Opioids top FDA’s 2022 drug safety priorities report

Regulatory NewsRegulatory News | 02 March 2023 |  By 

The head of the US Food and Drug Administration’s (FDA) drug center said the agency has prioritized addressing the ongoing opioid pandemic over the past year to ensure drugs are used safely. In particular, the agency pointed to several initiatives such as going after online retailers selling illegal opioids and taking steps toward getting over-the-counter (OTC) naloxone to market.
On 2 March, FDA’s Center for Drug Evaluation and Research (CDER) published its annual drug safety priorities report for 2022. The report lists the agency’s ongoing work to address fraudulent COVID-19 drugs, shortage of critical drugs, and improving the quality of compounded drugs, a key focus of the report was on its work to tackle the opioid crisis.
“We continued to prioritize activities addressing the public health crisis arising from the recreational use of opioids and other controlled substances, which have taken a devastating toll on our country, with overdose deaths reaching more than 100,000 in the 12-month period ending in September 2022,” said CDER Director Patrizia Cavazzoni. “As part of this renewed commitment, this year we introduced FDA’s Overdose Prevention Framework a vision for our future approach for addressing this evolving crisis that focuses on four priority areas: primary prevention; harm reduction; evidence-based treatment for substance use disorders; and protecting the public from unapproved, diverted, or counterfeit medications presenting overdose risks.”
FDA’s Overdose Prevention Framework was launched in August 2022 to give the agency more focus and resources to fight the opioid crisis. The agency noted that the problem has evolved from just the illegal use of opioids to other drugs including benzodiazepines and stimulants such as methamphetamine that are used in combination with opioids.
Regulators said they have emphasized the prevention of opioid abuse by eliminating unnecessary initial prescriptions of opioids and when that’s not feasible, by preventing inappropriately long prescriptions for the drugs. They have also been encouraging harm reduction methods, advancing the development of evidence-based treatments for substance use disorders, and fighting counterfeit and unapproved opioids. (RELATED: FDA targets illegal online opioid retailers in new overdose prevention framework, Regulatory Focus 30 August 2022)
FDA is looking into allowing OTC naloxone products without a prescription on the market to prevent opioid overdose deaths. Last year, the agency published a notice where regulators said certain naloxone products, including nasal sprays that deliver up to 4mg of the drug and intramuscular or subcutaneous autoinjectors that deliver up to 2mg of the drug, may be safe and effective enough to be marketed without the need for a prescription. In February, FDA’s Nonprescription Drug Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee Meeting voted unanimously in support of Emergent Biosolutions’ application for an OTC version of its naloxone spray. (RELATED: FDA takes first step to allow low-dose OTC naloxone on market, Regulatory Focus 15 November 2022)
In the report, FDA also lists other actions it has taken over the past year including publishing guidances to help develop non-opioid pain medication and allow naloxone products on the market, holding a public meeting to address the problem with input from a wide range of expert stakeholders, and approving a second generic naloxone intranasal spray.


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