HR 6972 — Give Kids a Chance Act of 2022

Summary

Give Kids a Chance Act of 2022 This bill authorizes the Food and Drug Administration (FDA) to take various actions regarding pediatric cancer treatments, such as requiring pediatric cancer trials involving a combination of drugs when an applicant seeks market approval for a new drug (or biological product).

Bill Text

• Introduced Introduced in House Current html March 08, 2022

Compared against current U.S. Code AI-generated reading aid — verify against the official bill.

The bill amends existing law to enhance the FDA's authority in pediatric investigations of molecularly targeted drugs for cancer treatment, particularly focusing on novel combinations and preclinical studies.

• 21 U.S.C. 355c(a)(1)(B)

  or an application under such section 505 or such section 351 for a drug or biological product that contains a novel combination of two or more active ingredients (subject to paragraph (3)(B)(iii))

  The bill expands the scope of applications to include drugs with novel combinations of active ingredients.

• 21 U.S.C. 355c(a)(3)

  subparagraph (A) → (A) In general.--For purposes of paragraph (1)(B), the investigation described in this paragraph is (as determined by the Secretary) a molecularly targeted pediatric cancer investigation of--

  This change specifies the types of investigations that qualify under the section, ensuring clarity regarding molecularly targeted pediatric cancer investigations.

• 21 U.S.C. 355c(a)(3)

  subparagraphs (B) and (C) → subparagraphs (C) and (D)

  This change renumbers the subparagraphs to accommodate the new structure, ensuring that the legal references remain consistent.

• 21 U.S.C. 355c(a)(3)(A)(ii)

  (II) an active ingredient of a drug for which an approved application under section 505(b) is in effect to treat an adult cancer, or an active ingredient of a biological product for which an approved application under section 351(a) of the Public Health Service Act is in effect to treat an adult cancer, which approved application is held by the same person submitting the application referred to in paragraph (1)(B);

  This establishes conditions under which combinations with active ingredients for adult cancer treatments can be part of pediatric investigations.

• 21 U.S.C. 355c(a)(3)(B)(iii)

  For purposes of paragraph (1)(B), a novel combination is a combination of two or more active ingredients for which an application under section 505 of this Act or section 351 of the Public Health Service Act for such combination has not previously been approved.

  Defines what constitutes a novel combination, leading to more precise criteria for investigations.

• 21 U.S.C. 355c(a)(1)

  (C) Preclinical studies generally.--

  This addition gives the Secretary authority to require preclinical studies for investigational exemptions related to adult cancer treatments.

• 21 U.S.C. 355c(a)(3)(B)(ii)

  The purpose of a molecularly targeted pediatric cancer investigation referred to in subparagraph (A) shall be--

  Clarifies the dual purpose of investigations regarding labeling and molecular target relevance.

• 21 U.S.C. 355c(a)(3)(B)(iv)

  The Secretary may require that reports on an investigation required pursuant to paragraph (1)(B) shall include the results of all preclinical studies on which the decision to conduct such investigation was based.

  Ensures that preclinical data is part of the investigational reports, enhancing regulatory oversight.

• 21 U.S.C. 355c(a)(3)(E)

  Internal committee review; labeling changes; dissemination of information; adverse events; scope of authority.--Subsections (f) through (j) shall apply with respect to investigations described in this paragraph to the same extent and in the same manner as such subsections apply with respect to the assessments required under paragraph (1)(A), except that subsection (g) does not apply with respect to an investigation referred to in subparagraph (A)(ii) of this paragraph.

  Expands the applicability of internal review and regulatory provisions to pediatric investigations.

Action History

1. March 09, 2022

   Referred to the Subcommittee on Health.

2. March 08, 2022

   Introduced in House

3. March 08, 2022

   Introduced in House

4. March 08, 2022

   Referred to the House Committee on Energy and Commerce.

Sponsors

• G. K. Butterfield · Primary

Subjects