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Opioid-Reversal Drug Access to Ease Under Relaxed FDA Rules (1)

Sept. 22, 2022, 4:02 PMUpdated: Sept. 23, 2022, 3:53 PM

Harm reduction programs distributing the opioid-reversal drug naloxone are exempt from certain federal product tracing requirements in an effort to better expand supply, the FDA said Thursday.

The Food and Drug Administration said in guidance that it won’t enforce certain Drug Supply Chain Security Act requirements on programs distributing FDA-approved naloxone to underserved communities while an opioid public health emergency declaration is in place.

The document outlines the FDA’s approach to regulating the drug as the Biden administration prioritizes addiction treatments and harm reduction strategies in its fight against the opioid crisis.

“Combating the opioid overdose epidemic is an urgent public health priority for FDA,” the agency wrote in the guidance. The FDA “is committed to advancing solutions to reduce opioid overdose deaths in the United States, including by supporting efforts to increase public availability of and access to naloxone.”

Harm reduction programs have had difficulties acquiring naloxone in part because all three approved versions require a prescription, and because typically trading partners of a prescription drug manufacturer, wholesale distributor, repackager, or a dispenser must be authorized. The guidance clarifies two DSCSA exemptions triggered by the opioid public health emergency that was first declared in 2017.

The product tracing and verification requirements normally applied to trading partners of FDA-approved drugs “do not apply to the distribution of FDA-approved naloxone products to harm reduction programs or harm reduction suppliers during the opioid public health emergency,” the FDA said Thursday. Wholesale distributor licensing requirements also won’t apply to harm-reduction suppliers distributing naloxone.

The FDA said it doesn’t plan to take enforcement action against trading partners during the opioid public health emergency “that would otherwise meet the definition of wholesale distributor under the DSCSA” but “are currently engaged in distributing FDA-approved naloxone products for emergency medical reasons.” It also won’t take take action against donations of naloxone to harm reduction programs, according to Thursday’s guidance.

The guidance follows the Biden administration’s April release of its 2022 drug control plan, which included expanding naloxone access among its priorities. President Joe Biden has called on federal agencies to prioritize addiction treatment, crack down on international and domestic drug trafficking, and boost efforts to stop children and young adults from using addictive opioid products.

The FDA in August released a framework for overdose prevention to encourage harm reduction, as well as eliminate unnecessary initial prescription drug exposure and inappropriate prescribing of opioids.

The FDA has also launched an external review into the agency’s past opioid decisions.

The number of reported drug overdose deaths has risen to historic highs over the Covid-19 pandemic. The Centers for Disease Control and Prevention recorded more than 103,000 fatalities in the 12-month period ending April 2022.

Nearly 92,000 drug overdose deaths occurred in the US in 2020, 30% higher than the previous year, according to a July report from the CDC.

Black people saw the highest increase in overdose fatalities, going up 44% between 2019 and 2020, with overdoses deaths among American Indians and Alaska Natives increasing 39% in the same time period. These both outpaced the 24% increase in fatalities among White people.

(Updates Sept. 22 story with new CDC data on overdose deaths.)

To contact the reporter on this story: Celine Castronuovo at ccastronuovo@bloombergindustry.com

To contact the editor responsible for this story: Alexis Kramer at akramer@bloomberglaw.com