Actions

No actions available.

Full Text of this Amendment

SA 1046. Ms. STABENOW (for herself, Mr. Kohl, Mr. Hatch, and Mr. Coburn) submitted an amendment intended to be proposed by her to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; which was ordered to lie on the table; as follows:

At the appropriate place, insert the following:
SEC. __. CITIZENS PETITIONS AND PETITIONS FOR STAY OF AGENCY ACTION.
Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), as amended by this Act, is amended by adding at the end the following:
``(s) Citizen Petitions and Petitions for Stay of Agency Action.--
``(1) IN GENERAL.--
``(A) NO DELAY OF CONSIDERATION OR APPROVAL.--
``(i) IN GENERAL.--With respect to a pending application submitted under subsection (b)(2) or (j), if a petition is submitted to the Secretary that seeks to have the Secretary take, or refrain from taking, any form of action relating to the approval of the application, including a delay in the effective date of the application, clauses (ii) and (iii) shall apply.
``(ii) NO DELAY OF CONSIDERATION OR APPROVAL.--Except as provided in clause (iii), the receipt and consideration of a petition described in clause (i) shall not delay consideration or approval of an application submitted under subsection (b)(2) or (j).
``(iii) NO DELAY OF APPROVAL WITHOUT DETERMINATION.--The Secretary shall not delay approval of an application submitted under subsection (b)(2) or (j) while a petition described in clause (i) is reviewed and considered unless the Secretary determines, not later than 25 business days after the submission of the petition, that a delay is necessary to protect the public health.
``(B) DETERMINATION OF DELAY.--With respect to a determination by the Secretary under subparagraph (A)(iii) that a delay is necessary to protect the public health the following shall apply:
``(i) Not later than 5 days after making such determination, the Secretary shall publish on the Internet website of the Food and Drug Administration a detailed statement providing the reasons underlying the determination. The detailed statement shall include a summary of the petition and comments and supplements, the specific substantive issues that the petition raises which need to be considered prior to approving a pending application submitted under subsection (b)(2) or (j), and any clarifications
and additional data that is needed by the Secretary to promptly review the petition.
``(ii) Not later than 10 days after making such determination, the Secretary shall provide notice to the sponsor of the pending application submitted under subsection (b)(2) or (j) and provide an opportunity for a meeting with appropriate staff as determined by the Commissioner to discuss the determination.
``(2) TIMING OF FINAL AGENCY ACTION ON PETITIONS.--
``(A) IN GENERAL.--Notwithstanding a determination made by the Secretary under paragraph (1)(A)(iii), the Secretary shall take final agency action with respect to a petition not later than 180 days of submission of that petition unless the Secretary determines, prior to the date that is 180 days after the date of submission of the petition, that a delay is necessary to protect the public health.
``(B) DETERMINATION OF DELAY.--With respect to a determination by the Secretary under subparagraph (A) that a delay is necessary to protect the public health the following shall apply:
``(i) Not later than 5 days after making the determination under subparagraph (A), the Secretary shall publish on the Internet website of the Food and Drug Administration a detailed statement providing the reasons underlying the determination. The detailed statement should include the state of the review of the petition, the specific outstanding issues that still need to be resolved, a proposed timeframe to resolve the issues, and any additional information that has been requested by the Secretary
of the petitioner or needed by the Secretary in order to resolve the petition and not further delay an application filed under subsection (b)(2) or (j).
``(ii) Not later than 10 days after making the determination under subparagraph (A), the Secretary shall provide notice to the sponsor of the pending application submitted under subsection (b)(2) or (j) and provide an opportunity for a meeting with appropriate staff as determined by the Commissioner to discuss the determination.
``(3) VERIFICATIONS.--
``(A) PETITIONS FOR REVIEW.--The Secretary shall not accept a petition for review unless it is signed and contains the following verification: `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) information upon which I have based the action requested herein first became
known to the party on whose behalf this petition is filed on or about __XXXXXXXX. I received or expect to receive payments, including cash and other forms of consideration, from the following persons or organizations to file this petition:
__XXXXXX. I verify under penalty of perjury that the foregoing is true and correct.', with the date of the filing of such petition and the signature of the petitioner inserted in the first and second blank space, respectively.

``(B) SUPPLEMENTAL INFORMATION.--The Secretary shall not accept for review any supplemental information or comments on a petition unless the party submitting such information or comments does so in written form and that the subject document is signed and contains the following 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 __XXXXXXXX. I received or expect to receive payments, including cash and other forms of consideration, from the following persons or organizations to submit this information or its contents:
__XXX. I verify under penalty of perjury that the foregoing is true and correct.', with the date of the submission of such document and the signature of the petitioner inserted in the first and second blank space, respectively.

``(4) ANNUAL REPORT ON DELAYS IN APPROVALS PER PETITION.--The Secretary shall annually submit to the Congress a report that specifies--
``(A) the number of applications under subsection (b)(2) and (j) that were approved during the preceding 1-year period;
``(B) the number of petitions that were submitted during such period;
``(C) the number of applications whose effective dates were delayed by petitions during such period and the number of days by which the applications were so delayed; and
``(D) the number of petitions that were filed under this subsection that were deemed by the Secretary under paragraph (1)(A)(iii) to require delaying an application under subsection (b)(2) or (j) and the number of days by which the applications were so delayed.
``(5) EXCEPTION.--This subsection does not apply to a petition that is made by the sponsor of the application under subsection (b)(2) or (j) and that seeks only to have the Secretary take or refrain from taking any form of action with respect to that application.
``(6) REPORT BY INSPECTOR GENERAL.--The Office of Inspector General of the Department of Health and Human Services shall issue a report not later than 2 years after the date of enactment of this subsection evaluating evidence of the compliance of the Food and Drug Administration with the requirement that the consideration by the Secretary of petitions that do not raise public health concerns remain separate and apart from the review and approval of an application submitted under subsection
(b)(2) or (j).
``(7) DEFINITION.--For purposes of this subsection, the term `petition' includes any request for an action described in paragraph (1)(A)(i) to the Secretary, without regard to whether the request is characterized as a petition.''.



(As printed in the Congressional Record for the Senate on May 7, 2007.)