WASHINGTON, D.C. – Today, Regina LaBelle, Acting Director of National Drug Control Policy, presented to Congress the Biden-Harris Administration’s recommendations for a long-term, consensus approach to reduce the supply and availability of illicitly manufactured fentanyl-related substances (FRS), while protecting civil rights and reducing barriers to scientific research for all Schedule I substances. The proposal, developed by the Office of National Drug Control Policy (ONDCP), the Department of Health and Human Services (HHS), and the Department of Justice (DOJ), is part of the Administration’s larger effort to address addiction and the overdose epidemic at a critical time when overdose deaths have reached a record high.

“By acting on these recommendations, Congress can take decisive action against the fastest growing driver of overdoses in the country, while protecting civil rights and encouraging scientific research,” said Acting Director LaBelle. “At the same time, it is critical for Congress to fund the President’s Budget request, which includes $10.7 billion to expand access to substance use prevention, treatment, harm reduction, and recovery support services.”

“Expanding the nation’s public health approach to substance use disorders is essential to our strategy to bringing down the rates of overdose death,” said Dr. Rachel L. Levine, Assistant Secretary for Health at the Department of Health and Human Services. “And while we continue to prioritize comprehensive, public health approaches, these recommendations can help address the increasing rates of drug overdose deaths, primarily those related to synthetic opioids like fentanyl analogs. We look forward to working with Congress to advance policies that will expand access and remove barriers to evidence-based treatment.”

“The permanent scheduling of all fentanyl related substances is critical to the safety and health of our communities,” said Anne Milgram, Administrator of the Drug Enforcement Administration (DEA). “Class-wide scheduling provides a vital tool to combat overdose deaths in the United States.”

Specifically, the Administration’s consensus approach includes the following recommendations to Congress:

  • Permanently place FRS into Schedule I of the CSA. This provides law enforcement with the tools they have said they need to respond to the trafficking and manufacture of illicitly manufactured synthetic opioids. Following the temporary class-wide scheduling of FRS in 2018, DEA National Forensic Laboratory Information System (NFLIS) data show that law enforcement encounters of fentanyl analogs that were not individually scheduled declined by almost 90%, when comparing total encounters from 2016 and 2017 to total encounters of uncontrolled fentanyl analogs from 2018 and 2019.
  • Exclude those FRS that are scheduled by class from all quantity-based mandatory minimum penalties (normally associated with domestic trafficking offenses of CSA Schedule I compounds). This proposal does not exempt FRS offenses from existing mandatory minimums for cases where death or serious bodily injury can be directly linked to the FRS that was trafficked, as is the case for any other Schedule I or II controlled substance under 21 U.S.C. 841(b)(1)(C). The Justice Department reported only eight cases with FRS charges from the time temporary class scheduling was adopted in 2018 through December 2020, of which only a handful even included charges of quantity-driven mandatory minimums.  
  • Create a streamlined process overseen by HHS to identify and remove or reschedule any individual FRS that is found to not have a high potential for abuse as defined in the CSA.
  • Ensures that a federal court can vacate or reduce the sentence of an individual convicted of an offense involving an individual FRS that is subsequently removed or rescheduled from Schedule I.
  • Establish a simplified process that would align research registration for all Schedule I substances, including FRS, more closely with the research registration process for Schedule II substances. The Biden-Harris Administration strongly supports expanding the research of Schedule I substances to help advance evidence-based public policy. For example, such research is critical in understanding FRS potential use for opioid addiction and overdose, chronic pain, and neurologic and psychiatric conditions, as well as its overall effects on human health. 
  • Direct the Government Accountability Office to analyze the implementation and impact of permanent class scheduling of FRS, including its impact on research, civil rights and the illicit manufacturing and trafficking of FRS.

Background:

The Centers for Disease Control (CDC) estimated that more than 93,000 people died of an overdose in 2020, and in recent years, the fastest growing driver of overdoses has been synthetic fentanyl.

On February 6, 2018, the Department of Justice issued a rule temporarily placing the class of FRS not otherwise scheduled into Schedule I of the Controlled Substances Act (CSA). On May 4, 2021, President Biden signed into law the Extending Temporary Emergency Scheduling of Fentanyl Analogues Act, which extended the temporary scheduling until October 22, 2021. The Administration committed to provide Congress with recommendations for a long-term approach.

For several months, officials from the ONDCP, DOJ, and the HHS met regularly to develop recommendations for a comprehensive, consensus approach that addresses the complex issues surrounding the scheduling of FRS. This process involved input from Congress, public health officials, law enforcement, and stakeholder groups.

These recommendations follow strategies outlined in the Biden-Harris Administration’s statement of first-year drug policy priorities to expand access to evidence-based prevention, treatment, harm reduction, and recovery support services, as well reduce the supply of illicit drugs.

The Biden-Harris Administration has also called on Congress for passage of the Eliminating a Quantifiably Unjust Application of the Law Act (EQUAL Act), a bill that would eliminate the current disparity in sentencing between crack cocaine and powder cocaine. The current disparity is not supported by the evidence and has caused significant harm for decades, particularly to communities of color.

The President’s FY2022 Budget proposal to Congress would advance the Administration’s public health-based approach to the overdose epidemic. It would provide a $41.0 billion investment for national drug program agencies, including $10.7 billion in the Department of Health and Human Services to expand access to substance use prevention, treatment, harm reduction, and recovery support services. Notably, the Substance Abuse and Mental Health Services Administration’s (SAMHSA) FY22 request includes $3.5 billion for the Substance Abuse Prevention and Treatment Block Grant, which for the first time includes a 10 percent set aside for recovery services.

In its first-year drug policy priorities, the Biden-Harris Administration outlined a strategy that includes expanding access to evidence-based prevention, treatment, harm reduction, and recovery support services, as well reducing the supply of illicit drugs. Since January, the Office of National Drug Control Policy has worked with other agencies across the government to advance President Biden’s drug policy priorities.

Among the actions taken by the Biden-Harris Administration are:

  • The American Rescue Plan invested nearly $4 billion to allow the Department of Health and Human Services’ (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) and Health Resources and Services Administration to expand access to vital mental health and substance use disorder services. The funding also included $30 million in supports for harm reduction services—a historic amount that will enhance proven interventions like syringe services programs that are safe, effective, and cost-saving.
  • HHS released the Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder, which exempt eligible health care providers from Federal certification requirements related to training, counseling and other ancillary services that are part of the process for obtaining a waiver to treat up to 30 patients with buprenorphine. This action expands access to evidence-based treatment by removing a critical barrier to buprenorphine prescribing.
  • The Drug Enforcement Administration (DEA) lifted a decade-long moratorium on opioid treatment programs that want to include a mobile component. This rule change will help provide treatment to rural and other underserved communities, including incarcerated individuals.
  • CDC and SAMHSA announced that Federal funding may now be used to purchase fentanyl test strips in an effort to help curb the dramatic spike in drug overdose deaths.
  • ONDCP designated six new counties as part of its HIDTA program. These counties in California, Illinois, Kentucky, and Pennsylvania will receive support for regional law enforcement efforts to disrupt and dismantle drug trafficking organizations.
  • ONDCP provided funding for the nationwide expansion of the HIDTA Overdose Response Strategy to all 50 states, Puerto Rico, the U.S. Virgin Islands, and the District of Columbia. The Strategy brings together drug intelligence officers and public health analysts at the local and regional level to share information and develop evidence-based intervention and support services that reduce overdoses.
  • ONDCP provided funding to support the establishment of state-level model legislation that advances efforts to expand access to harm reduction services, as well as promote equity in access to treatment and drug enforcement efforts for underserved communities.
  • ONDCP hosted more than 300 State, local, and Tribal leaders from all 50 States, Washington, D.C., American Samoa, Virgin Islands, Puerto Rico, and the Northern Mariana Islands for a virtual convening entitled “Opioid Litigation Settlement: Using Evidence to Lead Action.” At the convening, government officials, researchers, and experts discussed how State, local, and Tribal governments can use evidence and data to guide decisions about how funds from opioid litigation can be spent to address addiction and the overdose epidemic, while advancing equity.

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