Policy News Roundup: December 12, 2024

Supreme Court skeptical of vaping industry arguments

The Supreme Court heard arguments last week in a case in which e-cigarette companies challenged the Food and Drug Administration’s (FDA) rejection of their flavored products. The Court appeared unsympathetic to the companies’ argument.

The backstory:

• The FDA determined that the companies, Triton Distribution and Vapetasia, did not provide sufficient evidence to demonstrate that flavored products’ benefits for adult smokers would outweigh the risks to youth.
• The companies argued that the FDA changed its requirements unfairly by abruptly requiring long-term studies showing whether flavored vapes are more effective than tobacco-flavored ones in helping people stop smoking. The famously conservative Fifth Circuit Court of Appeals agreed with the companies and ordered the FDA to conduct another review.
• The FDA appealed the ruling to the Supreme Court, arguing it properly considered the applications and that the appeals court misinterpreted administrative law.

At the Supreme Court:

• The three liberal justices on the Supreme Court appeared skeptical of the vaping companies’ argument that the FDA unlawfully changed its standards and reiterated the FDA’s concerns about flavors’ appeal to youth.
• Some of the conservatives on the court were also skeptical that the FDA changed its standards and questioned whether there would be any point in asking the FDA to reconsider its decision, noting the companies already have the option to reapply for approval.
• Other conservative justices seemed more sympathetic to the companies, appearing to agree with their claims that the FDA was not consistent and didn’t provide sufficient notice of changes.

Why it’s important: Flavored vapes appeal to kids, and youth are particularly susceptible to the risk of addiction and other harms from the products.

• The hearing comes as president-elect Donald Trump has vowed to “save” the vaping industry. If the FDA is directed to reevaluate the companies’ applications, the Trump administration could reach a different conclusion on flavored vapes than the FDA under President Biden.
• If the Supreme Court upholds the lower court’s ruling and rolls back the FDA’s decisions on e-cigarettes, it may undermine the FDA’s congressionally mandated authority to regulate tobacco products. It could force the FDA to reconsider millions of applications to market e-cigarette products.

What’s coming: A decision is expected by the end of the Supreme Court term in June.

Source: Supreme Court poised to enter fray over regulation of flavored vapes (The Washington Post); The huge stakes in a Supreme Court case about vaping (Vox); Supreme Court appears skeptical of vaping firm’s challenge to FDA (Politico); Supreme Court tackles case involving FDA’s oversight of flavored vapes (STAT)

The main point: Two new studies demonstrate that U.S. life expectancy is, and will continue to be, lower than peer countries’, in part due to drug-related deaths.

A Bloomberg American Health Initiative report found that average life expectancy in the U.S. is 78.6 years, vs. 81.3 years in England and Wales. Preventable causes – heart disease, overdose, firearm violence and motor vehicle crashes – explain the gap.

• Overdose is the second leading contributor to the gap, with the U.S. overdose death rate more than three times greater than that in England and Wales. For people under 25, overdose rates are 4.5 times higher in the U.S.
• The death rate for firearm-related homicides and suicides is 133 times higher in the U.S. than in England and Wales. For people under 25, rates are 485.9 times higher in the U.S.
• The death rate from motor vehicle crashes in the U.S. is 6 times greater than the rate in England and Wales.
• Recommended health policies for the U.S. include expanding access to addiction treatment through community pharmacies and correctional facilities, building a national community mental health infrastructure and enforcing penalties for impaired driving.

A Lancet study found that life expectancy in the U.S. is projected to increase through 2050 but modestly compared with that in other countries around the world, resulting in the U.S. declining in global rank.

• Drug use disorders are projected to increase to be among the leading causes of premature death and loss of healthy years to disability in 2050.
• Mortality rates from drug use disorders are projected to increase, making the U.S. rate the highest in the world and more than twice as high as the runner-up, Canada.
• Improvements in drug use and smoking would lead to 0.4-0.6 additional years of life expectancy and healthy life expectancy in 2050 and 1.2 million and 2.1 million fewer deaths, respectively.

Source: New Report: Life Expectancy Years Shorter in the United States Compared to the United Kingdom (Bloomberg American Health Initiative); America’s health status decline (Axios)

The current administration and Congress are wrapping up their terms with some final actions in the substance use space.

Psychedelics: The Department of Veterans Affairs (VA) announced that it is funding a $1.5 million study into psychedelic therapy for veterans, the first time the VA has funded such research since the 1960s.

• Researchers will examine whether MDMA combined with therapy is safe and effective treatment for post-traumatic stress disorder (PTSD) and alcohol use disorder (AUD).
• Why it’s important: The study follows the FDA’s rejection of an MDMA treatment for PTSD earlier this year. The VA is the largest health system in the country and serves a population with disproportionately high rates of PTSD and AUD.

Office of National Drug Control Policy (ONDCP): The House voted last week 399-1 to reauthorize ONDCP until 2031.

• The reauthorization bill also renews ONDCP’s High-Intensity Drug Trafficking Area program, which aids local law enforcement, and Drug-Free Communities Program, which gives grants to community organizations to reduce substance use among young people.
• Why it’s important: ONDCP is a White House office central to the coordination of actions across the administration to address substance use. Its authorization expired on September 30, 2023.

SUPPORT Act: Lawmakers are weighing attaching a health care package to a stopgap end-of-year government funding bill to keep the government funded until late March.

• Why it’s important: The proposal includes a full reauthorization of the SUPPORT Act, the 2018 law addressing the opioid crisis that expired last year. The Democrats’ counterproposal also includes bipartisan provisions on mental health care and stopping ghost networks, as well as an extension of the enhanced premium subsidies for Affordable Care Act (ACA) plans through 2026.
• But: Republicans propose to pay for it by repealing a Biden-era rule to increase nursing home staffing, which could be a no-go for Democrats. It is not clear if Republicans would agree to the ACA subsidies extension. Negotiations remain ongoing.

Farm Bill: Democratic and Republican farm bill negotiators are trying to hammer out an agreement for a farm bill extension before a year-end funding cliff.

• Why it’s important: In 2018, the Farm Bill legalized hemp, which has resulted in the proliferation of businesses selling unregulated, intoxicating hemp-derived products (e.g., delta-8 THC), including to kids. There have been proposals to close this loophole in this year’s farm bill reauthorization, but it is not clear if it will make it into the final bill.

Telemedicine prescribing: Although the Drug Enforcement Administration recently extended rules allowing the prescribing of controlled substances without an in-person visit through the end of 2025, Biden officials could still release a longer-term proposal to shape future regulation.

• A proposal is undergoing White House review.
• Why it’s important: The rules, originally implemented in response to the COVID pandemic, have eased access to prescription medications including buprenorphine. Many addiction treatment providers are concerned that eliminating these flexibilities could cut people off from needed treatment.
• But: The incoming Congress and administration could overturn or discard new regulatory actions coming from the Biden administration.

Trump’s pick to lead the Drug Enforcement Administration, Chad Chronister, abruptly withdrew his name from consideration, just days after being chosen.

• He said he made the decision “as the gravity of this very important responsibility set in.” He did not cite a reason for this withdrawal other than concluding he wanted to continue in his current role as a sheriff, but he had been facing some opposition.

Source: Trump’s DEA nominee withdraws (Politico)