Juul agreed to pay North Carolina $40 million to settle a lawsuit claiming the company’s marketing practices fueled widespread addiction among young people. In the agreement, Juul denies wrongdoing or liability. The agreement requires Juul to sell its products only behind the counter in the state and to use third-party age verification for online sales, commits Juul to sending teenage “mystery shoppers” to stores to check whether they are selling to minors, bars the company from using models under age 35 in ads, states that no ads should be posted near schools and imposes other restrictions to protect youth. Thirteen states and Washington, D.C. have filed similar lawsuits, and a group of 39 Attorneys General have been investigating Juul’s marketing and sales practices, as has the FDA. The FTC is suing Juul and Altria for violating antitrust laws, and there is multidistrict litigation consolidating personal injury, consumer class action and government entity cases. The North Carolina settlement is seen as a bellwether for future settlements, though $40 million may not be enough to prevent future wrongdoing. Juul is trying to shed its reputation as the company that fueled the youth vaping epidemic by appearing to take responsibility for its actions, but some feel that its early marketing missteps, popularity among teens and relationship with Big Tobacco could make it difficult for Juul to come across as a responsible company. Juul is also trying to persuade the FDA to allow it to continue sales in the U.S., as the FDA reviews whether Juul’s products have enough public health benefit as a safer alternative for smokers to stay on the market, despite their popularity among youth. Juul settled with North Carolina in part to avoid courtroom testimony from parents and teens during the FDA review.
Source: Juul to Pay $40 Million to Settle N.C. Vaping Case (New York Times); North Carolina’s settlement with Juul doesn’t go far enough for one major anti-vaping advocate (STAT); Juul is Paying $40 Million to Rebuild Its Reputation. Will It Work? (TIME); Juul Is Fighting to Keep Its E-Cigarettes on the U.S. Market (New York Times)
In an article for Filter, Partnership to End Addiction’s Emily Feinstein, former ONDCP Deputy Director Tom McLellan and Legal Action Center’s Paul Samuels write about the need for the federal government to take the same kind of urgent action to stem overdose deaths as it has to address COVID-19. As soon as the FDA approved the COVID-19 vaccines, there was immediate mobilization and collaboration to distribute them, and messaging has been clear and consistent. According to the authors, the same coordinated response is needed for medications for opioid use disorder, which are the gold-standard of treatment but are underutilized due to policy barriers and stigma. They argue that inadequate funding has led to a lack of treatment centers offering medications for opioid use disorder (MOUD) and clinicians trained to screen or treat OUD, and that reimbursement rates are insufficient. A high-profile, coordinated campaign is needed to reduce substance use disorder and overdose, along with increased funding for treatment, prevention, harm reduction and recovery supports; increased training for health care professionals; sufficient reimbursement rates; removal of insurance barriers; and public education campaigns.
Source: We Must Address the Overdose Crisis With the Same Focus as COVID-19 (Filter)
The Drug Enforcement Administration (DEA) published a final rule to authorize DEA registrants authorized to dispense methadone for opioid use disorder to add a mobile component to their existing registration, eliminating the separate registration requirement for mobile narcotic treatment programs. This will streamline the registration process and make it easier for registrants to provide needed services in remote or underserved areas.
Source: DEA Finalizes Measures to Expand Medication-Assisted Treatment (Drug Enforcement Administration)
The Office of National Drug Control Policy (ONDCP) awarded more than $3.2 million to 65 communities nationwide for its Community-Based Coalition Enhancement Grants to Address Local Drug Crisis (CARA) Program. The funding will enhance the efforts of current or former Drug-Free Communities program recipients to prevent opioid, methamphetamine and prescription drug use among youth ages 12 to 18. The program is a partnership between the ONDCP and the National Center for Injury Prevention and Control at CDC and aims to reduce youth substance use by providing funding to local coalitions to help them apply evidence-based prevention strategies to the emerging challenges in their communities.
Source: ONDCP Announces $3.25 Million for Local Coalitions Across the Country Working to Reduce Youth Substance Use (White House Office of National Drug Control Policy)
Miriam Delphin-Rittmon and Anne Milgram both received Senate confirmation and were sworn in as Assistant Secretary for Mental Health and Substance Use and DEA Administrator, respectively.
Source: 2 High-Ranking HHS Nominees Sail Through Senate Confirmation (Bloomberg); Anne Milgram Sworn In As DEA Administrator (Drug Enforcement Administration)
New York’s opioid trial began last week. The trial is the first to target the entire supply chain and the first in which a jury rather than a judge will decide the outcome. In the days leading up to the trial, pharmacy chains that were originally included (Walmart, CVS, Rite Aid and Walgreens) were removed following settlements. Purdue was also originally named, but its bankruptcy filing paused cases against it. Johnson & Johnson settled last week, agreeing to pay $230 million over nine years and to stop selling opioids nationwide but not admitting liability or wrongdoing. Companies including Teva, Endo, Allergan, Cardinal Health, AmerisourceBergen and McKesson will still take the stand, defending against claims that they created a public nuisance in the opioid crisis that they are financially responsible for fixing. Jurors will be asked to determine which defendants are liable, but damages would be assessed in a second trial. In opening arguments, lawyers for New York State and Suffolk and Nassau Counties said the defendants are responsible for the public nuisance of addiction, deaths and other harms caused by flooding communities with opioids, and that they turned a “blind eye” to the dangers posed by opioids. Drug companies and distributors fought back against these allegations and urged jurors to examine each defendant’s alleged actions and refrain from looking at them as a monolith. Any money received from settlements will go to an Opioid Settlement Fund created by a law Governor Cuomo signed this week. This will ensure the funds are used for substance use disorder treatment, prevention and recovery programs.
Source: An Opioid Case Like No Other: N.Y. vs. the Supply Chain (New York Times); Johnson & Johnson reaches $230 million opioid settlement with New York (NBC); Major Trial Against Opioid Suppliers Begins in New York (New York Times); Drug companies, distributors hit back at state, counties in opioid trial (Politico); Cuomo signs Opioid Settlement Fund bill as major manufacturer trial begins (Lohud)
Democratic Wisconsin Governor Tony Evers signed a bill that spells out how a potential opioid settlement would be divvied up between the state and counties, over the objections of Attorney General Josh Kaul. Kaul said the bill does not cap attorney’s fees and gives the Republican-controlled budget committee even more authority over lawsuit settlements than it now has. Gov. Evers told lawmakers he was signing the bill but was deeply troubled by several provisions that he said were unconstitutional because they violate separation of powers between the executive branch and the legislature, which would have the authority to approve any opioid deals reached by the state. Such powers have been in place since former Republican Gov. Scott Walker signed them into law. Evers said despite his concerns, he is not willing to risk maximizing settlement dollars by vetoing the bill in its entirety. Under the new law, 70% of the funds would go to counties and local governments and 30% to the state’s Department of Health Services.
Source: Evers Signs Bill Giving Portion of Potential Settlement To Local Governments (Wisconsin Public Radio)
The D.C. Council voted to ban the sale of flavored tobacco products, including menthol cigarettes. Some legislators raised concerns that the law would create opportunities for Black smokers to be harassed by police and that the city would be unfairly targeting a smoking choice preferred by Black residents. The legislation now heads to Mayor Muriel Bowser, who is expected to sign it. D.C. joins Massachusetts along with some other cities in banning menthol cigarettes alongside other flavored tobacco products, and the Biden administration has vowed to do the same. The D.C. bill bans the sale of the products but does not criminalize an individual’s smoking of a cigarette. In an attempt to avoid police interactions based on the use of flavored tobacco, the council approved a change to the bill saying that the law does not give city police the authority to act on their own to enforce the ban. The Department of Consumer and Regulatory Affairs, which can inspect stores to make sure they are not selling flavored tobacco, could still call in police for assistance.
Source: D.C. Council votes to ban sale of flavored tobacco, including menthol cigarettes (Washington Post)
A pair of policy briefs examines the landscape of state cannabis laws and the population health impacts of cannabis legalization. The briefs identify four overarching categories of state cannabis policies: prohibition of all supply, decriminalization, legalization for medical purposes and legalization for recreational purposes. The authors argue that evidence of the effects of cannabis liberalization on population health is limited and inconsistent, with research suggesting that cannabis use is associated with potential therapeutic benefits but also individual health harms, particularly for adolescents. Consequently, the briefs state, policymakers should incorporate a public health perspective in the design of legal cannabis markets, including suggestions based on lessons learned from tobacco and alcohol policy and recommendations that focus on youth cannabis use. The authors argue that policymakers should also adopt a public health-informed approach that addresses inconsistencies between federal and state law, offers regulatory oversight to improve the safety of cannabis supply, and combats inequities arising from the war on drugs and from disparities in access to newly legal supply chains. The briefs state that future research should assess heterogeneous policy design, differential effects on subgroups, and effects related to characteristics of legal cannabis supply, such as price and potency.
Source: Cannabis Liberalization In The US: The Policy Landscape (Health Affairs); Cannabis Legalization In The US: Population Health Impacts (Health Affairs)
Brookings followed up on their November report on alternatives to police as first responders for mental health crises, as in the last six months, there have been several steps taken. Congress passed legislation providing grants to jurisdictions to boost their capacity to handle the 988 system, a hotline that will connect callers with suicide prevention and mental health crisis counselors. Several states have already introduced bills to implement this system. In addition, many cities and counties are adopting crisis intervention team models and revising police training. The American Rescue Plan Act included grants and enhanced Medicaid federal matching rate for mobile crisis interventions, inspired by the CAHOOTS program, and increased federal funding for home- and community-based services for the Community Mental Health Services Block Grant and for school programs to address mental health and academic needs. Other state and local programs include the Street Crisis Response Team in San Francisco, Health One in Seattle, the STAR Program in Denver, Portland Street Response in Portland, Oregon, the Familiar Faces Program in Olympia and the Rapid Integrated Group Healthcare Team (RIGHT Care) in Dallas.
Source: How the American Rescue Plan Act will help cities replace police with trained crisis teams for mental health emergencies (Brookings)