An administrative proceeding may be initiated in the following three ways:
(a) An interested person may petition the Commissioner to issue, amend, or revoke a regulation or order, or to take or refrain from taking any other form of administrative action. A petition must be either:
(1) In the form specified in other applicable FDA regulations, e.g., the form for a color additive petition in § 71.1, for a food additive petition in § 171.1 or § 571.1, for a new drug application in § 314.50, for a request to establish or amend an import tolerance in § 510.205, for a new animal drug application in § 514.1, or
(2) in the form for a citizen petition in § 10.30.
(b) The Commissioner may initiate a proceeding to issue, amend, or revoke a regulation or order or take or refrain from taking any other form of administrative action. FDA has primary jurisdiction to make the initial determination on issues within its statutory mandate, and will request a court to dismiss, or to hold in abeyance its determination of or refer to the agency for administrative determination, any issue which has not previously been determined by the agency or which, if it has previously been determined, the agency concluded should be reconsidered and subject to a new administrative determination. The Commissioner may utilize any of the procedures established in this part in reviewing and making a determination on any matter initiated under this paragraph.
(c) The Commissioner will institute a proceeding to determine whether to issue, amend, or revoke a regulation or order, or take or refrain from taking any other form of administrative action whenever any court, on its own initiative, holds in abeyance or refers any matter to the agency for an administrative determination and the Commissioner concludes that an administrative determination is feasible within agency priorities and resources.
[44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9034, Mar. 3, 1989; 86 FR 52409, Sept. 21, 2021]
Notes of Decisions
Ass'n of Am. Physicians & Surgeons, Inc. v. Food & Drug Admin., 539 F. Supp. 2d 4 (D.D.C. 2008).
· cites it 3× “Plaintiffs may file a citizen petition under 21 C.F.R. §§ 10.25 , 10.30. The Court therefore concludes that plaintiffs’ alleged informational injuries are inadequate to support constitutional standing here.”
Cerveny v. Aventis, Inc., 855 F.3d 1091 (10th Cir. 2017).
“’’ 21 C.F.R. § 10.25 (a). Accordingly, any citizen may ask the FDA to change or strengthen drug labels.”
In re Lipitor Antitrust Litig., 336 F. Supp. 3d 395 (D.N.J. 2018).
“" 21 C.F.R. §§ 10.25 , 10.30. Here, Defendants make a similar "but for" argument as discussed above in Wellbutrin and contend that before addressing the merits of the sham citizen petition claim, Plaintiffs must first prove that the challenged patent was invalid, because if it…”
Robert Perez v. Nidek Co., Ltd., 711 F.3d 1109 (9th Cir. 2013).
“The FDA is responsible for investigating potential violations of the FDCA, and the Act provides the agency with a range of enforcement mechanisms, such as injunction proceedings, civil and criminal penalties, and seizure.”
PhotoMedex, Inc. v. Irwin, 601 F.3d 919 (9th Cir. 2010).
“21 C.F.R. §§ 10.25 (a), 10.30. Section 337(a) of the FDCA bars private enforcement of the statute, stating that “all such proceedings for the enforcement, or to restrain violations, of this[Act] shall be by and in the name of the United States.”
Otsuka Pharm. Co. v. Burwell, 302 F. Supp. 3d 375 (D.C. Cir. 2016).
“On February 29, 2016, Defendants filed a notice informing the Court that the three-year exclusivity period afforded to Abilify Maintena under romanette iii had expired the previous day (on February 28, 2016). ( See Notice, ECF No. 36.”
— 21 C.F.R. § 10.25(a) — 1 case
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