petition for the issuance, amendment, or repeal of a rule." The FDA regulation that grants this right is found at 21 C.F.R. § 10.30. The Complaint alleges that the FDA did not observe proper procedures as required by law with regard to the plaintiff's petitions. However, there is no allegation of a violation of a specific procedure, and the plaintiff stated at oral argument on January 13, 1995 that she does not seek relief based on a breach of required procedure by the FDA.
The relevant FDA regulation, 21 C.F.R. § 10.30, authorizes any person, whether that person is a U.S. citizen or not, to request the FDA Commissioner to "issue, amend, or revoke a regulation or order or take or refrain from taking any other form of administrative action." 21 C.F.R. § 10.30(a),(b) (1994). In responding to such a request, the Commissioner is to take into consideration available agency resources for the subject, the priority assigned to the petition and the overall work of the agency. 21 C.F.R. 10.30(e)(1) (1994).
Within 180 days of receipt of the petition, the Commissioner must respond by 1) approving the petition, 2) denying the petition, or 3) providing a tentative response indicating the reasons for postponing a final response (e.g., more time or more information is needed). While there is no requirement that the Commissioner hold hearings with regard to the petition, the Commissioner must consider the petition and must give written notice of the decision accompanied by an explanatory statement. See, e.g., National Organization for Reform of Marijuana Laws v. Ingersoll, 162 U.S. App. D.C. 67, 497 F.2d 654, 657-8 (D.C.Cir. 1974).
The Court notes that the plaintiff's petition was submitted on February 21, 1992. An FDA letter dated February 25, 1992, advises Ms. Henley that her petition was received, accepted and assigned docket number 92P-0088/CP1. An FDA letter setting forth the reasons for denying the petition is dated October 7, 1992. This letter is five pages long and discusses the plaintiff's application and the reasons supporting the FDA's decision to deny the petition. This letter was sent to Ms. Henley from Carl C. Peck, M.D., Director of the Center for Drug Evaluation and Research. The FDA explains that this is the branch of the agency responsible for reviewing and approving new drug applications and drug labeling.
The plaintiff submitted a petition for reconsideration on or about October 31, 1992. Petitions for reconsideration are governed by 21 C.F.R. § 10.33, which provides that these petitions are to be submitted within 30 days of the decision for which review is sought. Reconsideration is a two step process. First the Commissioner grants or denies reconsideration. Then, if reconsideration is granted, the Commissioner issues a written decision regarding the outcome of the review.
The Court notes that the plaintiff's petition for reconsideration was timely submitted. The reconsideration petition may be granted following a prompt review by the Commissioner, if it is in the public interest or in the interest of justice. The Commissioner must grant the petition upon a determination that the following factors are all present: 1) relevant information was not adequately considered; 2) the position is not frivolous; 3) sound public policy grounds support reconsideration; 4) public interests do not outweigh reconsideration. 21 C.F.R. 10.33(d) (1994). The Commissioner must issue a written decision that either reaffirms, modifies or overrules the prior decision, in whole or in part. 21 C.F.R. 10.33(f) & (i) (1994).
On or about September 30, 1993, a three page letter from Ronald G. Chesemore, Associate Commissioner for Regulatory Affairs was sent to Ms. Henley. This letter stated that the decision denying Ms. Henley's initial petition was affirmed and discussed the reasoning for this action.
The Court finds that the FDA did comply with the procedural requirements of APA § 553(e) and 21 C.F.R. §§ 10.30 & 10.33.
B. The standard of review
There is no allegation that the FDA's action was contrary to a constitutional right, power, privilege or immunity. See APA § 706(2)(B). Nor it is alleged that the FDA exceeded its jurisdiction or authority in denying Ms. Henley's petition so that it would be unlawful pursuant to APA § 706(2)(C).
In addition, the Court finds that the action before it is not one of the limited situations in which a trial de novo is warranted pursuant to § 706(2)(F). De novo review is appropriate only where 1) an adjudication by the agency is flawed by inadequate fact-finding procedures; and 2) issues not before the agency arise in a subsequent judicial proceeding. See Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402, 28 L. Ed. 2d 136, 91 S. Ct. 814 (1971). No adjudication is before the Court for review, therefore de novo review is not appropriate. APA § 553(2)(F). For the same reason, denial of a citizen petition is not to be scrutinized by a "substantial evidence" standard. Denial of a citizen petition is a final agency action subject to judicial review, but it is not an adjudication. APA § 553(2)(E).
It has been held that denial of petitions with regard to administrative agencies are subject to a "very narrow" and deferential scope of review. See, e.g., WWHT v. FCC, 656 F.2d 807, 816-818 (D.C.Cir. 1981). The reviewing court should "ensure the rationality and fairness of agency decisionmaking . . . ." Natural Resources Defense Council, Inc. v. S.E.C., 196 U.S. App. D.C. 124, 606 F.2d 1031, 1039 (D.C.Cir. 1979). "The agency's decision that the public interest does not require the promulgation of specific rules for the time being must be sustained 'if it violates no law, is blessed with an articulated justification that makes a rational connection between the facts found and the choice made, and follows upon a 'hard look' by the agency at the relevant issues.'" Id. at 817 (quoting Action for Children's Television v. FCC, 183 U.S. App. D.C. 437, 564 F.2d 458, 479 (D.C.Cir. 1977)).
"The court is not empowered to substitute its judgment for that of the agency." Citizens To Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 416, 28 L. Ed. 2d 136, 91 S. Ct. 814 (noting, additionally, that an agency decision is entitled to a presumption of regularity). The Supreme Court further discussed the "arbitrary and capricious" standard in Motor Vehicle Manufacturers, Ass'n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 77 L. Ed. 2d 443, 103 S. Ct. 2856 (1983) as follows:
The Department of Transportation accepts the applicability of the "arbitrary and capricious" standard. It argues that under this standard, a reviewing court may not set aside an agency rule that is rational, based on consideration of the relevant factors, and within the scope of the authority delegated to the agency by the statute. We do not disagree with this formulation. [footnote 9: The Department of Transportation suggests that the arbitrary-and-capricious standard requires no more than the minimum rationality a statute must bear in order to withstand analysis under the Due Process Clause. We do not view as equivalent the presumption of constitutionality afforded legislation drafted by Congress and the presumption of regularity afforded an agency in fulfilling its statutory mandate.] The scope of review under the "arbitrary and capricious" standard is narrow and a court is not to substitute its judgment for that of the agency. Nevertheless, the agency must examine the relevant data and articulate a satisfactory explanation for its action including a "rational connection between the facts found and the choice made." Burlington Truck Lines, Inc. v. United States, 371 U.S. 156, 168, 83 S. Ct. 239, 245-246, 9 L. Ed. 2d 207 (1962). In reviewing that explanation, we must "consider whether the decision was based on a consideration of the relevant factors and whether there has been clear error of judgment." Bowman Transportation, Inc. v. Arkansas-Best Freight System, Inc., supra, 419 U.S., at 285, 95 S. Ct., at 442; Citizens to Preserve Overton Park v. Volpe, supra, 401 U.S. at 416, 91 S. Ct. at 823. Normally an agency rule would be arbitrary and capricious if the agency has relied on factors which congress has not intended it to consider, entirely failed to consider an important aspect of the problem, offered an explanation for its decision that runs counter to the evidence before the agency, or is so implausible that it could not be ascribed to a difference in view or the product of agency expertise. The reviewing court should not attempt itself to make up for such deficiencies; we may not supply a reasoned basis for the agency's action that the agency itself has not given. SEC v. Chenery Corp., 332 U.S. 194, 196, 67 S. Ct. 1575, 1577, 91 L. Ed. 1995 (1947). We will, however, "uphold a decision of less than ideal clarity if the agency's path may reasonably be discerned." Bowman Transportation, Inc. v. Arkansas-Best Freight System, Inc., supra, 419 U.S., at 286, 95 S. Ct., at 442. See also Camp v. Pitts, 411 U.S. 138, 142-143, 93 S. Ct. 1241, 1244, 36 L. Ed. 2d 106 (1973) (per curium). . . . (emphasis supplied).
Id. at 42-43.
The Court will now review the FDA's action to determine if it was arbitrary or capricious, an abuse of discretion or unlawful under APA § 706(2)(a). In applying this standard, the Court is mindful that when it reviews agency action that is based upon scientific inquiry and technical expertise, a high degree of deference is appropriate. See Chevron v. Natural Resources Defense Council, 467 U.S. 837, 843-45, 81 L. Ed. 2d 694, 104 S. Ct. 2778 (1984) (courts should not direct an agency in choosing between reasonable alternatives); see also, Ewing v. N.L.R.B., 861 F.2d 353, 357 (2d Cir. 1988). Significantly, the 'arbitrary or capricious' standard to be applied here is "more lenient" than the "substantial evidence" standard applicable in reviewing adjudicative proceedings. See American Paper Institute, Inc. v. American Elec. Power Service Corp., 461 U.S. 402, 412 n.7, 76 L. Ed. 2d 22, 103 S. Ct. 1921 (1983).
The plaintiff argues that a deferential standard is not appropriate here because "the case involves issues of law, fact, common sense and common decency." She contends that women would want to know that studies of animals indicate that estrogen is a carcinogen, and states that review of this case "does not require review of complex scientific or technical data." The plaintiff states that two scientific facts support her petition and contends that they are "undisputed and totally supported by the record." These facts relate to the effects of estrogen in animals and the inconclusiveness of studies regarding the effects of estrogen in humans.
It is this Court's view that the FDA's determination of what labeling best reflects current scientific information regarding the risks and benefits of oral contraceptives involves a high degree of expert scientific analysis. However, as discussed above, the proper standard of review here is not de novo or whether the decision was supported by substantial evidence. The standard is whether the decision was arbitrary, capricious, an abuse or discretion or contrary to law.
C. FDA denial of the citizen petition
The FDA's explanatory statement that accompanies their October 7, 1992 denial of Ms. Henley's petition explains that a notice and comment procedure was conducted by the FDA in 1989 regarding the subject of her 1992 petition. The FDA explained that prior to 1989 the following warning was required to be set forth for oral contraceptives: estrogens have been shown to cause cancer in animals, which showing justifies the inference that estrogens may cause cancer in humans . . . ." (codified at 21 C.F.R. 310.501 (1989)). The FDA goes on to detail the revisions that were enacted as a result of the 1989 notice and comment proceeding. According to the FDA letter, the regulation was revised to reflect current information about the drug, with the intent to simplify the content and format of the information to reflect new information about the drug's benefits and risks in a more timely fashion."
The FDA letter sets forth its new guidance language for physician labeling, which is:
Numerous epidemiological studies have been performed on the incidence of breast, endometrial, ovarian, and cervical cancer incidence in women using oral contraceptives. The overwhelming evidence in the literature suggests that use of oral contraceptives is not associated with an increase in the risk of developing breast cancer, regardless of the age and parity of first use or with most of the marketed brands and doses. The Cancer and Steroid Hormone (CASH) study also showed no latent effect in the risk of breast cancer for at least a decade following long-term use. A few studies have shown a slightly increased relative risk of developing breast cancer, although the methodology of these studies, which included differences in examination of users and nonusers and differences in age at start of use has been questioned.