S.Amdt. 1245
What it does: Adds SEC. _. REPORTING OF DATA IN APPLICATIONS FOR DRUGS, BIOLOGICAL PRODUCTS, AND DEVICES wherever appropriate
Sen. Debbie Stabenow (D-MI)What it changes
1 change to H.R. 1256
Adds SEC. _. REPORTING OF DATA IN APPLICATIONS FOR DRUGS, BIOLOGICAL PRODUCTS, AND DEVICES wherever appropriate
Adds a sectionInserted: SEC. _. REPORTING OF DATA IN APPLICATIONS FOR DRUGS, BIOLOGICAL PRODUCTS, AND DEVICES.
Inserted: (a) Drugs.--
Inserted: (1) New drug applications.--Section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) is amended--
Inserted: (A) in paragraph (1), in the second sentence--
Inserted: (i) by striking "drug, and (G)" and inserting "drug; (G)"; and
Inserted: (ii) by inserting before the period the following: "; and (H) the information required under paragraph (7)"; and
Inserted: (B) by adding at the end the following:
Inserted: "(7)(A) With respect to clinical data in an application under this subsection, the Secretary may deny such an application if the application fails to meet the requirements of sections 314.50(d)(5)(v) and 314.50(d)(5)(vi)(a) of title 21, Code of Federal Regulations.
Inserted: "(B) The Secretary shall modify the sections referred to in subparagraph (A) to require that an application under this subsection include any clinical data possessed by the applicant that relates to the safety or effectiveness of the drug involved by gender, age, and racial subgroup.
Inserted: "(C) Promptly after approving an application under this subsection, the Secretary shall, through an Internet site of the Department of Health and Human Services, make available to the public the information submitted to the Secretary pursuant to subparagraphs (A) and (B), subject to sections 301(j) and 520(h)(1) of this Act, subsection (b)(4) of section 552 of title 5, United States Code (commonly referred to as the 'Freedom of Information Act'), and other provisions of law that relate to trade secrets or confidential commercial information.
Inserted: "(D) The Secretary shall develop guidance for staff of the Food and Drug Administration to ensure that applications under this subsection are adequately reviewed to determine whether the applications include the information required pursuant to subparagraphs (A) and (B).".
Inserted: (2) Investigational new drug applications.--Section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) is amended--
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Inserted: (A) in paragraph (2), by striking "Subject to paragraph (3)," and inserting "Subject to paragraphs (3) and (5)," ; and
Inserted: (B) by adding at the end the following:
Inserted: "(5)(A) The Secretary may place a clinical hold (as described in paragraph (3)) on an investigation if the sponsor of the investigation fails to meet the requirements of section 312.33(a) of title 21, Code of Federal Regulations.
Inserted: "(B) The Secretary shall modify the section referred to in subparagraph (A) to require that reports under such section include any clinical data possessed by the sponsor of the investigation that relates to the safety or effectiveness of the drug involved by gender, age, and racial subgroup.".
Inserted: (b) Biological Product License Applications.--Section 351 of the Public Health Service Act (42 U.S.C. 262) is amended by adding at the end the following:
Inserted: "(k) The provisions of section 505(b)(7) of the Federal Food, Drug, and Cosmetic Act (relating to clinical data submission) apply with respect to an application under subsection (a) of this section to the same extent and in the same manner as such provisions apply with respect to an application under section 505(b) of such Act.".
Inserted: (c) Devices.--
Inserted: (1) Premarket approval.--Section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e) is amended--
Inserted: (A) in subsection (c)(1)--
Inserted: (i) in subparagraph (G)--
Inserted: (I) by moving the margin 2 ems to the left; and
Inserted: (II) by striking "and" after the semicolon at the end;
Inserted: (ii) by redesignating subparagraph (H) as subparagraph (I); and
Inserted: (iii) by inserting after subparagraph (G) the following subparagraph:
Inserted: "(H) the information required under subsection (d)(7); and"; and
Inserted: (B) in subsection (d), by adding at the end the following paragraph:
Inserted: "(7) To the extent consistent with the regulation of devices, the provisions of section 505(b)(7) (relating to clinical data submission) apply with respect to an application for premarket approval of a device under subsection (c) of this section to the same extent and in the same manner as such provisions apply with respect to an application for premarket approval of a drug under section 505(b).".
Inserted: (2) Investigational devices.--Section 520(g)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(g)(2)) is amended by adding at the end the following subparagraph:
Inserted: "(D) To the extent consistent with the regulation of devices, the provisions of section 505(i)(5) (relating to individual study information) apply with respect to an application for an exemption pursuant to subparagraph (A) of this paragraph to the same extent and in the same manner as such provisions apply with respect to an application for an exemption under section 505(i).".
Inserted: (d) Rules of Construction.--This Act and the amendments made by this Act may not be construed--
Inserted: (1) as establishing new requirements under the Federal Food, Drug, and Cosmetic Act relating to the design of clinical investigations that were not otherwise in effect on the day before the date of the enactment of this Act; or
Inserted: (2) as having any effect on the authority of the Secretary of Health and Human Services to enforce regulations under the Federal Food, Drug, and Cosmetic Act that are not expressly referenced in this Act or the amendments made by this Act.
Inserted: (e) Application.--This section and the amendments made by this section apply only with respect to applications received under section 505 or 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360e) or section 351 of the Public Health Service Act (42 U.S.C. 262) on or after the date of the enactment of this Act.
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Original wording
At the appropriate place, insert the following:
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As printed
SA 1245. Ms. STABENOW (for herself and Ms. Murkowski) submitted an amendment intended to be proposed by her to the bill H.R. 1256, to protect the public health by providing the Food and Drug Administration with certain authority to regulate tobacco products, to amend title 5, United States Code, to make certain modifications in the Thrift Savings Plan, the Civil Service Retirement System, and the Federal Employees' Retirement System, and for other purposes; which was ordered to lie on the table; as follows:
At the appropriate place, insert the following:
SEC. _. REPORTING OF DATA IN APPLICATIONS FOR DRUGS, BIOLOGICAL PRODUCTS, AND DEVICES.
(a) Drugs.--
(1) New drug applications.--Section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) is amended--
(A) in paragraph (1), in the second sentence--
(i) by striking “drug, and (G)” and inserting “drug; (G)”; and
(ii) by inserting before the period the following: “; and (H) the information required under paragraph (7)”; and
(B) by adding at the end the following:
“(7)(A) With respect to clinical data in an application under this subsection, the Secretary may deny such an application if the application fails to meet the requirements of sections 314.50(d)(5)(v) and 314.50(d)(5)(vi)(a) of title 21, Code of Federal Regulations.
“(B) The Secretary shall modify the sections referred to in subparagraph (A) to require that an application under this subsection include any clinical data possessed by the applicant that relates to the safety or effectiveness of the drug involved by gender, age, and racial subgroup.
“(C) Promptly after approving an application under this subsection, the Secretary shall, through an Internet site of the Department of Health and Human Services, make available to the public the information submitted to the Secretary pursuant to subparagraphs (A) and (B), subject to sections 301(j) and 520(h)(1) of this Act, subsection (b)(4) of section 552 of title 5, United States Code (commonly referred to as the ‘Freedom of Information Act'), and other provisions of law that relate to trade secrets or confidential commercial information.
“(D) The Secretary shall develop guidance for staff of the Food and Drug Administration to ensure that applications under this subsection are adequately reviewed to determine whether the applications include the information required pursuant to subparagraphs (A) and (B).”.
(2) Investigational new drug applications.--Section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) is amended--
(A) in paragraph (2), by striking “Subject to paragraph (3),” and inserting “Subject to paragraphs (3) and (5),” ; and
(B) by adding at the end the following:
“(5)(A) The Secretary may place a clinical hold (as described in paragraph (3)) on an investigation if the sponsor of the investigation fails to meet the requirements of section 312.33(a) of title 21, Code of Federal Regulations.
“(B) The Secretary shall modify the section referred to in subparagraph (A) to require that reports under such section include any clinical data possessed by the sponsor of the investigation that relates to the safety or effectiveness of the drug involved by gender, age, and racial subgroup.”.
(b) Biological Product License Applications.--Section 351 of the Public Health Service Act (42 U.S.C. 262) is amended by adding at the end the following:
“(k) The provisions of section 505(b)(7) of the Federal Food, Drug, and Cosmetic Act (relating to clinical data submission) apply with respect to an application under subsection (a) of this section to the same extent and in the same manner as such provisions apply with respect to an application under section 505(b) of such Act.”.
(c) Devices.--
(1) Premarket approval.--Section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e) is amended--
(A) in subsection (c)(1)--
(i) in subparagraph (G)--
(I) by moving the margin 2 ems to the left; and
(II) by striking “and” after the semicolon at the end;
(ii) by redesignating subparagraph (H) as subparagraph (I); and
(iii) by inserting after subparagraph (G) the following subparagraph:
“(H) the information required under subsection (d)(7); and”; and
(B) in subsection (d), by adding at the end the following paragraph:
“(7) To the extent consistent with the regulation of devices, the provisions of section 505(b)(7) (relating to clinical data submission) apply with respect to an application for premarket approval of a device under subsection (c) of this section to the same extent and in the same manner as such provisions apply with respect to an application for premarket approval of a drug under section 505(b).”.
(2) Investigational devices.--Section 520(g)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(g)(2)) is amended by adding at the end the following subparagraph:
“(D) To the extent consistent with the regulation of devices, the provisions of section 505(i)(5) (relating to individual study information) apply with respect to an application for an exemption pursuant to subparagraph (A) of this paragraph to the same extent and in the same manner as such provisions apply with respect to an application for an exemption under section 505(i).”.
(d) Rules of Construction.--This Act and the amendments made by this Act may not be construed--
(1) as establishing new requirements under the Federal Food, Drug, and Cosmetic Act relating to the design of clinical investigations that were not otherwise in effect on the day before the date of the enactment of this Act; or
(2) as having any effect on the authority of the Secretary of Health and Human Services to enforce regulations under the Federal Food, Drug, and Cosmetic Act that are not expressly referenced in this Act or the amendments made by this Act.
(e) Application.--This section and the amendments made by this section apply only with respect to applications received under section 505 or 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360e) or section 351 of the Public Health Service Act (42 U.S.C. 262) on or after the date of the enactment of this Act.
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Senate amendment submitted
June 3, 2009