Prompt Approval of Safe Generic Drugs Act

Bill: 117-hr-2831
Sponsor: full_name: Rep. Barragan, Nanette Diaz [D-CA-44]
Introduced: 2021-04-26
Policy area: Health
Subjects: Drug safety, medical device, and laboratory regulation

Marketing and advertising
Latest action: action_date: 2021-04-27
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2021-04-26
action_desc: Introduced in House
text: <p><strong>Prompt Approval of Safe Generic Drugs Act</strong></p> <p>This bill authorizes the Food and Drug Administration (FDA) to approve certain applications to market a drug even if the drug's labeling lacks certain safety information.</p> <p>Specifically, an abbreviated application for approval of a generic drug shall not be ineligible for approval solely because the drug's labeling omits safety information that is protected under another drug's exclusivity protections. Similarly, a drug that is approved under this bill shall not be considered mislabeled for lacking such safety information. </p> <p>Generally, an abbreviated application, for the purposes of this bill, is one that (1) uses required information from studies not conducted by the applicant; or (2) seeks approval of a drug that is, for drug approval purposes, a duplicate of an already-approved drug.</p> <p>For any drug approved under this bill, the FDA shall require the drug's labeling to include any safety information that is necessary to assure safe use.</p>

tv_txt: I 117th CONGRESS 1st Session H. R. 2831 IN THE HOUSE OF REPRESENTATIVES April 26, 2021 Ms. Barragán introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Federal Food, Drug, and Cosmetic Act to provide for the prompt approval of drugs when safety information is added to labeling, and for other purposes.

1. Short title This Act may be cited as the Prompt Approval of Safe Generic Drugs Act . 2. Heading Section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) is amended by adding at the end the following: (z) Prompt approval of drugs when safety information is added to labeling (1) General rule A drug for which an application has been submitted or approved under subsection (b)(2) or (j) shall not be considered ineligible for approval under this section or misbranded under section 502 on the basis that the labeling of the drug omits safety information, including contraindications, warnings, precautions, dosing, administration, or other information pertaining to safety, when the omitted safety information is protected by exclusivity under clause (iii) or (iv) of subsection (c)(3)(E), clause (iii) or (iv) of subsection (j)(5)(F), or section 527(a), or by an extension of such exclusivity under section 505A or 505E. (2) Labeling Notwithstanding clauses (iii) and (iv) of subsection (c)(3)(E), clauses (iii) and (iv) of subsection (j)(5)(F), or section 527, the Secretary shall require that the labeling of a drug approved pursuant to an application submitted under subsection (b)(2) or (j) that omits safety information described in paragraph (1) include a statement of any appropriate safety information that the Secretary considers necessary to assure safe use. (3) Availability and scope of exclusivity This subsection does not affect— (A) the availability or scope of exclusivity or an extension of exclusivity described in subparagraph (A) or (B) of section 505A(o)(3); (B) the question of the eligibility for approval under this section of any application described in subsection (b)(2) or (j) that omits any other aspect of labeling protected by exclusivity under— (i) clause (iii) or (iv) of subsection (c)(3)(E); (ii) clause (iii) or (iv) of subsection (j)(5)(F); or (iii) section 527(a); or (C) except as expressly provided in paragraphs (1) and (2), the operation of this section or section 527. .