Policy News Roundup: April 27, 2023

Key reads

Federal government has taken limited steps to guide opioid settlement funds

In 2020 and 2021, Biden set a plan to appoint an “opioid crisis accountability coordinator” to support states in opioid litigation. The White House convened a meeting about the settlements, noted the money could support drug policy priorities and created a model law for states. However, as funds now start to flow, there is no opioid crisis accountability coordinator, the Office of National Drug Control Policy has not released public statements about the settlements in over a year and the funds are mentioned just twice in the drug control strategy. The settlements require at least 85% be spent on opioid-related expenses, but interpretations vary. The administration can issue guidance and promote national research findings. The model law has been adopted, at least partially, by eleven states and is being considered by two others. The government could use the possibility of claiming repayment for opioid-related Medicaid expenses as leverage – in return for letting states keep the money, it could require it be spent on addressing the opioid crisis or only for research-backed treatments. It could attach conditions to grants to states and suggest funds be used to augment, not duplicate, existing funding, by going to grassroots organizations that do not have the time/ability to apply for federal grants or to groups that provide sterile syringes and other supplies that cannot be purchased with taxpayer dollars.

Source: Biden promised a watchdog for opioid settlement billions, but feds are quiet so far (NPR)

National Academies received millions from the Sacklers

The National Academies of Sciences, Engineering, and Medicine, which helped shape the federal response to the opioid crisis, accepted roughly $19 million in donations from the Sacklers. Unlike the WHO, which was accused of being manipulated by Purdue and retracted two opioid policy reports, NASEM has not conducted a public review to determine if the donations influenced its policymaking. A report released in 2011, now largely discredited, claimed that 100 million Americans suffered from chronic pain, a highly inflated estimate. It gave drugmakers a talking point for aggressive sales campaigns, primed doctors to prescribe more opioids, and influenced the Food and Drug Administration (FDA) to approve at least one opioid. In 2016, months after NASEM received a $10 million Sackler donation, the FDA tapped it to form a committee to issue recommendations on opioids. One senator took exception to members selected, complaining they had ties to opioid makers. Before work began, four were removed from the panel. NASEM says the donations were never used to support any advisory activities on opioids, and that it cannot return the money because of legal restrictions.

Source: Sacklers Gave Millions to Institution That Advises on Opioid Policy (The New York Times)

House GOP proposal to add work requirements in Medicaid would result in lost coverage

House Republicans’ bill to raise the debt ceiling would slash the budget back to FY 2022 levels, which would amount to $130 billion in cuts for 2024. The reductions probably would target health care, science, education, climate, energy, labor and research programs. The bill does not specify the exact agencies or programs to be cut. The bill would subject adults without children receiving SNAP to work requirements until age 56, up from 49 in current law. It would make it harder for states to exempt certain families, a flexibility some states use to help lower-income people during times of high unemployment. The bill proposes Medicaid work requirements, 80 hours per month of employment or community service. It includes beneficiaries 19-55, with some exceptions, including for those who are pregnant or caring for young children. A Department of Health and Human Services analysis found that the Medicaid work requirement proposal would jeopardize coverage for approximately 21 million. The Congressional Budget Office estimates that about 600,000 would become uninsured.

Source: House GOP unveils bill to cut spending, lift debt ceiling. Here’s how. (The Washington Post); New HHS Analysis: Congressional Republicans’ Medicaid Red Tape Would Jeopardize Health Coverage and Access to Care for 21 Million Americans If Implemented (Department of Health and Human Services); CBO: 600,000 more uninsured from House GOP bill (Axios)

FDA's opioid clinical trial faces criticism

A Food and Drug Administration (FDA) plan to study whether opioids are an effective chronic pain treatment is facing resistance from addiction and pain experts. Doctors and researchers argued that a planned clinical trial would not yield significant new information and may be biased in favor of opioids. In 2013, the FDA pledged to work with pharmaceutical manufacturers to conduct post-approval studies of prescription opioids on the market. Pharmaceutical companies formed the Opioid PMR Consortium to conduct the research. In the decade since, no such study has been conducted. The FDA’s most recent attempt, in 2019, was discontinued due to insufficient participants. The plan for the new trial has generated criticism that the format could lead to or worsen opioid dependence. Participants would be switched from current prescription opioids to extended-release morphine. A randomly selected subgroup would then be switched to a placebo, tapered off opioids over eight weeks. Experts criticized the eight-week taper, which could lead to significant withdrawal, and a focus on hyperalgesia (abnormally heightened sensitivity to pain) rather than more common harms like addiction.

Source: FDA’s new plan to study opioids’ effectiveness faces resistance (STAT)

ONDCP Director visits Philadelphia to discuss fentanyl and xylazine crises

Last week, Office of National Drug Control Policy Director Rahul Gupta visited Philadelphia to learn about the substance use challenges facing residents of the city and work being done to address them. Gupta met with city and state leaders to discuss the response to xylazine; academic and medical leaders to discuss expanding the use of buprenorphine to treat opioid use disorder; and state legislators about policies that would enhance Pennsylvania’s response to the crisis, including model state laws. He visited Kensington, an area of Philadelphia hard hit by xylazine. Gupta met with people on the front lines of the crisis, including local, state and federal law enforcement, harm reduction leaders and wound care specialists at Savage Sisters Recovery Wound Care Clinic. He also met with Mayor Kenney and visited the Curran-Fromhold Correctional Facility, where he saw their work to treat people who are incarcerated who have substance use disorder.

Source: In Philadelphia, ONDCP Director Meets with Leaders on the Front Lines of Fentanyl and Xylazine Crisis (Office of National Drug Control Policy)

Delaware legalizes recreational marijuana

Delaware Governor John Carney announced that he will allow HB 1 and HB 2 to be enacted into law without his signature. The bills remove all state-level civil and criminal penalties from simple marijuana possession and create a regulated industry for recreational marijuana sales. Carney supports medical marijuana and decriminalization, but he remains opposed to recreational legalization. However, he decided not to veto the legislation because he believes too much time has been spent on the issue. Carney said he remains concerned about the consequences of a recreational marijuana industry, especially about potential effects on children, roadway safety and poorer neighborhoods. He said as the state implements the bills, it will do everything in its power to protect children from accessing marijuana, prevent residents and visitors from driving under the influence of marijuana and closely evaluate the placement of dispensaries to ensure they do not become a blight on disadvantaged communities. None of up to 30 retail licenses will be issued until at least August 2024, while regulations are adopted.

Source: Governor Carney Releases Statement on House Bill 1 and House Bill 2 (Delaware News); No veto: Recreational marijuana will become legal in Delaware Sunday without Gov. Carney’s signature (WHYY)

San Francisco schools go to trial against Altria

The San Francisco school district’s trial against Altria, claiming it helped create a youth vaping crisis, began. The district also sued Juul, which settled last year. In opening statements, the district lawyer said Altria was “at the heart” of Juul’s strategy to grow its business by appealing to teens with sweet flavors and flashy advertising. He claimed Altria made a large investment in Juul after unsuccessfully trying to market its own e-cigarettes and knew Juul’s success was driven by youth. He said school staff now have to deal with rampant vaping in schools as a result. Altria’s lawyer claimed Juul sales fell after Altria’s investment, showing it could not be behind a surge in youth vaping, and noted the investment happened after Juul pulled most flavored products. She said a strategy targeting users under 18 would not make sense because Juul and Altria knew they would not get approval from the Food and Drug Administration if they marketed to teens.

Source: San Francisco schools take Altria to trial over ‘vaping crisis’ (Reuters)

Emergent to price OTC naloxone under $50

Emergent BioSolutions announced that over-the-counter (OTC) Narcan would be sold for “less than $50.” Advocates are concerned the price would put it out of reach for many people. Emergent said it needs to “foster a sustainable business model” and is taking a “responsible approach to pricing” that includes the costs of manufacturing, packaging and shipping. While individual retailers ultimately decide how much to charge per kit, the company said its goal is for the retail price to be “consistent with our public interest price.” The company has charged about $47 to local and state health departments, harm reduction groups and first responders who have handed out millions of doses in recent years. Injectable naloxone is far cheaper but has not been approved for OTC sales. Prices are likely to come down over time or if the Food and Drug Administration approves generic OTC versions of the nasal spray.

Source: Experts slam plan to sell overdose antidote Narcan at about $50 a kit (The Washington Post)

Limiting illicit xylazine while maintaining veterinarian access is a challenge

Addressing xylazine is a tricky balancing act involving diverse stakeholders. Law enforcement agents are pressing scheduling as a controlled substance, which would criminalize distribution for human use. Currently, police cannot arrest a person for sales/distribution of xylazine, and resources to track down its production are modest. Veterinarians fear this would limit their access. They would have to maintain separate logbooks for federal inspection. Production would require additional quality control and security measures so costly that manufacturers could raise prices or stop making it. Harm reduction groups fear criminal charges against people with addiction. A bipartisan bill proposes that sales/distribution for human use be subject to the same penalties as those for Schedule III substances, including fines up to $500,000 and a first-offense prison sentence of up to 10 years. It would require manufacturers to enhance record-keeping and send tracking reports to a federal database and would allow law enforcement to pursue dealers, but it would not subject vets to the restrictions of a controlled substance.

Source: The Fight Over a Drug That Is Great for Horses but Horrific for Humans (The New York Times)

Addiction affects decision-making, but providing skills and resources promotes recovery

Maia Szalavitz explains addiction’s complex effects on decision-making. As addiction escalates, craving intensifies even as the substances become less enjoyable, and people tend to prioritize short-term over long-term rewards. One theory suggests that despairing thoughts about oneself and the future, not thoughts about how good the substance is, predominate. Thoughts about negative consequences and alternative ways of coping are minimized. Risk factors like poverty, trauma and mental illness generate stress and negative thoughts about oneself. Factors linked to recovery, like social support and employment, can offset distorted thoughts and inflated valuation of substance use. People make better choices when they recognize and have access to better options. This is why punitive approaches so often backfire – causing more pain to people who view substances as their only way to cope drives desire to use even more. Providing people with skills and resources they need to change can promote recovery.

Source: Is There Still Free Will in Addiction? (The New York Times)

Involuntary treatment more likely to harm than help

Sarah Wakeman explains that while support for involuntary treatment is frequently rooted in compassion and desperation, forced treatment likely does more harm than good. Massachusetts Section 35 allows a judge to issue a warrant for an individual deemed at imminent risk of harm from substance use, who is then picked up by police. Men can be taken to correctional facilities and held against their will for up to 90 days. Even under ideal care, the experience is traumatic. Data shows rapid recurrence of opioid use and high risk of fatal overdose after release from compulsory treatment and corrections. Drug courts often mandate treatment to people without addiction who are arrested on drug-related charges and then fail to provide quality care to those who need it. Addiction is defined by using substances despite negative consequences, and substance use is a powerful coping mechanism, so making someone’s life worse is not going to help them get well. Huge numbers of people want treatment and are not able to access it. Money should go toward evidence-based models (voluntary, low-barrier treatment), rather than prison cells.

Source: Why involuntary treatment for addiction is a dangerous idea (STAT)