H.R. 8840
Fair Care Act of 2026
Sponsor: Bruce Westerman · 0 cosponsors
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Text of the bill
I Modernization of health savings accounts
A Modernization of health savings accounts and contributions
B Assistance to health savings accounts
II Improving Private Health Insurance
A Maintaining Protections for Patients with Preexisting Conditions
B Expanding Coverage Options
C Improving Commercial Health Insurance
III Competition, Transparency and Accountability
A Provider and Insurer Competition
B Price Transparency
C Prescription Drug Competition and Innovation
Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended by adding at the end the following:
(aa) 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 (j)(5)(F), clause (iii) or (iv) of subsection (c)(3)(E), 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 (j)(5)(F), clauses (iii) and (iv) of subsection (c)(3)(E), 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 ensure 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 (j)(5)(F);
(ii) clause (iii) or (iv) of subsection (c)(3)(E); or
(iii) section 527(a); or
(C) except as expressly provided in paragraphs (1) and (2), the operation of this section or section 527.
D Prescription Drug and Pharmacy Benefit Manager Transparency
E Medicare and Medicaid Prescription Drug Reforms
F Medical Malpractice Reform
IV Medicare and Medicaid Reforms
A Medicaid Reforms
B Medicare Reforms
C Medicare Choice and Competition
D Telehealth Improvements and Expansion