Sec. 3001. CLARIFYING FDA REGULATION OF NON-ADDICTIVE PAIN PRODUCTS

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## SEC. 3001 CLARIFYING FDA REGULATION OF NON-ADDICTIVE PAIN PRODUCTS **[**[21 U.S.C. 355 note](/us/usc/t21/s355)**]** ###

(a)Public Meetings Not later than one year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the “Secretary”), 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 acute or chronic pain or addiction, which may include— ####

(1)the manner by which the Secretary may incorporate the risks of misuse and abuse of a controlled substance (as defined in section 102 of the Controlled Substances Act (21 U.S.C. 802)) into the risk benefit assessments under subsections

(d)and

(e)of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), section 510(k) of such Act (21 U.S.C. 360(k)), or section 515(c) of such Act (21 U.S.C. 360e(c)), as applicable; ####

(2)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; ####

(3)the evidentiary standards and the development of opioid-sparing data for inclusion in the labeling of medical products intended to treat acute or chronic pain; and ####

(4)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. ###

(b)Guidance Not less 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— ####

(1)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— #####

(A)may apply the eligibility criteria under such sections 506 and 515B to non-addictive medical products intended to treat pain or addiction; #####

(B)considers the risk of addiction of controlled substances approved to treat pain when establishing unmet medical need; and #####

(C)considers pain, pain control, or pain management in assessing whether a disease or condition is a serious or life-threatening disease or condition; ####

(2)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; ####

(3)the manner in which the Food and Drug Administration will assess evidence to support the inclusion of opioid-sparing data in the labeling of non-addictive medical products intended to treat acute or chronic pain, including— #####

(A)alternative data collection methodologies, including the use of novel clinical trial designs (consistent with section 3021 of the 21st Century Cures Act (Public Law 114-255)) and real world evidence (consistent with section 505F of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355g)), including patient registries and patient reported outcomes, as appropriate, to support product labeling; #####

(B)ethical considerations of exposing subjects to controlled substances in clinical trials to develop opioid-sparing data and considerations on data collection methods that reduce harm, which may include the reduction of opioid use as a clinical benefit; #####

(C)endpoints, including primary, secondary, and surrogate endpoints, to evaluate the reduction of opioid use; #####

(D)best practices for communication between sponsors and the agency on the development of data collection methods, including the initiation of data collection; and #####

(E)the appropriate format in which to submit such data results to the Secretary; and ####

(4)the circumstances under which the Food and Drug Administration considers misuse and abuse of a controlled substance (as defined in section 102 of the Controlled Substances Act (21 U.S.C. 802)) in making the risk benefit assessment under paragraphs

(2)and

(4)of subsection

(d)of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and in finding that a drug is unsafe under paragraph

(1)or

(2)of subsection

(e)of such section. ###

(c)Definitions In this section— ####

(1)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))); and ####

(2)the term “opioid-sparing” means reducing, replacing, or avoiding the use of opioids or other controlled substances intended to treat acute or chronic pain.

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