and Cosmetic Act or section 351 of the Public Health Service Act, as applicable. (6) Utilization of real world evidence to support full approval The Secretary shall allow the use of real world evidence, as defined in section 505F(b), and collected by the sponsor of a drug during the duration of conditional approval granted approval to this subsection, to supplement an application for full approval, in addition to other post-approval studies. (c) Limitation on liability (1) In general With respect to any claim under State law alleging that a drug sold or otherwise made available pursuant to a grant of conditional approval under this section is unsafe or ineffective, no liability in a cause of action shall lie against a sponsor or manufacturer, unless the relevant conduct constitutes reckless or willful misconduct, gross negligence, or an intention tort under any applicable State law. (2) Rule of construction Except as set forth in subparagraph (A), nothing in this subsection shall be construed to modify or otherwise affect the right of any person to bring private action under any Federal or State product liability, tort, consumer protection, or warranty law. (d) Definitions In this Act: (1) Seriously debilitating diseases The term severely debilitating diseases means diseases or conditions that cause major irreversible morbidity. (2) Life-threatening diseases The term life-threatening diseases means— (A) a disease or condition where the likelihood of death is high unless the course of the disease is interrupted