that the economic interest of the plaintiff provided an incentive for the plaintiff to advocate the "overriding necessity of ensuring public access to safe commercial drugs." Id.
Berlex's interests are aligned sufficiently with those of the intended beneficiaries of the PHSA. As a manufacturer of a similar product that was recently approved, Berlex has both the expertise and the incentive to monitor FDA's actions. Berlex's challenge, whatever its merits, has required the FDA to justify its acknowledged departure from past drug approval procedures and to explain its conclusions that reliance on clinical tests of a "comparable" product will not compromise the statutory requirement of "safety, purity, and potency." 42 U.S.C. § 262(d)(1). Berlex has standing to bring this claim under the PHSA.
b. FDA approval process
The PHSA authorizes FDA to license biological products that "meet standards designed to insure the continued safety, purity, and potency of such products . . . ." 42 U.S.C. § 262(d)(1). FDA's regulations require applicants for licenses to "submit data derived from nonclinical laboratory and clinical studies which demonstrate that the manufactured product meets prescribed standards of safety, purity, and potency . . . ." 21 C.F.R. § 601.2(a). No quantitative or measurable "standards" for safety, purity or potency exist. The regulations do, however, set out definitions of those terms that guide FDA's case-by-case determinations. 21 C.F.R. § 600.3.
Neither the PHSA itself nor FDA's regulations issued under the PHSA provide that the clinical study offered to demonstrate the safety, purity and potency of a new biological product shall have been conducted on that very product. The absence of a specific provision on this point raises the now-standard question of whether the agency's view of what is "appropriate in the context of this particular program is a reasonable one." Chevron, U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 845, 81 L. Ed. 2d 694, 104 S. Ct. 2778 (1984). FDA's policies and its interpretation of its own regulations will be paid special deference because of the breadth of Congress' delegation of authority to FDA and because of FDA's scientific expertise. Lyng v. Payne, 476 U.S. 926, 939, 90 L. Ed. 2d 921, 106 S. Ct. 2333 (1986); see Bristol-Myers Squibb Co. v. Shalala, 923 F. Supp. 212, 216 (D.D.C. 1996).
FDA's decision in this case to allow Biogen to rely on the clinical trials of BG9015 was based upon a reasonable interpretation of the PHSA and FDA regulations. FDA conceded that it had never before approved a new biological drug on the basis of a clinical study of a "comparable" drug, but FDA demonstrated by reference to public documents that the principle of comparability was not unknown and that, in fact, it had been previously applied in other situations. FDA argues that its extension of the comparability principle in this case reflects a reasonable interpretation of the statutory grant of its regulatory authority, particularly given the rapidly changing scientific and technological context in which FDA regulates biological products. The record contains ample support for FDA's comparability determination and for its finding that Avonex is "safe, pure and potent" as required by the statute. This court may not substitute its own judgment for that of the FDA, an agency created by Congress to address difficult scientific issues such as the one at the center of this claim.
3. Comparability Guidance Document
Berlex's third claim focuses on FDA's issuance, on April 25, 1996, of the "guidance document" that explained FDA's position on comparability. Berlex had predicted (accurately) that the guidance document would prove to be the harbinger of FDA's decision on May 17, 1996, to approve Biogen's license applications for Avonex.
Berlex's argument now is that the guidance document was unlawfully issued without the notice-and-comment rulemaking required by the APA.
The guidance document, which lays out FDA's policy for accepting clinical trials completed on "comparable" products, was published three weeks before FDA approved Avonex. The relationship between FDA's issuance of the guidance document and its approval of Avonex is not clear. FDA and Biogen both point out that the guidance document was not mentioned in the administrative record. FDA's explanation -- that "the agency applied the policy described in the comparability guidance" but "did not rely on the guidance in doing so" -- is murky. FDA's Opposition to Plaintiff's Motion for Summary Judgment, 7. For purposes of this analysis it will be assumed that (1) FDA attached considerable importance to the comparability guidance document and (2) the issuance of the guidance document and the approval of Avonex were in fact related events. Those assumptions make it necessary to address Biogen's claim that the guidance document was improperly issued.
The APA requires notice-and-comment rulemaking when an agency issues new "legislative" or "substantive" rules that establish binding norms having the force of law. 5 U.S.C. § 553; American Mining Congress v. Mine Safety & Health Admin., 302 U.S. App. D.C. 38, 995 F.2d 1106, 1109 (D.C. Cir. 1993). "Interpretive" rules, however, are expressly excused from the notice-and-comment requirements. 5 U.S.C. § 553(b)(3)(A). An interpretive rule is one "issued by an agency to advise the public of the agency's construction of the statutes and rules which it administers." Shalala v. Guernsey Memorial Hosp., 131 L. Ed. 2d 106, 115 S. Ct. 1232, 1239 (1995). In this circuit, a rule is legislative, rather than interpretive, if any one of the following four questions is answered in the affirmative:
(1) whether in the absence of the rule there would not be an adequate legislative basis for . . . agency action to confer benefits or ensure the performance of duties,