Key result
The Anesthetic and Analgesic Drug Products Advisory Committee has reviewed numerous anesthetic and opioid-related applications since 2017 to balance benefit-risk relationships during the opioid crisis.
Why the study?
The report aimed to describe the activities of the Anesthetic and Analgesic Drug Product Advisory Committee as it balances individual benefit-risk relationships with public health implications of new opioids.
This report summarizes the FDA Anesthetic and Analgesic Drug Products Advisory Committee's decisions and activities since 2017, highlighting the balance between individual patient benefit and public health implications in the opioid-crisis era.
The United States Food and Drug Administration is tasked with ensuring the efficacy and safety of medications marketed in the United States. One of their primary responsibilities is to approve the entry of new drugs into the marketplace, based on the drug's perceived benefit-risk relationship. The Anesthetic and Analgesic Drug Product Advisory Committee is composed of experts in anesthesiology, pain management, and biostatistics, as well as consumer and industry representatives, who meet several times annually to review new anesthetic-related drugs, those seeking new indications, and nearly every opioid-related application for approval. The following report describes noteworthy activities of this committee since 2017, as it has grappled, along with the Food and Drug Administration, to balance the benefit-risk relationships for individual patients along with the overarching public health implications of bringing additional opioids to market. All anesthesia advisory committee meetings since 2017 will be described, and six will be highlighted, each with representative considerations for potential new opioid formulations or local anesthetics.
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Ronald S. Litman (2020) conducted a review in Opioid and anesthetic drug approvals. Anesthetic and Analgesic Drug Products Advisory Committee review was evaluated. The Anesthetic and Analgesic Drug Products Advisory Committee has reviewed numerous anesthetic and opioid-related applications since 2017 to balance benefit-risk relationships during the opioid crisis.
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