AAOS May 1, 2018
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Congress Moves Opioid Legislation

The Senate health committee last week voted to approve the Opioid Crisis Response Act of 2018, which Chairman Lamar Alexander (R-Tenn.) said will “help create an environment for states to succeed in fighting the opioid crisis.”

“Over the last six months, this committee has heard from experts on how the federal government can be the best possible partner as we work to combat the nation’s largest public health crisis – the opioid crisis,” Alexander said. The challenge before us has often been described as needing a moonshot. Solving the opioid crisis might require the energy and resources of a moonshot, but ultimately it is not something that can be solved by an agency in Washington, D.C.”

The Opioid Crisis Response Act of 2018 will:

  • Reauthorize and improve grants to states and Indian tribes for prevention, response, and treatment to mitigate the opioid crisis, authorized in 21st Century Cures, for three more years.
  • Spur development and research of non-addictive painkillers, and other strategies to prevent, treat, and manage pain and substance use disorders through additional flexibility for the NIH.
  • Clarify FDA’s regulatory pathways for medical product manufacturers through guidance for new non-addictive pain and addiction products.
  • Encourage responsible prescribing behavior by clarifying FDA authority to require packaging and disposal options for certain drugs, such as opioids to allow a set treatment duration—for example “blister packs,” for patients who may only need a 3 or 7 day supply of opioids—and give patients safe disposal options.
  • Improve detection and seizure of illegal drugs, such as fentanyl, through stronger FDA and Customs and Border Protection coordination.
  • Clarify US Customs and Border Protection is responsible for destroying controlled substances found in packages at the border, and strengthen FDA’s authority to refuse admission of illegal drugs from bad-actors. 
  • Clarify FDA’s post-market authorities for drugs, such as opioids, which may have reduced efficacy over time, by modifying the definition of an adverse drug experience to include such situations.
  • Provide support for states to improve their Prescription Drug Monitoring Programs (PDMPs) and encourage data sharing between states so doctors and pharmacies can know if patients have a history of substance misuse.
  • Strengthen the health care workforce to increase access to mental health services in schools and community-based settings and to substance use disorder services in underserved areas.  
  • Authorize CDC’s work to combat the opioid crisis, including providing grants for states, localities, and tribes to collect data and implement key prevention strategies. 
  • Address the effects of the opioids crisis on infants, children, and families, including by helping states improve plans of safe care for infants born with neonatal abstinence syndrome and helping to address child and youth trauma. 
  • Authorize the Department of Labor to address the economic and workforce impacts for communities affected by the opioid crisis, through grants targeted at workforce shortages for the substance use and mental health treatment workforce, and to align job training and treatment services.
  • Improves treatment access to patients by requiring the Drug Enforcement Administration to issue regulations on how qualified providers can prescribe controlled substances in limited circumstances via telemedicine.  
  • Allow hospice programs to safely and properly dispose of unneeded controlled substances to help reduce the risk of diversion and misuse.

Similarly, the House Energy and Commerce Committee is considering more than 60 separate bills that address painkillers and substance abuse. The American Association of Orthopaedic Surgeons (AAOS) sent letters to ranking members of both committees commenting on the various legislative proposals.

“To be successful, stakeholders need to work together to ensure all patients have access to the whole
gamut of options that prevent and treat addiction,” the AAOS letter states. “The AAOS supports increased access to evidence-based pain related treatment, including mental health and substance abuse treatment, research into innovative treatments, better prescription monitoring, and effective education for physicians and patients. To these ends, the AAOS is working on several initiatives – from public service announcements to a ‘pain relief toolkit’ – to encourage AAOS members to practice safe and effective pain management and treatment.”

Read the letter to the Senate Committee on Health, Education, Labor and Pensions (PDF)…

Read the letter to the House Energy and Commerce Committee (PDF)…

Find all AAOS advocacy resources on opioids at https://www.aaos.org/Advocacy/FDA/.