U.S Code last checked for updates: May 26, 2024
§ 284m.
Program for pediatric studies of drugs
(a)
List of priority issues in pediatric therapeutics
(1)
In general
(2)
Consideration of available information
In developing and prioritizing the list under paragraph (1), the Secretary—
(A)
shall consider—
(i)
therapeutic gaps in pediatrics that may include developmental pharmacology, pharmacogenetic determinants of drug response, metabolism of drugs and biologics in children, and pediatric clinical trials;
(ii)
particular pediatric diseases, disorders or conditions where more complete knowledge and testing of therapeutics, including drugs and biologics, and identification of biomarkers for such diseases, disorders, or conditions, may be beneficial in pediatric populations; and
(iii)
the adequacy of necessary infrastructure to conduct pediatric pharmacological research, including research networks and trained pediatric investigators; and
(B)
may consider the availability of qualified countermeasures (as defined in section 247d–6a of this title), security countermeasures (as defined in section 247d–6b of this title), and qualified pandemic or epidemic products (as defined in section 247d–6d of this title) to address the needs of pediatric populations, in consultation with the Assistant Secretary for Preparedness and Response, consistent with the purposes of this section.
(b)
Pediatric studies and research
(c)
Process for proposed pediatric study requests and labeling changes
(1)
Submission of proposed pediatric study request
The Director of the National Institutes of Health shall, as appropriate, submit proposed pediatric study requests for consideration by the Commissioner of Food and Drugs for pediatric studies of a specific pediatric indication identified under subsection (a). Such a proposed pediatric study request shall be made in a manner equivalent to a written request made under subsection (b) or (c) of section 505A of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355a], or section 262(m) of this title, including with respect to the information provided on the pediatric studies to be conducted pursuant to the request. The Director of the National Institutes of Health may submit a proposed pediatric study request for a drug for which—
(A)
(i)
there is an approved application under section 505(j) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(j)] or section 262(k) of this title; or
(ii)
there is a submitted application that could be approved under the criteria of such section; and
(B)
there remains no patent listed pursuant to section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(b)(1)], and every three-year and five-year period referred to in subsection (c)(3)(E)(ii), (c)(3)(E)(iii), (c)(3)(E)(iv), (j)(5)(F)(ii), (j)(5)(F)(iii), or (j)(5)(F)(iv) of section 505 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355], or applicable twelve-year period referred to in section 262(k)(7) of this title, and any seven-year period referred to in section 527 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360cc] has ended for at least one form of the drug; and
(C)
additional studies are needed to assess the safety and effectiveness of the use of the drug in the pediatric population.
(2)
Written request to holders of approved applications
(3)
Requests for proposals
(4)
Disqualification
(5)
Contracts, grants, or other funding mechanisms
(6)
Reporting of studies
(A)
In general
(B)
Availability of reports
(i)
In general
Each report submitted under subparagraph (A) shall be considered to be in the public domain (subject to section 505A(d)(4) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355a(d)(4)]) and not later than 90 days after submission of such report, shall be—
(I)
posted on the internet website of the National Institutes of Health in a manner that is accessible and consistent with all applicable Federal laws and regulations, including such laws and regulations for the protection of—
(aa)
human research participants, including with respect to privacy, security, informed consent, and protected health information; and
(bb)
proprietary interests, confidential commercial information, and intellectual property rights; and
(II)
assigned a docket number by the Commissioner of Food and Drugs and made available for the submission of public comments.
(ii)
Submission of comments
(C)
Action by Commissioner
(7)
Requests for labeling change
Within the 180-day period after the date on which a report is submitted under paragraph (6)(A), the Commissioner of Food and Drugs shall—
(A)
review the report and such other data as are available concerning the safe and effective use in the pediatric population of the drug studied;
(B)
negotiate with the holders of approved applications for the drug studied for any labeling changes that the Commissioner of Food and Drugs determines to be appropriate and requests the holders to make; and
(C)
(i)
include in the public docket file a reference to the location of the report on the internet website of the National Institutes of Health and a copy of any requested labeling changes; and
(ii)
publish through a posting on the Web site of the Food and Drug Administration a summary of the report and a copy of any requested labeling changes.
(8)
Dispute resolution
(A)
Referral to Pediatric Advisory Committee
(B)
Action by the Pediatric Advisory Committee
Not later than 90 days after receiving a referral under subparagraph (A), the Pediatric Advisory Committee shall—
(i)
review the available information on the safe and effective use of the drug in the pediatric population, including study reports submitted under this section; and
(ii)
make a recommendation to the Commissioner of Food and Drugs as to appropriate labeling changes, if any.
(9)
FDA determination
(10)
Failure to agree
(11)
No effect on authority
(d)
Authorization of appropriations
(1)
In general
(2)
Availability
(July 1, 1944, ch. 373, title IV, § 409I, as added Pub. L. 107–109, § 3(3), Jan. 4, 2002, 115 Stat. 1408; amended Pub. L. 108–155, § 3(b)(6), Dec. 3, 2003, 117 Stat. 1942; Pub. L. 109–482, title I, § 103(b)(14), Jan. 15, 2007, 120 Stat. 3687; Pub. L. 110–85, title V, § 502(b), Sept. 27, 2007, 121 Stat. 886; Pub. L. 111–148, title VII, § 7002(g)(2)(A), Mar. 23, 2010, 124 Stat. 820; Pub. L. 112–144, title V, §§ 507(d), 509(d), July 9, 2012, 126 Stat. 1045, 1049; Pub. L. 113–5, title III, § 307(b), Mar. 13, 2013, 127 Stat. 192; Pub. L. 115–52, title V, § 501, Aug. 18, 2017, 131 Stat. 1036; Pub. L. 117–180, div. F, title V, § 5001, Sept. 30, 2022, 136 Stat. 2167; Pub. L. 117–229, div. C, title III, § 302, Dec. 16, 2022, 136 Stat. 2312; Pub. L. 117–328, div. FF, title III, § 3102, Dec. 29, 2022, 136 Stat. 5807.)
cite as: 42 USC 284m