Policy News Roundup: October 12, 2023

Key reads

Congress averts government shutdown but fails to renew SUPPORT Act

Despite averting a government shutdown, Congress let key health programs expire, including the SUPPORT Act, which funded opioid use disorder prevention, recovery and treatment. Lawmakers could try to reauthorize the programs in a potential spending deal ahead of the November 17 deadline to fund the government, but a specific path forward is not yet apparent. The House Judiciary Committee advanced its SUPPORT Act reauthorization bill several weeks ago with an amendment to schedule xylazine to Schedule III for three years as opposed to permanently, which the Energy and Commerce Committee’s version did. Funding for its programs will continue, but lawmakers must pass a reauthorization bill to make changes, like rescheduling xylazine. Some Medicaid plan options allowing for residential treatment for substance use disorder also expired, leaving states searching for funding elsewhere.

Source: Not such a ‘clean’ resolution (Politico)

FDA issues guidance to promote development of treatments for stimulant use disorders

The Food and Drug Administration (FDA) published new draft guidance to assist sponsors in developing treatments for stimulant use disorders. The guidance will be the first to provide the FDA’s current thinking on the overall development program and clinical trial design to develop drugs and biologics to support treatment of moderate to severe cocaine use disorder, methamphetamine use disorder and prescription stimulant use disorder. The guidance contains recommendations regarding clinical trial design related to evaluating stimulant use disorder treatments. It also describes basic considerations throughout the development process including trial conduct, data collection, methods to assess treatment response, subject safety and new drug application requirements. Comment is open for 60 days.

Source: FDA Takes Steps to Advance the Development of Novel Therapies for Stimulant Use Disorders (Food and Drug Administration)

DEA extends telehealth prescribing flexibilities through 2024

The Drug Enforcement Administration (DEA) said in a notice it would extend pandemic flexibilities allowing controlled substances to be prescribed via telemedicine through the end of 2024. The DEA said the temporary rule is meant to ensure a smooth transition for patients and practitioners who have come to rely on prescribing via telemedicine and allow adequate time for providers to come into compliance with any new standards. Controlled substances covered by the rule include stimulant medications for attention-deficit/hyperactivity disorder, anxiety medications and medications for opioid use disorder. In February, the DEA proposed new rules rolling back flexibilities before the public health emergency ended in May, but it faced immediate backlash and extended the flexibilities through November 11 before now extending them through 2024. The DEA said it is working to write new regulations by fall 2024.

Source: DEA extends pandemic telehealth rules for prescribing controlled substances (The Hill)

SAMHSA announces $35 million for behavioral health and HIV services

The Substance Abuse and Mental Health Services Administration awarded nearly $35 million to bring essential behavioral health services and HIV prevention and care to historically underserved populations. The awards include $21.9 million for a program to increase engagement in care for racial/ethnic medically underserved individuals with substance use disorder (SUD) and/or co-occurring mental health and substance use disorder at risk for or living with HIV; $10.5 million for a program that provides substance use and HIV prevention services to racial/ethnic minority populations at high risk for SUD and HIV infection, with an emphasis on LGBTQI+ persons who are not in stable housing and/or reside in communities with high rates of HIV, viral hepatitis or sexually transmitted infections; and $1.9 million for a program to provide comprehensive health care for racial/ethnic medically underserved people experiencing unsheltered homelessness through the delivery of portable clinical care delivered outside focused on the integration of behavioral health and HIV treatment and prevention services.

Source: SAMHSA Announces Nearly $35M in Grant Awards for Comprehensive Behavioral Health Care and HIV Prevention and Care for Historically Underserved Populations (Substance Abuse and Mental Health Services Administration)

Supreme Court to hear cases on agency authority and Purdue settlement

The Supreme Court is back for a new term with cases on the docket that could have ramifications for federal health officials and Purdue’s bankruptcy claim. Loper Bright Enterprises v. Raimondo is a major case for the regulatory authority of federal agencies. The case could overturn the Chevron doctrine, which holds that courts should defer to a federal agency’s reading of a vague statute as long as the interpretation is reasonable. Health care groups warned that could have a chilling effect on how the federal government can implement Medicare and Medicaid programs, for example. Over the summer, the Supreme Court put on hold a proposed bankruptcy settlement plan for Purdue and agreed to hold oral arguments in the case in December. The plan would have shielded the Sacklers, the family that owns Purdue, from future lawsuits. But the Department of Justice is challenging whether the Sacklers, who did not file for bankruptcy, can be spared from future litigation. Purdue has maintained optimism the justices will agree to the plan and framed the pause as delaying billions of dollars for opioid abatement.

Source: The Supreme Court cases we’re watching this term (The Washington Post)

FDA struggles to address illicit e-cigarettes

The latest flood of illicit e-cigarettes is arriving from China in fun colors and flavors following crackdowns on previously popular brands including Juul, Puff Bar and Elf Bar. The influx has exposed a lapse in enforcement by the Food and Drug Administration (FDA), which has authorized only a handful of the hundreds of options that line convenience store walls. Members of Congress, two dozen state attorneys general and even the Big Tobacco companies have stepped up calls for the FDA to control the situation. The pleas by the tobacco industry are viewed by antismoking groups as an effort to lock down market share. FDA officials said they had used every tool in their authority to crack down on e-cigarettes, but recent fines issued topped out at $19,000 per violation and targeted only a few products sold at each store. The FDA has fired off hundreds of warning letters, but the effect is barely felt.

Source: Illicit E-Cigarettes Flood Stores as F.D.A. Struggles to Combat Imports (The New York Times)

Democratic cities struggling with backlash to progressive harm reduction policies

Blue cities that have taken progressive steps to tackle the substance use crisis are beginning to question those strategies amid rising political backlash. Public health experts emphasize policies that prioritize saving lives, but the worsening crisis is testing the patience of even the seemingly most tolerant cities. Philadelphia’s City Council appears ready to override a veto of its ban on supervised consumption sites, San Francisco Mayor Breed proposed drug testing for welfare recipients and New York City is reeling from the suspected fatal fentanyl overdose of a one-year-old in day care. The cities are among those that have most embraced harm reduction. Other states, particularly those on the West Coast, have adopted measures that decriminalize drug possession and focus on treatment, but those efforts are being second-guessed. Meanwhile, dozens of states have enacted tougher fentanyl laws. Democrats are increasingly under pressure from constituents concerned about the crisis, and both parties are starting to come around to punitive positions. Experts say measures facing scrutiny are being unfairly blamed for the worsening problem. Overdoses and homelessness are up everywhere, not just in states that have implemented reforms, but also in states that have done nothing and in states that have passed tougher drug laws.

Source: Blue cities rethink their embrace of progressive drug policies (Axios)

Idaho AG says opioid settlement funds spent in recovery centers must be only for OUD

An opinion from the Idaho Attorney General’s Office says opioid settlement funds spent in recovery centers must go exclusively toward people with opioid use disorder. Idaho health officials say the opinion limits Idaho in ways different from other states and would make it difficult to fund recovery centers. Addiction experts say the opinion complicates the already difficult job of treating substance use, reducing access to care, particularly by requiring treatment centers to ask questions of people coming in for treatment. The recovery centers provide low barrier access to care, and making it harder to get care makes people less likely to receive services and makes treatment more expensive by adding more administration burden at intake. Other states and cities have a broader view of how the money should be spent, putting it toward substance use disorder generally or even for treatment of stimulant use.

Source: Legal opinion on opioid funds limits Idaho more than other states, health officials say (Idaho Capitol Sun)

Schools increasingly stock naloxone, but many are still resisting due to stigma

Since passage of a 2019 state law, Colorado has had a program that allows schools to obtain naloxone for free or at a reduced cost. Though more districts have signed on since last year, only about a third of school districts in the state were enrolled at the start of the school year. Within the dozen counties with the highest overdose death rates in the state, many had not signed up. The Substance Abuse and Mental Health Services Administration recommends that schools keep naloxone on hand, and 33 states have laws that expressly allow schools or school employees to carry, store or administer naloxone. Among those, about nine require at least some K-12 schools to store naloxone onsite. Some states also require that public schools offer training to students in how to administer naloxone. Rhode Island requires all K-12 schools to stock naloxone. Reluctance to stock naloxone can stem from officials being afraid to provide a medical service or the ongoing cost of resupplying and training. But the main hang-up is that schools are afraid they will be stigmatized as “bad schools.”

Source: More Schools Stock Overdose Reversal Meds, but Others Worry About Stigma (KFF Health News)

City leaders gather to develop a national strategy to address fentanyl

Last week, a summit of representatives from major cities focused on the fentanyl crisis was held in New York City to work towards a national strategy to combat fentanyl overdoses. Health care professionals, elected leaders and law enforcement officials from across the country shared best practices on education and prevention strategies, treatment, harm reduction, law enforcement, funding strategies and legislative action. Participants agreed on several action items to guide development of a national strategy to address the crisis. These include formalizing a multicity task force that will pilot innovative strategies; drafting a white paper outlining national best practices and opportunities; enhancing data-sharing on a national level; defining terms for cities across the nation to reduce stigma and standardize communication among policymakers, public health professionals, community-based organizations and other stakeholders; increasing collaboration and communication among key public health and public safety stakeholders; and identifying city, state and national funding and legislative needs to prevent overdose deaths and save lives.

Source: Mayor Adams Concludes Two-Day Summit on Fentanyl Crisis in America (NYC Office of the Mayor)

Mallinckrodt wins approval for bankruptcy plan cutting opioid settlement

Mallinckrodt won court approval for a bankruptcy plan that cuts $1 billion from what it must pay opioid crisis victims. Mallinckrodt first filed for bankruptcy in 2020 to address its high debt load, opioid litigation and disputes over its drug pricing. Despite that bankruptcy settlement resolving the litigation threats and cutting $1.5 billion in debt, Mallinckrodt found itself in financial trouble again and filed for a second bankruptcy. As part of the previous bankruptcy, Mallinckrodt agreed to pay $1.7 billion to settle about 3,000 lawsuits alleging it used deceptive marketing tactics to boost opioid sales. The new bankruptcy reduces that to $700 million, all of which has already been paid to a settlement trust. The company’s opioid creditors, including state and local governments, individuals and others who will seek payment from the settlement fund, supported the fast-track second bankruptcy, agreeing to accept a reduced amount as the best deal they could get given its financial woes.

Source: Court OKs Mallinckrodt restructuring, $1 billion cut to opioid settlement (Reuters)