Sec. 304. CONDITIONAL APPROVAL OF NEW ANIMAL DRUGS
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## SEC. 304 CONDITIONAL APPROVAL OF NEW ANIMAL DRUGS ###
(a)In General Section 571 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ccc) is amended— ####
(1)in the section heading, by striking “species” and inserting “species and certain new animal drugs”; ####
(2)in subsection (a)— #####
(A)by amending paragraph
(1)to read as follows: > > #### “(1) > > > #####
(A)> > Except as provided in paragraph (3), any person may file with the Secretary an application for conditional approval of— > > > ###### “(i) > > a new animal drug intended for a minor use or a minor species; or > > > ###### “(ii) > > a new animal drug not intended for a minor use or minor species— > > > ###### “(I) > > that is intended to treat a serious or life-threatening disease or condition or addresses an unmet animal or human health need; and > > > ###### “(II) > > for which the Secretary determines that a demonstration of effectiveness would require a complex or particularly difficult study or studies. > > > ##### “(B) > > The Secretary shall, not later than September 30, 2019, issue guidance or regulations further clarifying the criteria specified in subparagraph (A)(ii). > > > ##### “(C) > > An application under this paragraph shall comply in all respects with the provisions of section 512 except for subsections (a)(4), (b)(2), (c)(1), (c)(2), (c)(3), (d)(1), (e), (h), and
(n)of such section unless otherwise stated in this section, and any additional provisions of this section. > > > ##### “(D) > > New animal drugs for which conditional approval is sought under this section are subject to the same safety standards that would be applied to new animal drugs under section 512(d) (including, for antimicrobial new animal drugs, with respect to antimicrobial resistance).” > ; and #####
(B)in paragraph (3)— ######
(i)in subparagraph (B), by striking “, or” and inserting “; or”; ######
(ii)by redesignating subparagraphs (A), (B), and
(C)as clauses (i), (ii), and (iii), respectively; ######
(iii)by striking “A person may not file” and inserting “(A) A person may not file”; and ######
(iv)by adding at the end the following new subparagraph: > > ##### “(B) > > A person may not file an application under paragraph (1)(A)(ii) if the application seeks conditional approval of a new animal drug that contains an antimicrobial active ingredient.” > ; ####
(3)in subsection (f)— #####
(A)in paragraph (1), in the matter preceding subparagraph (A), by inserting “for the conditionally approved use” after “shall”; and #####
(B)in paragraph (2)— ######
(i)by striking “An intended use” and inserting “The Secretary shall, through regulation or guidance, determine under what conditions an intended use”; and ######
(ii)by striking “shall not” and inserting “may”; and ####
(4)by adding at the end the following new subsection: > > ### “(k) Sunset > > > #### “(1) > > The Secretary’s authority to grant conditional approval of new animal drugs not intended for a minor use or minor species pursuant to subsection (a)(1)(A)(ii) terminates on October 1, 2028. > > > #### “(2) > > The Secretary— > > > ##### “(A) > > may not accept any new applications for such conditional approval pursuant to subsection (a)(1)(A)(ii) on or after such date; and > > > ##### “(B) > > may continue all activities under this section with respect to drugs that were conditionally approved pursuant to (a)(1)(A)(ii) prior to such date. > > > #### “(3) > > The Secretary may, until October 1, 2032, accept applications for approval under 512 of drugs conditionally approved pursuant to (a)(1)(A)(ii).” > . ###
(b)Exception From Fees in Case of Certain Previously Submitted Applications for Conditional Approval Section 740(a)(1)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-12(a)(1)(C)) is amended— ####
(1)in the caption by striking “Exception” and inserting “Exceptions”; ####
(2)by striking “ If an animal drug ” and inserting the following: > > ###### “(i) > > If an animal drug” > ; and ####
(3)by inserting after clause (i), as so designated, the following new clause: > > ###### “(ii) > > Beginning with fiscal year 2019, in the case of an animal drug application submitted by a person under section 512(b)(1), where such person (or their licensor, assignor, or predecessor-in-interest) previously submitted an application for conditional approval under section 571 for the same product and paid the applicable fee under subparagraph (A), the application under section 512(b)(1) shall not be subject to a fee under subparagraph
(A)if submitted within the timeframe specified in section 571(h).” > . ###
(c)Report on Incorporating Veterinary Oversight Not later than September 30, 2019, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall submit a report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate identifying how the Food and Drug Administration will incorporate veterinary oversight for all approved medically important antimicrobial drugs administered to animals that are not yet subject to veterinary oversight. Such report shall address requirements related to revisions of labeling to reflect that medically important antimicrobial drugs administered to animals shall be subject to veterinary oversight. ###
(d)GAO Study of Conditional Approval Programs ####
(1)Study The Comptroller General of the United States (referred to in this section as the “Comptroller General”) shall conduct a study on the effectiveness and overall impact of the conditional approval pathway under section 571 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ccc). ####
(2)Issuance of report Not later than January 1, 2026, the Comptroller General shall submit to the Committee on Health, Education, Labor and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report containing the results of the study under paragraph (1). ####
(3)Contents of reports The report submitted under paragraph
(2)shall address— #####
(A)for each drug for which a conditional approval has been awarded since October 1, 2018— ######
(i)whether the drug was granted conditional approval pursuant to clause
(i)or
(ii)of section 571(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act, as amended by subsection (a); ######
(ii)whether the drug was dual labeled during its conditional approval; ######
(iii)the indications for which the drug was granted conditional approval under section 571 of such Act (21 U.S.C. 360ccc) and whether the drug was approved or not approved under section 512 of such Act (21 U.S.C. 360b); ######
(iv)the number of years the drug was so conditionally approved and a description of the complexity of the investigation to demonstrate the drug’s effectiveness; ######
(v)whether, and to what extent, the conditional approval pathway under such section 571 (21 U.S.C. 360ccc) impacted the sponsor’s decision to develop the drug or seek approval of the drug under section 512 of such Act (21 U.S.C. 360b); ######
(vi)whether, and to what extent, conditional approval pursuant to clause
(ii)of section 571(a)(1)(A) of such Act (21 U.S.C. 360b(a)(1)(A)) addressed a serious or life-threatening condition; and ######
(vii)whether, and to what extent, conditional approval pursuant to clause
(ii)of section 571(a)(1)(A) of such Act (21 U.S.C. 360b(a)(1)(A)) addressed an unmet animal or human health need, and whether before such conditional approval there were available therapies for the disease or condition involved; #####
(B)an analysis of the conditional approval program under section 571 of such Act (21 U.S.C. 360ccc), including— ######
(i)the resources used by the Food and Drug Administration in reviewing applications for conditional approval of drugs pursuant to such program and renewal of such conditional approval, including the effects of the program on the Food and Drug Administration’s review of animal drugs for which conditional approval is not used; ######
(ii)whether any improvements to the program under section 512 of such Act (21 U.S.C. 360b) are necessary to incentivize the development of animal drugs that would likely not otherwise be developed, or developed in as timely a manner, to address— ######
(I)serious or life-threatening conditions; and ######
(II)an unmet animal or human health need; and ######
(iii)whether the conditional approval pathway has resulted in a greater number of animal drugs approved under section 512 of such Act (21 U.S.C. 360b) for serious or life-threatening conditions or unmet animal or human health needs than would have otherwise come to market under the practices and commitments of the Center for Veterinary Medicine of the Food and Drug Administration as such practices and commitments existed as of the day before the date of enactment of this Act; and #####
(C)how the Center for Veterinary Medicine of the Food and Drug Administration has utilized complex adaptive or other novel investigation designs, data from foreign countries, real-world evidence (including ongoing surveillance activities, observational studies, and registry data), biomarkers, or surrogate endpoints— ######
(i)to support the approval of products under section 512 of such Act (21 U.S.C. 360b), including how many such products have been approved since October 1, 2018; and ######
(ii)to support the approval of products under section 512 of such Act (21 U.S.C. 360b) that received conditional approval under section 571 of such Act (21 U.S.C. 360ccc), including how many such products have been approved since October 1, 2018.
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