Sec. 301. Clarifying FDA regulation of non-addictive pain and addiction therapies

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Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall hold not less than one public meeting to address the challenges and barriers of developing non-addictive medical products intended to treat pain or addiction, which may include— the application of novel clinical trial designs (consistent with section 3021 of the 21st Century Cures Act ( Public Law 114–255 )), use of real world evidence (consistent with section 505F of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355g )), and use of patient experience data (consistent with section 569C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–8c )) for the development of non-addictive medical products intended to treat pain or addiction; and the application of eligibility criteria under sections 506 and 515B of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356 , 360e–3) for non-addictive medical products intended to treat pain or addiction.

Not later than one year after the public meetings are conducted under subsection

(a)the Secretary shall issue one or more final guidance documents, or update existing guidance documents, to help address challenges to developing non-addictive medical products to treat pain or addiction. Such guidance documents shall include information regarding— how the Food and Drug Administration may apply sections 506 and 515B of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356 , 360e–3) to non-addictive medical products intended to treat pain or addiction, including the circumstances under which the Secretary— may apply the eligibility criteria under such sections 506 and 515B to non-opioid or non-addictive medical products intended to treat pain or addiction; considers the risk of addiction of controlled substances approved to treat pain when establishing unmet medical need; and considers pain, pain control, or pain management in assessing whether a disease or condition is a serious or life-threatening disease or condition; and the methods by which sponsors may evaluate acute and chronic pain, endpoints for non-addictive medical products intended to treat pain, the manner in which endpoints and evaluations of efficacy will be applied across and within review divisions, taking into consideration the etiology of the underlying disease, and the manner in which sponsors may use surrogate endpoints, intermediate endpoints, and real world evidence. In this section, the term medical product means a drug (as defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(g)(1) )), biological product (as defined in section 351(i) of the Public Health Service Act ( 42 U.S.C. 262(i) )), or device (as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(h) )).

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