Policy News Roundup: July 7, 2022

Key reads

FDA stays Juul's marketing denial order

Last month, the Food and Drug Administration (FDA) issued a marketing denial order banning Juul sales, but a federal appeals court temporarily blocked the ban the following day while the case was reviewed. This week, the FDA issued an administrative stay on the order, temporarily suspending the order while it conducts further review. The FDA said the stay and review do not “constitute authorization to market, sell or ship Juul products.”

Source: FDA temporarily lifts ban on Juul e-cigarettes while company appeals decision (CBS)

Stronger packaging regulations needed for copycat THC edibles

Partnership to End Addiction’s vice president of prevention research and analysis, Linda Richter, discusses the need to tighten inadequate packaging regulations that have allowed for THC products resembling famous candy and snack products that are appealing to children and lead young kids to ingest THC. A group of consumer packaged goods companies recently urged Congress to close loopholes that allow such packaging. The Food and Drug Administration issued a warning about the health threat to children posed by these products, and state attorneys general asked Congress to crack down on the copycat products. Policymakers should implement public awareness campaigns targeted to parents/caregivers, educators and health care professionals. States liberalizing marijuana laws should mandate strong child-resistant packaging requirements and require products be packaged and sold in small, nonfatal doses. They must clamp down on child-appealing packaging and marketing, and all products containing THC should be sold in plain, opaque packaging with clear warning labels.

Source: THC ingestion by young kids highlights the need to tighten inadequate packaging regulations (STAT)

NIH leaders call for addressing "preaddiction"

Tom McLellan, George Koob (National Institute on Alcohol Abuse and Alcoholism) and Nora Volkow (National Institute on Drug Abuse) explain the need for a clinical approach to addiction similar to that of the diabetes field, which increased treatment penetration and impact by identifying and intervening with early-stage diabetes, or prediabetes. The long latency from substance use to disorder offers an opportunity for clinical interventions to stop progression. Early-stage substance use is a pervasive, costly and serious public health risk in itself. Although those with mild to moderate substance use disorder comprise a larger proportion of the population and account for more substance use-related harm, treatment and public health efforts have focused almost exclusively on those with serious, chronic addictions. In order to implement an approach similar to that of prediabetes, integrated efforts will be required in measures to define and detect preaddiction; engaging, effective interventions for preaddiction; and public and clinical advocacy.

Source: Preaddiction—A Missing Concept for Treating Substance Use Disorders (JAMA)

Supreme Court rules that intent matters for prescribing to be criminal

The Supreme Court unanimously ruled that prosecutors need to prove that doctors knowingly prescribed medications in aberrant ways to convict them for unlawful distribution. Two doctors who were sentenced to decades in prison for unlawfully prescribing opioids brought the case and argued that they were acting in “good faith” to provide care. Doctors are allowed to prescribe controlled substances “for a legitimate medical purpose” in ways that fit with “the usual course of his professional practice.” The court found that intent matters for prescribing to be considered criminal, finding that the government must prove beyond a reasonable doubt that the defendant knew that they were acting in an unauthorized manner or intended to do so. The court told appeals courts to review the jury instructions from the original criminal cases against the two doctors to see if they comported with the new ruling.

Source: Supreme Court rules that doctors need to knowingly misprescribe opioids for it to be a crime (STAT)

Oklahoma reaches settlement with distributors

The Oklahoma attorney general announced a $250 million settlement with McKesson, Cardinal and AmerisourceBergen. The settlement must be approved by local government leaders. The money will be used to prevent and treat opioid addiction. Oklahoma was among a handful of states that did not join the $26 billion national settlement with the distributors. The distributors also recently announced a $75 million settlement with the Cherokee Nation. Oklahoma previously reached settlements with Purdue for $270 million, Teva for $85 million and Endo for $8.75 million. It also won a $465 million verdict against Johnson & Johnson in 2019, but the state Supreme Court tossed it in 2021, ruling that the state’ public nuisance law did not cover the fallout from addiction. Funding will be distributed through an Opioid Abatement Fund that will allocate proceeds to areas that need help most.

Source: Oklahoma reaches $250 million settlement with three companies that distributed opioids (The Oklahoman)

Judge rules in favor of distributors in West Virginia lawsuit

A federal judge ruled in favor of AmerisourceBergen, Cardinal and McKesson in a landmark lawsuit brought by Cabell County and Huntington, West Virginia. The verdict came nearly a year after closing arguments. The lawsuit alleged that the distributors created a public nuisance, but the judge said extending the law to cover opioid marketing/sale is “inconsistent with the history and traditional notions of nuisance.” He said the plaintiffs offered no evidence that the defendants distributed controlled substances to any entity that did not hold proper registration from the Drug Enforcement Administration or Board of Pharmacy, and that the companies had suspicious monitoring systems as required. The lawsuit was the first time allegations involving opioid distribution ended up at federal trial. A day after the ruling, another trial in a West Virginia lawsuit against the distributors was postponed. Attorneys who represented Cabell County and Huntington were granted a continuance of a trial in Kanawha County, which involves more than 100 other cities/counties. West Virginia was not part of the $26 billion nationwide settlement with the distributors.

Source: US judge finds for 3 drug distributors in WVa opioid lawsuit (Associated Press); After West Virginia opioid verdict, another case postponed (Associated Press)

CMS approves Vermont waiver including SUD programs

The Centers for Medicare and Medicaid Services approved an extension of Vermont’s Medicaid Section 1115 waiver demonstration. It will enable the state to continue to test, monitor and evaluate a managed care-like delivery system, home and community-based services and pilot programs. New initiatives include the Maternal Health and Treatment Services initiative, which will provide a whole-person and family-centered care model for treating pregnant people and mothers with mental health or substance use disorder. It will also establish the Substance Use Disorder (SUD) Community Intervention and Treatment eligibility group to increase access to SUD treatment services, such as counseling and residential treatment, for low- and moderate-income individuals with SUD.

Source: Vermont Global Commitment to Health Section 1115 Demonstration Extension Approval (Centers for Medicare and Medicaid Services)

Texas database helps track overdoses

The Texans Connecting Overdose Prevention Efforts (TxCOPE) database aims to improve overdose tracking. Community groups are using it to see where overdoses are spiking and target those spots with prevention efforts such as naloxone. There is no national count of how many people survive overdoses, and the Centers for Disease Control and Prevention does not have a standard method for states to count nonfatal overdoses. It aggregates overdose data from emergency room visits based on clinical/billing codes, but that excludes people who do not interact with the medical system. Additionally, fatal overdose data often lags. Other projects that count nonfatal overdose, such as ODMAP, rely on reports from law enforcement and first responders. But many people who use substances do not call emergency services or report overdoses for reasons including fear of arrest, deportation, loss of custody or loss of housing.

Source: Crowdsourced Data on Overdoses Pinpoints Where to Help (Kaiser Health News)

Mental health concerns and overdose deaths rising in adolescents

An issue brief on the state of adolescent mental health and substance use disorder found that overdose deaths among adolescents nearly doubled from 2019 to 2020 (from 282 to 546). The largest increases were among adolescent males (more than doubled), as well as Black (more than tripled) and Hispanic (more than doubled) adolescents. The brief also outlines data about other factors including anxiety and depression and adverse experiences. Access to mental health care may have worsened during the pandemic with declines in utilization of care among both Medicaid and private insurance pediatric beneficiaries. Reasons for not receiving care included costs and lack of providers.

Source: Recent Trends in Mental Health and Substance Use Concerns Among Adolescents (Kaiser Family Foundation)

McKinsey played large role in advising clients involved in the opioid crisis

A repository of more than 100,000 documents obtained by state attorneys general in the settlement with McKinsey revealed that the firm played a deeper and broader role in advising clients involved in the opioid crisis than was previously publicly disclosed. In addition to its already well-documented advising of Purdue, McKinsey advised the largest manufacturer of generic opioids, Mallinckrodt. McKinsey worked with Endo on marketing Opana and helped it grow into a leading generics manufacturer. The firm advised Johnson & Johnson, whose subsidiary Tasmanian Alkaloids was the largest supplier of the raw materials extracted from poppies used to make many top-selling opioids, and counseled government agencies on how to address the fallout when the full brunt of the crisis became apparent.

Source: Behind the Scenes, McKinsey Guided Companies at the Center of the Opioid Crisis (New York Times)

Parity needed in Medicare to improve access to mental health and addiction care

Legal Action Center and the Medicare Addiction Parity Project issued a report on the lack of parity in Medicare (the Mental Health Parity and Addiction Equity Act does not apply) and limits in mental health and substance use disorder care, urging Congress to apply the law to Medicare. It outlines how applying parity to Medicare would eliminate discriminatory limitations and improve care in Medicare Parts A and B and Parts C and D. Applying parity to Medicare will also help establish consistency across payers and prevent cost-shifting.

Source: The Path to Parity: Applying the Parity Act to Medicare to Improve Access to Substance Use Disorder and Mental Health Care (Legal Action Center)