Transcript Document
CBI Pharmaceutical Congress on Paragraph IV Disputes:
Citizen Petitions and Their Impact on Generic Entry
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Kurt R. Karst Hyman, Phelps & McNamara, P.C.
www.hpm.com
202-737-7544 www.hpm.com
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[email protected]
2 FDAAA
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914 & FDC Act
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505(q) – Dissecting the New CP Law
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FDA shall not delay approval of a pending ANDA or 505(b)(2) application “because of any request to take any form of action relating to the application, either before or during consideration of the request, unless” –
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The request is in writing and is a petition submitted to FDA pursuant to 21 C.F.R.
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10.30 or
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10.35; and
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FDA determines, upon reviewing the petition, that a delay is necessary to protect the public health.
3 FDAAA
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914 & FDC Act
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505(q) – Dissecting the New CP Law
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“Consideration of the petition shall be separate and apart from review and approval of any application.”
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Added by the Animal Drug User Fee Amendments of 2008.
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FDA has been criticized for its implementation of FDC Act
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505(q), and, in particular for not decoupling ANDA approval from responding to an applicable petition that could delay generic competition. See Sen. Stabenow (D-MI) April 2008 letter to FDA.
4 FDAAA
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914 & FDC Act
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505(q) – Dissecting the New CP Law
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Delay notification requirement. If FDA determines that a delay is necessary with respect to an application, not later than 30 days after making such determination, FDA shall provide to the applicant –
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A determination notification; “[A]ny clarification or additional data that the applicant should submit to the docket on the petition to allow [FDA] to review the petition promptly;” and “A brief summary of the specific substantive issues raised in the petition which form the basis of the determination.”
5 FDAAA
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914 & FDC Act
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505(q) – Dissecting the New CP Law
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Denial based on intent to delay.
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“If [FDA] determines that a petition or a supplement to the petition was submitted with the primary purpose of delaying the approval of an application and the petition does not on its face raise valid scientific or regulatory issues, [FDA] may deny the petition at any point based on such determination.”
6 FDAAA
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914 & FDC Act
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505(q) – Dissecting the New CP Law
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Final agency action.
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“[FDA] shall take final agency action on a petition not later than 180 days after the date on which the petition is submitted.”
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FDA may not extend the 180-day period “for any reason,” including consent of the petitioner.
7 FDAAA
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914 & FDC Act
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505(q) – Dissecting the New CP Law
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Extension of 30-month 180-day exclusivity forfeiture period.
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If the filing of an ANDA resulted in first applicant status and ANDA approval was delayed because of a petition, the 30-month period under FDC Act months)
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505(j)(5)(D)(i)(IV) (failure to obtain tentative approval within 30
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“is deemed to be extended by a period of time equal to the period beginning on the date on which [FDA] received the petition and ending on the date of final agency action on the petition (inclusive of such beginning and ending dates), without regard to whether [FDA] grants, in whole or in part, or denies, in whole or in part, the petition.”
8 FDAAA
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914 & FDC Act
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505(q) – Dissecting the New CP Law
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Certification & verification requirement
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A certification statement (original petition) or verification statement (petition supplement or comment) must accompany each docket submission.
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FDA will not accept for review a petition or any supplemental information or petition comments unless the certification or verification statement is included.
9 FDAAA
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914 & FDC Act
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505(q) – Dissecting the New CP Law
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Certification
– I certify that, to my best knowledge and belief: (a) this petition includes all information and views upon which the petition relies; (b) this petition includes representative data and/or information known to the petitioner which are unfavorable to the petition; and (c) I have taken reasonable steps to ensure that any representative data and/or information which are unfavorable to the petition were disclosed to me. I further certify that the information upon which I have based the action requested herein first became known to the party on whose behalf this petition is submitted on or about the following date: _______________. If I received or expect to receive payments, including cash and other forms of consideration, to file this information or its contents, I received or expect to receive those payments from the following persons or organizations: _______________. I verify under penalty of perjury that the foregoing is true and correct as of the date of the submission of this petition.
10 FDAAA
§
914 & FDC Act
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505(q) – Dissecting the New CP Law
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Verification
– I certify that, to my best knowledge and belief: (a) I have not intentionally delayed submission of this document or its contents; and (b) the information upon which I have based the action requested herein first became known to me on or about _______________. If I received or expect to receive payments, including cash and other forms of consideration, to file this information or its contents, I received or expect to receive those payments from the following persons or organizations: __________. I verify under penalty of perjury that the foregoing is true and correct as of the date of the submission of this petition.
11 FDAAA
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914 & FDC Act
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505(q) – Dissecting the New CP Law
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Exhaustion of administrative remedies.
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Final agency action
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“[FDA] shall be considered to have taken final agency action on a petition if – (i) during the 180-day period . . . the [Agency] makes a final decision within the meaning of [21 C.F.R.
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10.45(d)]; or (ii) such period expires without [FDA] having made such a final decision.”
12 FDAAA
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914 & FDC Act
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505(q) – Dissecting the New CP Law
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Administrative record.
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For purposes of judicial review related to the approval of an ANDA or 505(b)(2) application affected by a
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505(q) CP, the administrative record regarding any issue raised by the petition includes –
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The CP and any supplements and comments; FDA’s CP response (if any); and
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“[O]ther information, as designated by [FDA], related to [FDA’s] determinations regarding the issues raised in such petition,” provided such information was considered by FDA no later than the date that is 180-days after CP submission.
13 FDAAA
§
914 & FDC Act
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505(q) – Dissecting the New CP Law
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505(q) CP exceptions.
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FDC Act
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505(q) does not apply to – A CP that relates “solely to the timing of the approval of an application pursuant to subsection (j)(5)(B)(iv)” (i.e., 180-day exclusivity); or
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A CP that is made by the ANDA or 505(b)(2) sponsor “and that seeks only to have [FDA] take or refrain from taking any form of action with respect to that application.”
FDAAA
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914 & FDC Act
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505(q) – Dissecting the New CP Law 14
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Questions & Issues.
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Intent to delay delay?
– How is it determined? Should the law be amended to define intent to
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“[FDA] may issue guidance to describe the factors that will be used to determine under this subparagraph whether a petition is submitted with the primary purpose of delaying the approval of an application.”
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Extension of the 30-month tentative approval 180-day exclusivity forfeiture period Act
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505(j)(5)(D)(i)(I)(aa)(BB)?
– But what about the 30-month period under FDC
15 FDAAA
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914 & FDC Act
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505(q) – Dissecting the New CP Law
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Why exclude CPs solely concerning 180 day exclusivity?
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Can a pre-FDAAA CP become subject to FDC Act
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505(q) via a petition supplement or comment?
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FDA’s failure to respond to a CP within 180 days is not a petition denial, but “final agency action.” What does this mean for challenging such “final agency action”?
16 FDAAA
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914 & FDC Act
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505(q) – Dissecting the New CP Law
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FDA is reportedly interpreting FDC Act
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505(q) to apply to CPs that are submitted after an ANDA is submitted. FDC Act
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505(q)(1)(A) refers to a “pending application.” However, FDA will not reveal to a petitioner whether an ANDA is pending. Therefore, the petitioner will not know if the 180-day deadline applies, unless a generic applicant says it has submitted an ANDA or FDA’s Paragraph IV list provides that notice. If a CP is submitted too soon, the 180-day deadline would not apply.
17 FDAAA
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914 & FDC Act
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505(q) – Dissecting the New CP Law
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October 10, 2008 FDA response largely denying two CPs concerning pancreatic enzyme products.
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FDA notes that while 505(q) requires the Agency to take action on a CP within 180 days, the Agency cannot make any final decisions concerning the approvability of NDAs.
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“There is no evidence that in enacting section 505(q) of the Act, Congress intended to vitiate an NDA applicant's procedural rights by requiring that the Agency make decisions that constitute final Agency action regarding the approvability of aspects that are specific to a pending application (e.g., specific claims proposed in a drug product's labeling) on a piecemeal basis outside of the process established under the Act and regulations.”
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FDA’s Post-FDAAA Petition Response Track Record
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According to information on Regulations.gov, 28 CPs with the FDC Act
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505(q) certification have been submitted to FDA since FDAAA’s enactment.
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11 Denied; 2 Granted/Denied in part; 14 Pending; and 1 Withdrawn.
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FDA’s Post-FDAAA Petition Response Track Record
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FDA’s 180-day response time has expired in a few cases for pending CPs. No legal action has yet been taken with respect to these petitions.
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Several important CP decisions are due in the November and December timeframes.
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FDA’s Post-FDAAA Petition Response Track Record
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FDAAA CP reports
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Annual report (overdue) detailing –
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The number of applications that were approved during the preceding 12-month period;
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The number of such applications whose effective dates were delayed by
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505(q) CPs;
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The number of days by which such applications were delayed; and
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The number of CPs that were submitted during such period.
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FDA’s Post-FDAAA Petition Response Track Record
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1-Year report (overdue) –
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“Not later than 1 year after the date of [FDAAA], the Secretary of Health and Human Services shall submit a report to the Congress on ways to encourage the early submission of petitions under section 505(q) . . . .
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