See generally 21 U.S.C. § 321 et seq. 3 Second, the implementing regulations explicitly permit FDA to satisfy the requirement to respond within 180 days with a response that indicates why the agency has been unable to reach a decision on the petition. See 21 C.F.R. § 10.30(e)(2); see also Ctr. for Science in the Public Interest v. FDA, 74 F. Supp. 3d 295, 301 (D.D.C. 2014) (concluding that the “only applicable standard against which to measure” the timing of FDA’s response to a citizen petition is “the APA’s requirement that FDA act ‘within a reasonable time.’” and citing 5 U.S.C. § 555(b)); Hill Dermaceuticals, Inc. v. FDA, 524 F. Supp. 2d 5, 11 (D.D.C. 2007) (recognizing the sufficiency of a tentative response to a citizen petition). FDA’s “tentative response,” dated April 21, 2016, was sufficient to explain that FDA needed more time to engage with the complex issues raised in the Petition, and satisfied the requirement to respond to 3 Contrary to Plaintiff’s assertion, 21 U.S.C. § 371(e)(1) does not impose a statutory timeframe for Citizen Petition responses.

at 80. The regulatory timetable in 21 C.F.R. § 10.30(e)(2) for deciding the Biovail Citizen Petition is 180 days and is legally binding on FDA. FDA’s practice of delaying decisions on Citizen Petitions relating to the ANDA process and the use of excuses to avoid complying with its regulatory deadline are plainly unreasonable.

at 433. Because “Plaintiffs are essentially asking the [c]ourt to perform tasks traditionally Case 1:07-cv-08742-DLC Document 9 Filed 11/07/07 Page 31 of 45 Memorandum of Law in Support of Defendant’s Motion to Dismiss Page 23 relegated to the FDA,” the court denied the motion and directed plaintiffs, “should they wish, to file a ‘citizens’ petition’ with the FDA under 21 C.F.R. § 10.30.” Id.

at 433. Because “Plaintiffs are essentially asking the [c]ourt to perform tasks traditionally relegated to the FDA,” the court denied the motion and directed plaintiffs, “should they wish, to file a ‘citizens’ petition’ with the FDA under 21 C.F.R. § 10.30.” Id.

By contrast, plaintiff could have filed an NDA and would have benefitted from the more specific performance goal timeframes and processes applicable to that type of application.15 Moreover, plaintiff could have sought a formal determination of the agency’s views by filing a citizen petition under 21 C.F.R. § 10.30, which requires FDA to issue at least a tentative response within 180 days of such a petition, 21 C.F.R. § 10.30(e)(2), and its answer constitutes a final agency decision. 21 C.F.R. § 10.

Relator, however, need not have circumvented FDA’s enforcement authority and safeguards. Instead, she could have brought her concerns directly to FDA pursuant to long- established citizen petition procedures, 21 C.F.R. § 10.30, allowing concerned citizens to request FDA action. Through that mechanism, Relator could have requested “any . . . form of administrative action,” ranging from a review of Defendants’ adverse event reporting practices to “issu[ing] . . . an order” withdrawing approval for one or more of the subject drugs.

Relator, however, need not have circumvented FDA’s enforcement authority and safeguards. Instead, she could have brought her concerns directly to FDA pursuant to long- established citizen petition procedures, 21 C.F.R. § 10.30, allowing concerned citizens to request FDA action. Through that mechanism, Relator could have requested “any . . . form of administrative action,” ranging from a review of Defendants’ adverse event reporting practices to “issu[ing] . . . an order” withdrawing approval for one or more of the subject drugs.

. 286 21 C.F.R. 10.30 (emphasis added). 287 Cit.

(emphasis added). FDA fully complied with 21 C.F.R. § 10.30(e)(2) with regard to Biovail's citizen petition. FDA provided Biovail with a tentative response on June 7, 2006, within 180 days of FDA's receipt of the petition, explaining why FDA had been unable to reach a decision to date (i.e., because Biovail's petition "raises complex issues requiring extensive review and analysis by Agency officials").

That is all of the “process” to which Biovail is entitled under the governing FDA regulation. See 21 C.F.R. § 10.30(e)(ii)(3). Biovail has already availed itself of the opportunity to thoroughly express its views through the citizen petition process, and the FDA is currently reviewing Biovail’s petition consistent with the requirements of section 10.