FDA – OA REMS Announcement Concerning requirements to Manufacturers of Opioids
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New FDA – OA REMS Announcement

| by: Deneen Fumich, RPh | Article Posted: May 2, 2023 |

April 21, 2022, FDA published in the Federal Register open comments under the Support Act which authorized FDA to require through a Risk Evaluation and Mitigation Strategy (REMS) that a safe disposal packaging or safe disposal system for the purposes of rendering the drug non-retrievable be dispensed to certain patients with opioids or other drugs that pose a severe risk of abuse or overdose if, among other things, FDA determines that such safe disposal packaging or system may mitigate such risks and is sufficiently available (21 U.S.C. 355– 1(e)(4)).

The FDA issued notice on April 3, 2023, to all manufacturers of opioid analgesics used in outpatient settings that they must submit the proposed modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) within 180 days of the date of the notification letter. FDA anticipates approval of the modified REMS in 2024.

Implementation will require 2 activities of the manufacturers:

    • Have prepaid mail-back envelopes available for outpatient pharmacies to order directly from the manufacturer.
    • Develop educational materials for patients on safe disposal of opioid analgesics which outpatient pharmacies and other dispensers may also provide to patients.

However, is the FDA done in considering additional ways to increase the safe disposal of unused opioid analgesics? NO

On April 4, 2023, FDA published in the Federal Register announcing the establishment of a docket to obtain information and comments that will assist the Agency in assessing whether in-home disposal products can be expected to meet the public health goal of mitigating the risk of nonmedical use or overdose if the Agency were to require drug manufacturers to make in-home disposal products available to patients under a risk evaluation and mitigation strategy (REMS). Comments must be submitted by August 28, 2023.

The publication also announced a public workshop convened by the National Academies of Sciences, Engineering and Medicine’s (NASEM’s) Forum on Drug Discovery, Development, and Translation entitled “Defining and Evaluating In-Home Disposal Systems for Opioid Analgesics” on June 26 and 27, 2023.

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