the occurrence of Reye's syndrome and the prior ingestion of salicylate containing medication." Report of Reye's Syndrome Working Group (November 12, 1981) at 1, JA 12. Though noting possible methodological flaws in the studies, the working group found it "unlikely that these limitations * * * could totally explain the strength of the association or the consistency of the observation in the various studies." Id. Based on this evaluation,

[i]t was the consensus of the working group that until the nature of the association between salicylates and Reye's syndrome is clarified, the use of salicylates should be avoided, when possible, for children with varicella infections [chicken pox] and during presumed influenza outbreaks. * * *

Id. at 3, JA 14.

B. HRG's Petition for FDA Action

In light of this evidence, and consequent calls from CDC for warnings about the association between aspirin and Reye's Syndrome, appellant Public Citizen Health Research Group, a nonprofit public interest group that, inter alia, seeks to identify health risks in over-the-counter drugs, petitioned the Food and Drug Administration to require a warning label on aspirin-containing products. On February 10, 1982 Dr. Sidney M. Wolfe of HRG orally asked the Deputy Commissioner of FDA to require a label warning of the association between salicylates and Reye's Syndrome. See Affidavit of Sidney M. Wolfe, M.D. (July 15, 1982), JA 163-164. By letter dated March 9, 1982 HRG formally petitioned FDA "to immediately change the labelling on all aspirin-containing products to warn against use by children with chicken pox or during the winter because of the link between aspirin and Reye's Syndrome." Letter of Sidney M. Wolfe, M.D. to Mark Novitch, M.D., Associate Commissioner of FDA (March 9, 1982), JA 33. Filing of a citizen's petition is authorized by 21 C.F.R. Sec. 10.30 (1983).

By letter dated April 8, 1982 HRG supplemented its March 9th petition by outlining the legal basis for its claim that FDA must act immediately to require a warning label on products containing aspirin. HRG based its demand primarily on Section 331 of FDCA, 21 U.S.C. Sec. 331, which prohibits the sale in interstate commerce of any "misbranded" drug. A drug is "misbranded" if its labeling is "misleading in any particular" or "unless its labeling bears * * * such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health * * *." Id. Sec. 352(a) & (f)(2). According to appellant HRG, the evidence linking aspirin to Reye's Syndrome made clear that aspirin was "misbranded" within the meaning of Section 352 and a warning label was therefore required. See Letter from Sidney M. Wolfe et al. to Arthur Hull Hayes, M.D. (...