FDA to tackle overdose crisis with Overdose Prevention Framework

In its efforts to fight the current opioid crisis, the Food and Drug Administration (FDA) published on Tuesday its Overdose Prevention Framework. The Framework reflects the agency’s “vision to undertake impactful, creative actions to prevent drug overdoses and reduce deaths.”

As their press release notes, the Overdose Prevention Framework aligns with the Department of Health and Human Services (HHS) 2021 Overdose Prevention Strategy and “supports the National Drug Control Strategy.”

The four overreaching priorities within the FDA Overdose Prevention Framework are:

  • Supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing.
  • Encouraging harm reduction through innovation and education.
  • Advancing development of evidence-based treatments for substance use disorders.
  • Protecting the public from unapproved, diverted, or counterfeit drugs presenting overdose risks

Since the agency considers the overdose crisis an evolving public health crisis, it “continues to evaluate our approach and make adjustments according to the latest available science and data.”

Targeting illegal online opioid retailers

As per Regulatory Focus, the FDA plans to fight the current opioid crisis “by going after online drug retailers and promoting the development of non-opioid alternatives.”

The agency “has been aggressively working to address controlled substances illegally sold online, including through high-impact partnerships,” the release said. FDA Commissioner Robert Califf said that “cracking down on such activities while securing the supply chain for approved opioids and other controlled substances is a top priority.”

He also noted that FDA needs new approaches to counter the rapid growth of illicit, chemically synthesized fentanyl, fentanyl analogs, and methamphetamines on the market.

“In April 2022, we also partnered with the Drug Enforcement Administration to issue first-of-their-kind joint warning letters to operators of two websites illegally selling Schedule II stimulants, including amphetamine drug products marketed as Adderall,” Dr. Califf added.

Overdose plague

As per FDA’s release, “in 2017 the opioid crisis was determined to be a public health emergency.” That is still the case today, though the crisis has been exacerbated by the COVID-19 pandemic.

According to data from the National Center for Health Statistics, a record number of Americans – more than 107,000 – died from a drug overdose in 2021.

The Substance Abuse and Mental Health Services Administration (SAMHSA) latest estimates say that “18.4 million people suffer from illicit drug use disorders.” While accelerating in all demographics, the increase in drug overdose deaths “is particularly growing among non-Hispanic Black and non-Hispanic American Indian or Alaska Native populations, and rural Americans.”

Back in May, Camelia Thompson, Senior Director of Science & Regulatory Affairs at the Biotechnology Innovation Organization (BIO), stressed that “unfortunately, after years of dragging their feet, the FDA’s guidelines feel like too little, too late.”

“We’re still in the middle of an opioid epidemic,” Thompson explained. “The FDA withdrew the first guidance on non-opioid analgesics in 2017 and it has been five years where there’s been no guidance to the industry on the development of these types of medicines.”



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