Court Dismisses Drug Manufacturer’s Suit Against FDA Challenging Bioequivalence Regulations For Lack of Standing

Apr 27, 2011   

On April 15, 2011, Judge Ellen Segal Huvelle of the United States District Court for the District of Columbia granted the FDAs motion to dismiss a lawsuit brought by ViroPharma, Inc. (“ViroPharma”) under the Administrative Procedure Act (“APA”) challenging the FDAs Abbreviated New Drug Application (“ANDA”) bioequivalent regulations. A copy of the Courts opinion can be read here.

The case centered on the various methods by which a generic drug manufacturer can establish the bioequivalence of its generic drug to an already FDA-approved brand name drug. Under 21 U.S.C. § 355 (j), prior to marketing a generic version of a brand name or “reference listed drug” (“RLD”), a generic drug manufacturer must submit an ANDA. Within the ANDA a generic drug manufacturer must demonstrate that the generic is the “bioequivalent” of the RLD, i.e. the new generic drug can be expected to have the same therapeutic effect as the RLD when administered to patients. There are two standard methods by which bioequivalence is determined, in vivo, (human testing) and in vitro, (laboratory testing). However, under 21 U.S.C. § 355(j)(8)(C), where a drug is not intended to be absorbed into the bloodstream, the FDA may establish “alternative, scientifically valid methods to show bioequivalence if the alternative methods are expected to detect a significant difference between the drug and the [RLD] in safety and therapeutic effect.”

The lawsuit stems from a citizen petition filed in 2007 by another brand name drug manufacturer, in which it petitioned the FDA to require all ANDAs for generics of its drug include in vivo bioequivalence studies. In response to that petition, the FDA asserted that, based on 21 U.S.C § 355(j)(8)(c) and 21 C.F.R. § 320.24, it had discretion to accept in vitro studies if those studies are determined to be scientifically valid methods of showing bioequivalence.

In its Complaint, ViroPharma, a drug manufacturer of the brand name drug Vancocin, alleged that 21 C.F.R § 320.21 established a general requirement that bioequivalence be demonstrated through in vivo testing unless the drug product meets the waiver criteria in 21 C.F.R. § 320.22. ViroPharma alleged that, by announcing that it had discretion to accept in vitro or in vivo testing, the FDA amended its regulations regarding bioequivalence by “interpreting the list of bioequivalence methods provided in 21 C.F.R. § 320.24 as a separate and sufficient basis for waiving in vivo bioequivalence requirements independent of 21 C.F.R. § 320.22.” As a result, ViroPharma alleged that the FDA violated the Administrative Procedure Act by effectively amending its ANDA regulations without engaging in notice and comment rulemaking.

In the Courts Opinion granting the FDAs motion, Judge Huvelle found that ViroPharmas lawsuit must be dismissed because ViroPharma lacked standing, a basic requirement to bringing a case. Put simply, standing is the right of a person to bring a case. In order to establish standing, a plaintiff must demonstrate: 1) that it has suffered an injury in fact, which is an actual or imminent invasion of a legally protected, concrete and particularized injury; 2) causation, i.e. the alleged injury must have been caused by the defendants conduct at issue; and 3) redressability, i.e. the court can provide a remedy to rectify the injury. Lujan v. Defenders of Wildlife, 504 U.S. 555, 560-561 (1992). Additionally, in the context of a procedural rule challenge, such as in this case, a plaintiff must “show not only that the defendants acts omitted some procedural requirement, [here a lack of notice and comment as required by the APA], but also that it is substantially probable that the procedural breach will cause the essential injury. . . .” Crt. For Law & Educ. V. Dept of Educ., 396 F.3d 1152, 1157 (D.C. Cir. 2005).

In this case, ViroPharma alleged that as a result of the FDA allowing in vitro bioequivalence studies to be submitted by generic drug manufacturers, it has or would in the future suffer two injuries: 1) future lost profits from generic competition and 2) current harm to its ongoing business operations. However, the Court rejected both of these arguments. The Court found that it was not substantially probable that the FDAs actions in declaring that it had the discretion to accept either in vivo or in vitro bioequivalence studies caused any injury in the form of lost profits. The Court reasoned that ViroPharma has not and will not suffer any injury to lost profits as a result of the FDAs announcement unless and until: 1) the FDA actually approves a ANDA for generic versions of Vancocin and 2) such approval must be based upon an in vitro bioequivalence study that does not qualify for a waiver under 21 C.F.R. § 320.22. However, until such time as the FDA actually relies upon the challenged interpretation of 21 C.F.R § 320.24, the Court ruled that ViroPharma has not suffered an injury.

The Court also found that ViroPharma could not establish standing based on current harms to its business. The Court found that the alleged harms were too vague and not sufficiently “concrete and particularized” to establish an injury in fact. Additionally, the Court went on to find that even if such harms could establish an injury in fact, ViroPharma failed to demonstrate a causal connection between these harms and the FDAs announcement because “ViroPharma elected to take [these actions] in response to its own predictions about what the FDA may do in the future. . . .” As a result, ViroPharma could not establish the causation element necessary for standing.

For more information regarding the ANDA generic drug approval process or for any questions regarding how your company can maintain FDA regulatory compliance, please contact us at contact@fidjlaw.com.