Policy News Roundup: May 9, 2024

Key reads

SAMHSA announces $1.5 billion in opioid grants

The Substance Abuse and Mental Health Services Administration announced the 2024 State Opioid Response (SOR) and Tribal Opioid Response (TOR) Grants, providing up to $1.48 billion to states, territories and D.C. and $63 million to Tribes to address the overdose crisis. The funding opportunity includes initiatives to expand naloxone distribution; enhance the full continuum of services for transitional aged young people (16-25); expand access to medications for opioid use disorder (MOUD) in correctional settings; and emphasize a whole-person approach to care. SOR awards will be extended from 2 to 3 years, and TOR awards from 2 to 5 years. From 2018 to 2023, SOR recipients reported over 550,000 overdose reversals; about 9.8 million naloxone kits and 7 million fentanyl test strips distributed; and over 1.2 million people receiving treatment services and over 600,000 receiving MOUD. TOR awards have provided treatment and recovery support to over 11,000 people, distributed almost 50,000 naloxone kits and 37,000 fentanyl test strips and furnished prevention resources to over 78,000 people.

Source: Biden-Harris Administration Announces Critical More Than $1.5 Billion State and Tribal Opioid Response Funding Opportunities (Substance Abuse and Mental Health Services Administration)

More than 320,000 children lost a parent to overdose 2011-2021

A study by researchers at federal agencies found that from 2011 to 2021, an estimated 321,566 U.S. children lost a parent aged 18-64 to drug overdose. The rate of children who lost a parent to overdose increased from 27 per 100,000 children in 2011 to 63.1 in 2021. The highest rates were among children of non-Hispanic American Indian/Alaska Native individuals, who had more than double the rate among children of non-Hispanic White and non-Hispanic Black individuals. While rates increased consistently each year for all parental age, sex and race/ethnicity groups, non-Hispanic Black parents aged 18-25 had the largest average annual percentage change. Rates increased for both fathers and mothers, but more children lost fathers. Responses to the overdose crisis should account for the full burden of overdose on families and children, including the economic, social, educational and health care needs of children who have lost parents to overdose.

Source: Estimated Number of Children Who Lost a Parent to Drug Overdose in the US From 2011 to 2021 (JAMA)

FDA issues e-cigarette warning letters

The Food and Drug Administration issued warning letters to 14 online retailers for selling unauthorized e-cigarette products popular among youth. The letters cite the sale of disposable e-cigarette products marketed under popular brand names such as Elf Bar/EB Design, Esco Bars, Funky Republic, Hyde, Kang, Cali Bars and Lost Mary. Letter recipients have 15 working days to respond with the steps they will take to address the violations and to prevent future violations.

Source: FDA Issues Warning Letters to 14 Online Retailers for Selling Unauthorized E-Cigarettes (Food and Drug Administration)

Endo ordered to pay $1.5 billion in fines related to Opana ER marketing

The Department of Justice ordered Endo Health Solutions Inc. to pay $1.5 billion in criminal penalties for violations of the Federal Food, Drug, and Cosmetic Act related to distribution of the opioid Opana ER. It is the second largest set of criminal financial penalties ever levied against a pharmaceutical company. The company pleaded guilty to one misdemeanor count of introducing misbranded drugs into interstate commerce. Endo admitted that from 2012-2013, certain sales representatives marketed Opana ER to prescribers by promoting its purported tamper or crush resistance and abuse deterrence, despite a lack of clinical data supporting those claims. The company pulled the drug from the market in 2017. The company has also agreed to a bankruptcy settlement.

Source: Opioid Manufacturer Endo Health Solutions Inc. Ordered to Pay $1.536B In Criminal Fines and Forfeiture for Distributing Misbranded Opioid Medication (Department of Justice)

NIDA trial shows starting naltrexone faster can be effective

A National Institute on Drug Abuse clinical trial found that starting people with opioid use disorder on extended-release, injectable naltrexone within 5-7 days of seeking treatment is more effective than the standard 10-15 days but requires closer medical supervision. This rapid treatment protocol could make extended-release naltrexone more viable as a treatment option. Starting extended-release naltrexone has traditionally required patients to go through a 7-10-day opioid-free period to avoid painful withdrawal symptoms caused when naltrexone abruptly stops the effects of opioids in the brain. During this period, however, patients are at high risk of returning to opioid use or discontinuing treatment. In the trial, patients on the rapid procedure were significantly more likely to receive the first injection of naltrexone, and withdrawal severity was generally low and comparable across the groups. Targeted safety events and serious adverse events were infrequent but occurred more on rapid procedure, and the rapid procedure required more staff attention.

Source: Faster approach for starting extended-release naltrexone to treat opioid use disorder shown effective (National Institute on Drug Abuse)

SAMHSA announces nearly $47 million in behavioral health funding

The Substance Abuse and Mental Health Services Administration announced $46.8 million in notices of funding opportunities to promote youth mental health, grow the behavioral health workforce, improve access to culturally competent behavioral care across the country and strengthen peer recovery and recovery support. This includes $15.4 million for the Minority Fellowship Program; $14.9 million for Cooperative Agreements for the Garrett Lee Smith State/Tribal Youth Suicide Prevention and Early Intervention Programs; $9 million for Addiction Technology Transfer Centers Cooperative Agreements; and $7.5 million for the National Center for Mental Health Dissemination, Implementation and Sustainment Cooperative Agreement.

Source: Biden-Harris Administration Announces $46.8 Million in Behavioral Health Funding Opportunities to advance President Biden’s Unity Agenda as Part of May Mental Health Awareness Month (Substance Abuse and Mental Health Services Administration)

Despite permanent methadone flexibilities, some states are slow to expand access

Pandemic regulations allowed states to give more methadone patients up to 28 days of take-home doses. In February, the Substance Abuse and Mental Health Services Administration (SAMHSA) made these rules permanent, and they went into effect last month. Opioid treatment programs (OTPs) have until October to comply. But there is concern that states that did not preserve the relaxed regulations they had during the pandemic might be slow to adopt them now. Later this month, SAMHSA will convene a meeting of regulators from all 50 states to discuss the new federal rules and how states might bring their own standards into compliance. At least 10 states had “stability criteria” for take-home doses that were stricter than federal rules as of June 2021. Individual OTPs might be even more restrictive. Some state legislatures are working on legislation to bring states’ rules in line with the federal rules, while other states issued executive orders adopting many of the federal guidelines. But other states have not yet followed suit.

Source: More addiction patients can take methadone at home, but some states lag behind (Stateline)

States announce settlement with Amneal Pharmaceuticals

In a nationwide settlement with state attorneys general, opioid manufacturer Amneal Pharmaceuticals will be required to pay up to $272.5 million nationally to address its role in the opioid crisis. The attorneys general allege that the company failed to properly monitor and report suspicious opioid orders. The settlement, if completed, would provide up to $92.5 million in cash and $180 million in opioid overdose reversal products.

Source: Attorney General Bonta Announces $273 Million Nationwide Agreement with Amneal Pharmaceuticals for its Role in the Opioid Epidemic (Rob Bonta)

Tobacco lobbyists in statehouses increase amid flood of tobacco and vaping legislation

A new report found that around the country, statehouses are being flooded with tobacco industry lobbyists. There are now at least 950 lobbyists representing cigarette, vape and snus companies in statehouses around the country. The number of lobbying registrations tied to tobacco companies jumped over 10% between 2023 and 2024. The tally is likely an undercount because several states only require lobbying firms, not individual lobbyists, to register with the state. Pennsylvania, Florida and Ohio have the largest number of lobbyists. The number of statehouse lobbyists on tobacco company payrolls is a testament to the amount of smoking- and vaping-centric legislation moving through statehouses. This includes bills that would help clear the market of illegal flavored vapes, task the state with compiling its own registry of Food and Drug Administration-approved vaping products or impact local governments’ ability to set their own tobacco laws (e.g., flavor bans).

Source: Statehouses are a hotbed of tobacco lobbying and legislation (STAT)

Wisconsin lawmakers approve new plan for opioid settlement funds

Republican lawmakers on the Wisconsin legislature’s budget committee rewrote the spending plan for the state’s next allotment of opioid settlement money, throwing out items the Department of Health Services (DHS) pushed for and instead boosting spending on existing programs. DHS’s proposal for the $36 million the state will receive in 2025 would have included $5 million for support/resource centers for families of people with opioid use disorder (OUD) and $5 million for peer support services in OUD programs, both omitted by the committee’s plan. The committee plan reduces spending on community, education and after-school prevention to $3.5 million from the proposed $5 million. The revised plan adds $750,000 for public campaigns to discourage opioid use, increases spending on harm reduction (e.g., naloxone, fentanyl test strips) to $6 million and allocates $3 million for law enforcement agencies, tripling DHS’s proposal. It allocates $7.7 million for building projects, more than double what DHS proposed, $2.75 million to cover room and board for Medicaid patients in residential treatment, $3 million for medications for OUD and $600,000 for a program that provides care before and after birth to women with OUD.

Source: Lawmakers agree on opioid plan, remain deadlocked on PFAS, hospital funds (Wisconsin Examiner)

Canada rolls back decriminalization of public drug use in British Columbia

The government of Canada yesterday walked back part of the three-year pilot program allowing people in British Columbia to possess small amounts of drugs without fear of criminal charges. At the request of the province and after a public backlash, people in British Columbia are no longer permitted to use drugs in public places. Under the changes, which went into effect immediately, adults will still be allowed to possess small amounts of drugs, but they will now have to use them in legal residences, at safe injection sites and at other harm reduction centers established by health authorities. The move underscores the difficulties governments are facing in addressing the opioid crisis, even in a province that has been a global pioneer in harm reduction. The use of drugs in public has long been a fact of life in parts of British Columbia, particularly Vancouver. Complaints about it have fallen since the start of the decriminalization pilot program, but public use appears to have spread beyond the neighborhoods where it was most common before decriminalization.

Source: Canada Re-Criminalizes Public Drug Use in British Columbia (The New York Times)