The Food and Drug Administration (FDA) authorized R.J. Reynolds to sell three of its Vuse vape products, the first premarket tobacco product application approval. The FDA also denied the company permission to sell 10 flavored products. The authorized products are all tobacco flavored and were determined to be less likely to appeal to youth and more likely to be used by people who smoke cigarettes to reduce their risk of harm. Advocates supported the denial of the flavored products but were wary about the authorization because the products contain high amounts of nicotine (three times the concentration legally permitted in Canada, the United Kingdom and Europe) and are a popular brand among youth. The authorization includes restrictions on digital, radio and television advertising for the products and requires regular reporting to the FDA.
Source: US FDA OKs Vuse e-cigarettes, its first vape authorization (CNN)
So far, 18 states have commercial marijuana legalization, under which for-profit companies grow, cultivate and sell marijuana, regulating marijuana like alcohol. There are concerns that the current model will lead to “Big Marijuana,” a large industry that, like the tobacco, alcohol and opioid industries, has a powerful financial incentive to market and sell its products to as many people as possible, no matter the consequences. As other states move to legalize cannabis, it is possible to follow an alternative model. The standard commercial model doesn’t work well for alcohol. Studies have shown that states with a government-operated monopoly for alcohol kept prices higher, reduced access to youth and cut overall levels of use. Other models of legalization for marijuana could include communal own-grow and distribution, government operation of the supply chain and nonprofit organizations. These models could all help reduce the profit incentives and growth of big industry.
Source: A better way to legalize marijuana (Vox)
A coalition of trade associations tied to major cigarette manufacturers, including the National Association of Convenience Stores, is warning that if lawmakers tax tobacco to help pay for the Build Back Better bill, suppliers will market tobacco to children. Though the tobacco companies are not named directly on the letter, Altria, Reynolds and Juul are all members of the convenience store association. The groups argue that if the price of tobacco products spikes, buyers would move to the black market, where sellers do not abide by regulations and often prey on youth. By hiding behind the convenience store groups, Big Tobacco can argue their case without putting their names directly on it and making lawmakers skeptical. Advocates maintain that raising taxes is effective at reducing use of the products, especially among kids. The manufacturers are also trying to argue that the proposal would contradict President Biden’s promise not to raise taxes on individuals making less than $400,000 a year.
Source: Big Tobacco comes out swinging against Biden’s Build Back Better bill (Politico)
Lobbyists are trying to block a bid by Senator Joe Manchin to add a tax on prescription opioids to the reconciliation package as one of his requirements for supporting the legislation. The proposal is drawing criticism from advocacy groups focused on chronic pain and drug supply chains. Democratic leaders have not yet said whether they will accept the proposal. Earlier this year, Manchin introduced a bill that would provide permanent funding for addiction treatment by placing a small fee on prescription opioids. Manufacturers, producers or importers would pay one cent on each milligram of active opioid ingredient per dose, with exclusions when prescribed to hospice and cancer patients and for medications to treat opioid use disorder. The fee would fund the Substance Abuse Prevention and Treatment Block Grant. Some states (e.g., Delaware, New York) have implemented similar taxes.
Source: Manchin’s opioids tax plan faces backlash from lobbying groups (Roll Call)
The Food and Drug Administration (FDA) issued its first warning letters to companies for continuing to unlawfully market e-cigarette products that received Marketing Denial or Refuse to File orders or that did not submit premarket tobacco product applications. Collectively, the 28 companies have listed more than 600,000 products with the FDA. However, the FDA also rescinded the marketing denial orders it issued to Turning Point Brands, affecting several hundred vaping products. The FDA said it had found relevant information in the application that was not adequately assessed. This included data from randomized controlled trials comparing tobacco-flavored e-cigarettes to flavored e-cigarettes, as well as studies evaluating patterns of use, likelihood of use and perceptions among those who use and do not use tobacco or e-cigarettes. FDA will not attempt to stop Turning Point Brands from selling the e-cigarette products now back under review.
Source: FDA In Brief: FDA Warns Firms for Continuing to Market E-cigarette Products After Agency Denied Authorizations (Food and Drug Administration); FDA Rescinds Previously Disclosed Marketing Denial Order for Turning Point Brands’ Vapor Products (Turning Point Brands)
New York Governor Kathy Hochul signed five bills aimed at reducing overdose deaths and encouraging those with addiction to seek help. S.911/A.235 decriminalizes the possession of opioid antagonists. S.1795/A.868 establishes a program for the use of medications for addiction treatment for incarcerated individuals in state and local correctional facilities. S.2523/A.868 decriminalizes the possession and sale of hypodermic needles and syringes. S.6044/A.128 establishes an online directory for distributors of opioid antagonists. S.7228/A.5511 expands the number of eligible crimes committed by individuals with addiction that may be considered for diversion to an addiction treatment program and updates the term “substance abuse” to “substance use.” Hochul shared the story of her nephew, who died of an overdose six years ago. He was prescribed opioids after receiving a cut at the deli where he worked, was denied addiction treatment after a mix-up with Medicaid papers and died after receiving a product laced with fentanyl.
Source: Governor Hochul Signs Legislation Package to Combat Opioid Crisis (Governor Kathy Hochul)
The Centers for Medicare and Medicaid Services approved a new Essential Health Benefits benchmark plan in Colorado, which will take effect in 2023. The new plan will address substance use disorder by expanding the number of drugs that insurance companies are required to cover in their prescription drug formularies as alternatives to opioids, as well as requiring coverage for up to six acupuncture visits per year. The plan also includes an annual mental health wellness exam — one 45-60-minute visit with a qualified mental health care provider per plan year. This visit can include services such as behavioral health screening, education and consultation about healthy lifestyle changes, referrals to ongoing mental health treatment and discussion of potential medication options.
Source: Biden Administration Announces Approval of Colorado’s Inclusive Health Care Plan to Set Colorado’s Essential Health Benefits (Colorado Division of Insurance)
Louisiana’s attorney general reached an agreement in principle with organizations representing the state’s sheriffs, police juries and municipalities on how to divvy up the $325 million the state expects to receive from the national settlement with opioid distributors. Sheriffs will receive 20% of the money. Parishes, cities and towns will split the other 80%, divided based on a nationally devised formula that uses population and the number of opioid prescriptions and deaths. The state health department and other state agencies will not receive any of the money, except for administrative costs related to an opioids abatement council. The council will review the spending of the money by local agencies to ensure they are following the guidance that the funds go to addiction treatment.
Source: Louisiana opioid settlement money to go to local governments (Associated Press)
National Institute on Drug Abuse Director Nora Volkow discusses in a blog the HEALthy Brain and Child Development (HBCD) study, for which the first awards were just made. It will recruit a large cohort of pregnant women and follow them and their children from the prenatal period through early childhood. It will examine the long-term impact of environmental adversity during pregnancy, including prenatal substance exposure, neglect, trauma and social and economic challenges. Longitudinal studies such as the HBCD and the Adolescent Brain Cognitive Development (ABCD) studies are crucial amid the COVID-19 pandemic to determine the impact on children’s development and mental health. The ABCD study, currently in its fifth year, continues to collect data on topics including early adolescent substance use. Researchers are already publishing data on changes in adolescents’ alcohol and nicotine use since the start of the pandemic. The studies will help highlight risk and protective factors for youth.
Source: Longitudinal Studies of Children Will Provide Needed Insight about the Developmental Impact of the Pandemic (National Institute on Drug Abuse)
The National Quality Forum Committee issued recommendations on quality measures for individuals with co-occurring mental health and substance use disorders. While quality measures independently exist related to substance use and behavioral health, there is a dearth of measures related to the intersection between the two. Measurement-based care, in which clinical care is based on data collected through structured assessments of treatment responses, has been a challenge for this population. The Committee identified essential domains to advance care and measurement for the population that should be included in a quality measure framework. These include equitable access, evidence-based clinical interventions and integrated, comprehensive care for concurrent behavioral health conditions. Stakeholders can address payment, data continuity, parity in criminal justice settings, expansion of access in rural settings and advancement of evidence-based treatment, including harm reduction services, to support further advancement of the field.
Source: To Overcome America’s Opioid Crisis And Reduce Disparities, Coordinated Measurement Is Critical (Health Affairs)