Committee Leaders Release Discussion Draft of Bipartisan Legislation to Address Urgent Opioid Crisis

Proposals are the result of 6 bipartisan hearings on opioid crisis with FDA, NIH, CDC, SAMHSA, governors, experts, and families

WASHINGTON, April 4, 2018 — The leaders of the Senate health committee today released a discussion draft of bipartisan legislation to address the opioid crisis. The leaders also announced that a committee hearing on the draft legislation will take place on Wednesday, April 11th.

The Opioid Crisis Response Act of 2018 will improve the ability of the Departments of Education, Labor, and Health and Human Services (HHS), including the Food and Drug Administration (FDA), the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), the Health Resources and Service Administration (HRSA), and the Substance Abuse and Mental Health Services Administration (SAMHSA), to address the crisis, including the ripple effects of the crisis on children, families, and communities, and improve data sharing between states. This discussion draft is the result of months of hearings as well as input and language from Senators on both sides of the aisle.

Senate health committee Chairman Lamar Alexander (R-Tenn.) said: “The opioid crisis is currently our most serious public health epidemic and despite efforts in every state, it’s getting worse. Our response needs to be urgent, bipartisan and effective. We’ve been listening to the experts for the last six months on how the federal government can help states and communities bring an end to the opioid crisis, and the bipartisan proposals in this draft reflect what we’ve learned, including: spurring the development of a non-addictive painkiller, giving the FDA authority to require drug manufacturers to package certain opioids for a set duration, and require manufacturers to give patients simple and safe ways to dispose of unused opioids, improving the detection and seizure of illegal drugs, including fentanyl, and improving data sharing so doctors and pharmacies can know if patients have a history of substance abuse and states can better track opioid prescriptions.”

Senate health committee Ranking Member Patty Murray (D-Wash.) said: “Families and communities have demanded, and they deserve, additional serious federal action to support and strengthen their efforts on the frontlines of the opioid crisis. By working together, listening to researchers, officials, experts, and families facing the crisis, and pulling in the ideas of Senators from both sides of the aisle—we have been able to take an important step with this draft bill toward addressing the wide set of challenges caused by the opioid epidemic. I look forward to getting input on this discussion draft and am hopeful that we can continue working together to get this bill signed into law as an important step forward in our work to tackle this national crisis.”

Alexander and Murray have held a series of six hearings so far this Congress to examine ways the federal government can be a better partner for states and communities on the front lines of the opioid crisis.

On October 5, 2017, the Senate health committee held the first hearing of the series which focused on the federal response to the opioid crisis, and on November 30, 2017, the committee heard from witnesses representing states, communities, and providers on what they are doing and what, if any, new authorities they need from the federal government to fight the crisis. On January 9, 2018, the committee heard from author Sam Quinones, who has extensively researched and written about the opioid crisis. On February 8, 2018, the committee held a hearing focused on listening to the needs of children and families affected by the opioid crisis. On February 27, 2018, the committee held a hearing on the role technology and data play in responding to the crisis. On March 8, the committee heard from some of the nation’s governors about how they are coming up with innovative solutions and leading the fight against the unique problems their states face in the midst of the opioid crisis.

Alexander has said that his goal is for the committee to markup opioids legislation this spring.

The 21st Century Cures Act, sponsored by Alexander and Murray and passed in December 2016, included provisions to advance biomedical research and speed the development of new, safe and effective treatments and cures for patients, and provided $1 billion for state opioid prevention and treatment efforts.

The Opioid Crisis Response Act of 2018 will:

  • Spur development of non-addictive painkillers, and other strategies to prevent, treat, and manage pain and substance use disorders through additional flexibility for the NIH and clarifying guidance from the FDA.
  • Encourage responsible prescribing behavior by clarifying FDA authority to require packaging 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.
  • Clarify FDA authorities to require manufacturers to give patients simple and safe options to dispose of unused opioids.
  • Improve detection and seizure of illegal drugs, such as fentanyl, through stronger FDA and Customer Border Protection coordination.
  • Clarify FDA’s development and regulatory pathways for medical product manufacturers through guidance for new non-addictive and non-opioid pain products.
  • 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 to substance use disorder treatment 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.
  • Update Drug Enforcement Administration regulations to improve treatment access for patients in rural and underserved areas through telemedicine, while maintaining proper safeguards.
  • Allow hospice programs to safely and properly dispose of unneeded controlled substances to help reduce the risk of diversion and misuse.

Click here for the text of the discussion draft, and here for a summary.

The Committee requests comments on the draft legislation from interested stakeholders by April 11th, 2018 at HelpFightsOpioids@help.senate.gov.


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