Addiction Prevention and Responsible Opioid Practices Act
This bill addresses prescription opioid misuse.
The Food and Drug Administration (FDA) must: (1) seek recommendations concerning opioid drugs from an FDA advisory committee relating to the approval of a new drug that is an opioid, and the labeling of opioid drugs for pediatric prescriptions; (2) develop recommendations for education programs for prescribers of opioids; and (3) issue guidance for labeling that deters opioid abuse.
The bill amends the Federal Food, Drug, and Cosmetic Act by requiring manufacturers of opioid drugs to ensure that certain information about the risk factors associated with opioid drugs are included on the drug labels.
The bill amends the Controlled Substances Act by: (1) addressing annual narcotic manufacturing quotas with respect to fentanyl, oxycodone, hydrocodone, oxymorphone, and hydromorphone; and (2) directing the Department of Justice (DOJ) to require medical practitioners to complete a training program on prescribing opioids for chronic pain before they are certified to prescribe controlled substances in schedule II, III, or IV.
The bill establishes requirements for prescription drug monitoring systems to prevent over-prescribing controlled substances.
The Department of Health and Human Services must: (1) submit a plan of action for addressing outliers in opioid prescribing practices and ensuring an adequate response to protect the public health, and (2) study the expansion of Medicare coverage for alternatives to opioid treatments.
The bill amends the Internal Revenue Code to impose an excise tax on manufacturers or producers of opioid pain relievers. A portion of the amount generated from the tax must be used for substance abuse treatment programs.
DOJ must establish a take-back program for the safe and environmentally responsible disposal of controlled substances.