The Biden administration is ending its term with a flurry of actions meant to expand access to addiction treatment — and preserve its legacy of historic support for new ways to reduce drug-related harms.
In the last month, regulators have moved to ensure or expand access to evidence-based interventions for substance use disorders. While none of the new policies, individually, represents a paradigm shift in addiction medicine, the three actions collectively underscore the administration’s emphasis on treatment.
The Biden administration, more than any previous ones, has expressed support for harm reduction: the philosophy of taking steps to reduce injury and disease associated with drug consumption without demanding instant abstinence from substance users. In the last four years, the federal government has backed syringe exchange, the use of fentanyl test strips, and other harm-reduction techniques. It has also expanded access to medications like methadone and buprenorphine, as well as to the overdose-reversal medication naloxone, which the Food and Drug Administration approved for over-the-counter use in 2023.
In recent weeks, three separate federal agencies have moved to cement that legacy. In particular, experts say that one little-noticed and highly technical announcement on Dec. 26 could prove impactful: the FDA’s formal recognition that many patients require larger doses of buprenorphine, a common medication used to treat opioid addiction, than the guidelines listed on the medication’s label.
Buprenorphine and methadone, another medication, are key weapons in the fight against opioid overdose. But in the fentanyl era, many doctors and patients have reported that beginning treatment with buprenorphine, especially, has become more difficult.
Many doctors have compensated by simply providing larger doses, which a growing body of research suggests is both safe and effective. Last month, however, the FDA conceded that the labeling included with most oral buprenorphine is often seen as creating a de facto dosage cap.
Many insurers, both public and private, in turn used such dosage guidelines as justification for imposing requirements that forced providers to ask permission before prescribing large doses, risking a potentially deadly delay in patient access. Some authorities only recently lifted those restrictions — perhaps most notably, the District of Columbia’s Medicaid agency lifted prior authorization requirements for any dose below 32 milligrams in April.
“Current [buprenorphine] labeling has been misinterpreted by some as suggesting a maximum dosage of 16 or 24 milligrams daily although the labeling does not explicitly provide a maximum dosage,” said Marta Sokolowska, the deputy director for substance use and behavioral health at the FDA’s Center for Drug Evaluation and Research. The agency’s guidance, she added, seeks to clarify “that daily doses higher than 24 mg per day may be appropriate for some patients.”
The FDA was not the only agency to bolster buprenorphine’s availability in the last month. Separately, the Drug Enforcement Administration this week announced a long-awaited regulation that will allow licensed prescribers to continue providing buprenorphine via telemedicine, a continuation of Covid-era policies that, to date, have yielded access improvements without causing any corresponding danger.
The policy allows patients to continue receiving buprenorphine for six months, at which point they’d likely need an in-person examination before continuing to use the medication.
“We understand the difficulties some patients have accessing medical providers in-person, and we want to ease this burden while also providing safeguards to keep patients safe,” Anne Milgram, the DEA administrator, said in a statement.
A separate rule, also issued this week by the DEA, would create a special registration process for providers seeking to dispense other controlled substances via telemedicine, but the proposal was issued in draft form, meaning the Trump administration has no obligation to enact it.
Lastly, on Jan. 8, the Substance Abuse and Mental Health Services Administration announced a significant shift in how it regulates contingency management, a behavioral health intervention that provides financial rewards, like gift cards, to people who reduce their drug use.
SAMHSA had previously capped funding for contingency management services at $75 per year, a level that experts said was far too low to spark a genuine behavioral change. The new cap of $750 could lead to greater uptake of contingency management, which is seen as a particularly promising treatment to cocaine and methamphetamine addiction, especially since no medication is currently approved to treat addiction to either substance.
While drug deaths had increased sharply in the years prior to Biden’s inauguration and shot upward in 2020 amid the Covid-19 pandemic, rates still rose to record highs during his term. Only recently, after roughly a year of the overdose death rate hovering above 110,000 annually, did drug mortality begin to fall.
Though some advocates criticized the Biden administration for failing to treat the drug crisis with appropriate urgency, the past four years marked a significant shift in U.S. drug policy.
Under Biden, the federal government moved to increase access to addiction medications like methadone and buprenorphine, most notably via the first overhaul of the regulations governing methadone clinics in over 20 years. It also codified the repeal of the “X-waiver,” a special registration that doctors needed to obtain before they could prescribe buprenorphine.
Federal policy also shifted away from abstinence-only strategies and toward harm reduction — in short, a recognition that while eliminating substance use may be best, simply reducing it can still yield meaningful improvements in health. And while the administration has never formally endorsed the practice of supervised consumption, it has looked the other way while two sites opened in New York City and a third began operating in Rhode Island.
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