A bill to require guidance on how the Food and Drug Administration will consider claims of opioid sparing and on the conditions under which the Food and Drug Administration will consider misuse and abuse of drugs in making certain determinations of safety.
This bill requires the Food and Drug Administration (FDA) to develop guidance regarding how it will assess evidence to support claims of opioid sparing (i.e., the use of drugs that reduce pain while also allowing reduced use or avoidance of oral opioids) for non-opioid or other non-addictive medical products intended to treat pain. The FDA must also develop guidance regarding how it will consider the misuse and abuse of drugs in making certain determinations of safety.
Administrative law and regulatory proceduresDepartment of Health and Human ServicesDrug, alcohol, tobacco useDrug safety, medical device, and laboratory regulationDrug trafficking and controlled substancesFood and Drug Administration (FDA)Government information and archivesHealth information and medical recordsMedical ethicsPrescription drugs
A bill to require guidance on how the Food and Drug Administration will consider claims of opioid sparing and on the conditions under which the Food and Drug Administration will consider misuse and abuse of drugs in making certain determinations of safety.
USA115th CongressS-2665| Senate
| Updated: 4/12/2018
This bill requires the Food and Drug Administration (FDA) to develop guidance regarding how it will assess evidence to support claims of opioid sparing (i.e., the use of drugs that reduce pain while also allowing reduced use or avoidance of oral opioids) for non-opioid or other non-addictive medical products intended to treat pain. The FDA must also develop guidance regarding how it will consider the misuse and abuse of drugs in making certain determinations of safety.
Administrative law and regulatory proceduresDepartment of Health and Human ServicesDrug, alcohol, tobacco useDrug safety, medical device, and laboratory regulationDrug trafficking and controlled substancesFood and Drug Administration (FDA)Government information and archivesHealth information and medical recordsMedical ethicsPrescription drugs