Section 10.30 - Citizen petition

35 Analyses of this regulation by attorneys

  1. Unpacking Averages: FDA’s Extraordinary Delay in Resolving Citizen Petitions

    Epstein Becker & GreenBradley Merrill ThompsonOctober 3, 2023

    y wanted to treat it as a trade complaint. Closed also includes some cases where the agency deemed the request to be one for an advisory opinion, and they gave an advisory opinion in the response, and then deemed the matter closed. Thus, the agency didn’t really accept or reject the petition on policy grounds but simply explained whatever the petitioner had asked to be explained. Another subcategory here was when the petitioner died. I told you I wasn’t kidding about dying before the petitioner hears. Intuitively, the issue lingers on after the death of the petitioner, but FDA seizes on the person's death as an excuse to close the matter.“Denied” is hopefully self-explanatory-- the agency rejected whatever the petition requested.“Dismissed as moot” was used when FDA concluded that either the relevant facts or law had changed since the petition was filed and there was no longer any reason to consider the petition. This category is expressly provided for in the regulations, specifically 21 CFR 10.30(e)((2)(iii) which says the Commissioner can dismiss a petition “if at any time the Commissioner determines that changes in the law, facts or circumstances since the date on which the petition was submitted have rendered the petition moot.”“Granted” is also probably self-explanatory, but I should add here that I included as granted any petition that was granted even just in part. There were several petitions where the FDA granted them in part and denied them in part, but I chose to characterize even a partial win as a win.“Other” just include some odd ducks that are procedurally unique.“Withdrawn” is probably intuitive, but the circumstances may not be. This is when the petitioner decided to withdraw the petition. However, I found what might have happen behind the scenes interesting. At least one petitioner wrote that since the FDA told him that there was no way the petitioner was going to succeed, the petitioner very grudgingly withdrew the petition. It seems at least in some cases, FDA

  2. The Coming 505(q) Citizen Petition Cliff and Some Interesting Petition Strategies

    Hyman, Phelps & McNamara, P.C.Kurt R. KarstSeptember 4, 2012

    By Kurt R. Karst – As we patiently await FDA’s next annual report to Congress on 505(q) citizen petitions (see our previous posts on FDA’s annual reports here, here, and here) we thought we would take a minute to share with our readers some observations on the recent changes to the law and some interesting strategies we have heard about.FDC Act § 505(q), which was added to the law with the enactment of the 2007 FDA Amendments Act, provides that FDA shall not delay approval of a pending application as a result of a citizen petition submitted to the Agency pursuant to 21 C.F.R. § 10.30 (citizen petition) or § 10.35 (petition for stay of action), unless FDA “determines, upon reviewing the petition, that a delay is necessary to protect the public health.” Until July 9, 2012, FDC Act § 505(q) applied in the context of a pending ANDA or 505(b)(2) application and stated that “[FDA] shall take final agency action on a petition not later than 180 days after the date on which the petition is submitted.”

  3. Amarin Case Demonstrates Limits of ITC Jurisdiction

    Ropes & Gray LLPMatthew J. RizzoloNovember 30, 2017

    In the past, the Federal Circuit has exercised jurisdiction over an appeal from a decision by the ITC where that decision had equivalent effect of a final determination on the merits.6 Yet it’s possible Amarin may seek a writ of mandamus from the Federal Circuit, arguing that the commission’s decision not to institute the investigation was arbitrary and capricious in violation of the APA,7 especially given Section 337’s mandate that the commission shall investigate any properly pled Section 337 complaints.In the non-ITC context, Amarin could also file a citizen petition pursuant to 21 C.F.R. § 10.30, and request that the FDA issue a new regulation classifying the accused omega-3 products as “new drugs.” Doing so would allow Amarin to present all of its arguments that it made before the commission to the FDA instead.

  4. FDA Issues Draft Guidance Document Interpreting FDC Act § 505(q) - "Petitions and Civil Actions Regarding Approval of Certain Applications"

    Hyman, Phelps & McNamara, P.C.Kurt R. KarstJanuary 20, 2009

    The most recent version of our "FDC Act § 505(q) Citizen Petition Tracker," which tracks such petitions, is now available (and is updated on a regular basis).Briefly, FDC Act § 505(q) provides that FDA shall not delay approval of a pending ANDA or 505(b)(2) application as a result of a citizen petition submitted to the Agency pursuant to 21 C.F.R. § 10.30 (citizen petition) or § 10.35 (petition for stay of action), unless FDA "determines, upon reviewing the petition, that a delay is necessary to protect the public health." Under FDC Act § 505(q), "[FDA] shall take final agency action on a petition not later than 180 days after the date on which the petition is submitted."

  5. Introducing the FDC Act § 505(q) Citizen Petition Tracker . . . .

    Hyman, Phelps & McNamara, P.C.October 21, 2008

    Last week, I presented at the Center for Business Intelligence’s Pharmaceutical Congress on Paragraph IV Disputes with Geoff Levitt of Wyeth on citizen petitions.The focus of my talk was on new FDC Act § 505(q) – “Petitions and Civil Actions Regarding Approval of Certain Applications” –which was added to the FDC Act by § 914 of the FDA Amendments Act (“FDAAA”).A copy of my presentation is available here.Briefly, FDC Act § 505(q) provides that FDA shall not delay approval of a pending ANDA or 505(b)(2) application as a result of a citizen petition submitted to the Agency pursuant to 21 C.F.R. § 10.30 or § 10.35, unless FDA “determines, upon reviewing the petition, that a delay is necessary to protect the public health.”Under the new law “[FDA] shall take final agency action on a petition not later than 180 days after the date on which the petition is submitted.”FDA may not extend the 180-day period “for any reason,” including consent of the petitioner.

  6. The Issue of Phthalates in Food Packaging and Processing Heats Up

    King & SpaldingSmitha StansburyFebruary 22, 2022

    xviiiIn response, FDA rejected two requests in the petition, declaring that: (1) a food additive petition could not be used to ban a chemical’s use as a food additive under 21 U.S.C. § 348(b)(1), and (2) chemical uses “approved” by FDA prior to 1958 are exempt from the definition of food additives under 21 U.S.C. § 321(s) (those commonly referred to as “prior sanctioned”). Instead, FDA advised that a citizen petition under 21 C.F.R. § 10.30 was the proper channel for these requests.FDA was still required to determine whether there is no longer “a reasonable certainty of no harm,” the applicable standard of safety for food additives and generally recognized as safe (GRAS) substances. FDA has yet to make this decision, and on December 7, 2021, the Environmental Defense Fund (and others) filed a petition for writ of mandamus with the U.S. Court of Appeals for the D.C. Circuit requesting that the court compel FDA to take final action on the Petition.

  7. FDA Alerts Pharmaceutical Manufacturers to Risk of Benzene in Certain Drugs

    King & SpaldingJanuary 5, 2022

    In addition to advances in analytical technology that allow manufacturers to detect impurities at very low levels, FDA’s heightened interest has been prompted, in part, by a series of findings by the Agency of benzene in consumer health products such as hand sanitizers and aerosol products.4 In addition to FDA’s findings, private analytical laboratories have filed Citizen Petitions with FDA under 21 C.F.R. § 10.30, which lead directly to personal injury, consumer class action, and attorney-general lawsuits against product manufacturers.FDA REGULATION OF BENZENE IN DRUGSFDA, adopting the International Conference on Harmonization (ICH) Q3C Impurities: Residual Solvents Guidance, classifies benzene as a Class 1 solvent, meaning it falls within one of the following three categories: known human carcinogens, strongly suspected human carcinogens, or environmental hazards.

  8. FDA Issues Guidance for Industry: “Section 503A Bulks List Final Rule Questions and Answers”: The Saga Continues….

    Hyman, Phelps & McNamara, P.C.Karla L. PalmerJune 7, 2019

    Those substances that “made the cut” and can be used in compounding include the following: (1) Brilliant Blue G, also known as Coomassie Brilliant Blue G-250; (2) cantharidin (for topical use only); (3) diphenylcyclopropenone (for topical use only); (4) N-acetyl-D-glucosamine (NAG) (for topical use only); (5) squaric acid dibutyl ester (for topical use only); and (6) thymol iodide (for topical use only). The four substances that did not make the cut are: (1) oxitriptan; (2) piracetam; (3) silver protein mild; and (4) tranilast.FDA states that if a compounder wants to use one of the four substances that did not make the list, then the compounder should file a citizen petition under 21 C.F.R. §10.30, and request that FDA consider revisiting the rule to include the bulk substance. Lastly, FDA’s Q&A lists the criteria it uses to evaluate bulk substances, which criteria are also listed in FDA’s final rule.

  9. FTC v. Shire ViroPharma

    Locke Lord LLPKeith ParrMarch 7, 2019

    The citizen-petition regulatory process allows any person or entity to submit a citizen petition ‎to FDA requesting that the agency “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(b)(3).‎ The Court acknowledged that “[t]he filing of a citizen petition can substantially delay ‎approval of a generic drug.”

  10. FDA’s Tenth Annual Report to Congress on 505(q) Citizen Petitions: New Numbers and the Same Message

    Hyman, Phelps & McNamara, P.C.Deborah L. LivorneseFebruary 12, 2019

    Although the statute provides that FDA may summarily deny a petition submitted with the primary purpose of delaying ANDA, 505(b)(2) application, or 351(k) biosimilar approval, the Agency has never done so. FDA’s actions and words continue to build a firmer basis and procedure for someday doing so.Under FDC Act § 505(q), FDA shall not delay approval of a pending ANDA, 505(b)(2) application, or 351(k) biosimilar application as a result of a citizen petition submitted to the Agency pursuant to 21 C.F.R. § 10.30 (citizen petition) or § 10.35 (petition for stay of action), unless FDA “determines, upon reviewing the petition, that a delay is necessary to protect the public health.” FDA is required to “take final agency action on a petition not later than 150 days after the date on which the petition is submitted.”