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Biden should ease access to key opioid treatment

By: Kaitlin Edwards / 02.18.2021

From May 2019 to May 2020 the CDC reported over 81,000 overdose deaths from opioids in the United States, the biggest annual death toll to date. In a belated effort to mitigate the crisis, the Trump administration changed regulations to make it easier to access the opioid treatment drug buprenorphine in the waning days of his presidency. But the new Biden administration has reversed those changes because of legal concerns over the way the Trump administration implemented the policy.

The Trump changes were released amidst the chaos of the Capitol insurrection. When Elinore McCance-Katz, the health and Human Services (HHS) assistant secretary for mental health and substance use, resigned in the aftermath of the riots, the White House quickly appointed a replacement who greenlighted new “clinical guidelines” that made it easier for physicians to prescribe buprenorphine. McCance-Katz had refused to push these changes forward during her tenure. McCance-Katz had favored more safeguards to prevent buprenorphine from being overprescribed in fear of the drug starting a new epidemic of its own. 

Buprenorphine is one of three pharmacological treatments for opioid use disorders and is considered the easiest tolerated of the options. It has been shown to reduce overdose mortality by 50% and comes in a variety of forms, dissolvable films, and tablets being the most common. But stringent regulations make the drug difficult to get for people seeking opioid treatment. Under current law, doctors are required to complete special training and obtain an “X-waiver” license in order to prescribe buprenorphine. Only 5% of doctors in the country have the necessary waiver to prescribe it, and in rural areas, it’s even less.

The new guidelines allowed any physician with a Drug Enforcement Administration (DEA) prescriber license to prescribe buprenorphine. The drug is a narcotic that diminishes the symptoms of opioid withdrawal and is also safer, less addictive, and less likely to be misused. Despite its safety and efficacy, The federal government crafted these rules over two decades ago before the drug was approved by the Food and Drug Administration (FDA) to treat opioid use disorder in 2002. Ironically, opioids require no special training to be prescribed, unlike buprenorphine.

Many addiction researchers, physicians, and policy experts applauded the change in regulation. In the hasty process, however, the Trump administration did not obtain the necessary approval to change the regulations from the White House Office of Management and Budget (OMB).

Though the Trump administration may not have followed proper procedures, Biden’s decision to reverse its action sparked backlash from many policymakers and physicians who believe quick and drastic measures must be taken to ease the toll of the pandemic for people with substance use disorders. 

Overdose deaths have been steadily rising in the past decades and the pandemic has significantly exacerbated the rate. Synthetic opioids are believed to be the main substance that accelerated the overdose death rate during the pandemic. The CDC reported that two-thirds of opioid overdose deaths involve synthetic opioids. Experts estimate that the total economic burden of the crisis is over $78 million per year.

In addition to limited providers, people with substance use disorders often face other barriers to receiving treatment, especially in disadvantaged communities. These include lack of stable housing, health insurance, and stigma. COVID-19 intensified these problems by limiting in-person support groups, public transportation, and job security while increasing social isolation and stress.

Since buprenorphine is an opioid it does have the potential to be addictive. It is, however, safer and less addictive than the opioids that it is used to treat because of its pharmacological properties. It is also unlikely that the deregulation of this drug will lead to more opioid use disorders since it is only prescribed to treat opioid use disorders– unlike other opioids that are prescribed to alleviate pain. Ultimately the life-saving benefits that buprenorphine offers far outweigh the potential risks. 

Although the legal concerns over the way the Trump Administration removed these regulations are legitimate, the longer it takes the Biden administration to ease the restrictions on buprenorphine – or find an equivalent treatment – the direr the situation will become.

As a part of launching his multifaceted Opioid Crisis plan, President Biden should take executive action to remove X-Waivers in a legally surefire and quick manner. While removing the waivers will not solve the crisis overnight, it is a step in the right direction to treat people with opioid use disorders and prevent the overdose death rate from rising further.

This piece was also published in Medium.