H.R. 843 — Prompt Approval of Safe Generic Drugs Act

This section establishes an exception permitting approval of new drug applications under subsections (b)(2) (i.e., applications relying in part on data not developed by the applicant) or (j) (i.e., abbreviated new drug applications) notwithstanding omission from labeling of safety information—including contraindications, warnings, precautions, dosing, administration, or other safety details—protected by specified exclusivities ((c)(3)(E)(iii)/(iv), (j)(5)(F)(iii)/(iv), or 527(a)), exclusivity extensions (505A or 505E), or patents. Notwithstanding those protections, the FDA must require inclusion in such labeling of any safety information the agency deems necessary to ensure safe use. The provision does not alter the availability or scope of those exclusivities or extensions, eligibility based on omission of nonsafety labeling protected by exclusivity, or other operations of the section or 527.