March 01, 2016

Manchin Introduces Five Amendments to Improve Comprehensive Opioid Legislation

Washington D.C. – Today U.S. Senator Joe Manchin (D-WV) introduced five amendments to the Comprehensive Addiction and Recovery Act of 2015 (CARA), bipartisan legislation to address the opioid epidemic nationwide. His amendments improve this legislation by raising funding for substance abuse treatment, changing the culture at the Food and Drug Administration (FDA), requiring the FDA to seek advice of its advisory committee before approving any new opioid medication, making prescriber education mandatory, and providing funding to strengthen consumer education.

“The Comprehensive Addiction and Recovery Act of 2015 is a solid start in launching a broad effort to combat our nation’s opioid epidemic, yet additional steps must be taken to ensure that the federal government’s approach to this tragic trend is sufficiently comprehensive,” Senator Manchin said. “My five amendments will strengthen this bill by providing real resources to combat this epidemic, as well as arming those on the front lines of this fight with the information and resources they need to combat this epidemic.”

Below is a list of Senator Manchin’s amendments:

Mandatory Prescriber Education - Requires medical practitioners to receive training on the safe prescribing of opioids prior to receiving and renewing their DEA registration to prescribe controlled substances. The training must be approved by the Secretary of HHS and include information on safe opioid prescribing guidelines, the risks of over-prescribing opioid medications, pain management, early detection of opioid addiction, and the treatment of opioid-dependent patients.

Consumer Education - This amendment would establish consumer education grants through SAMHSA to raise awareness about the risks of opioid addiction and overdose. Authorizes $15 million per year for 5 years.

Changing the Culture of the FDA Act - This amendment would amend the FDA’s mission statement to include language that would require the agency to take into account the public health impact of the nation’s opioid epidemic when approving and regulating opioid medications.

FDA Accountability for Public Safety Act - This amendment would require the FDA to seek the advice of its advisory committee before approving any new opioid medication. If the FDA approved the drug against the advice of the advisory committee, the agency would be required to submit a report to Congress justifying the decision. The approval is delayed until this report is submitted.

Raising funding for substance abuse treatment - Establish a 1 cent fee on each milligram of active opioid ingredient in a prescription pain pill to be paid by the manufacturer or importer. The funds raised would be used to pay for efforts to provide and/or expand access to substance abuse treatment and would be distributed as part of the Substance Abuse Prevention and Treatment Block Grant. There is a rebate for opioids prescribed for cancer related pain and hospice patients and an exemption for opioids used as part of medically assisted treatment.