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FDA Recaps 2018 Efforts, Lays out 2019 Policy on Opioids

March 4, 2019
The agency released its regulatory agenda for continuing to address opioid abuse

A PPM Brief

Scott Gottlieb, MD (who, on March 5th, 2019, resigned as FDA commissioner), released a statement1 reviewing FDA's 2018 accomplishments on the national crisis of opioid abuse, while also outlining goals for the remainder of this year.

Key FDA Actions in 2018

  • Expanded REMS for extended-release and long-acting (ER/LA) opioid analgesics to include immediate-release (IR) products intended for use in an outpatient setting; updated boxed warnings for these products to include information about the REMS.
  • Worked with Congress to secure explicit authority to take action, as needed, on the basis of opioid risks; authority included in the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act.
  • Worked with NAM to create scientific frameworks for developing evidence-based prescribing guidelines that provide specific recommendations on the proper dosing and dispensing of opioids based on specific clinical indications.
  • Since 2017, warned a total of 23 networks operating more than 450 websites for illegally marketing potentially dangerous, unapproved, and misbranded versions of opioid medications, including tramadol and oxycodone.
  • Increased interdiction work in the International Mail Facilities (IMFs), expanding enforcement efforts aimed at stopping the illegal flow of counterfeit and unapproved prescription opioids.
  • Restricted entrance of illicit articles containing active pharmaceutical ingredients (APIs), treating illegally imported articles as drugs when they meet certain requirements (even in the absence of evidence of intended use), while working on new tools to identify analogues of APIs.
  • Increased accessibility of medication-assisted treatment (MAT) and reducing the stigma associated with it.

(Source: 123RF)

FDA Planned Actions for 2019

New opioid reviews & risk mitigation: The agency, according to Commissioner Gottlieb, will be taking new steps to reduce exposure to opioid analgesics in 2019 by ensuring that appropriate prescription dose, quantity, and treatment durations match indications. With regard to potential new opioids, the agency wants to develop a framework for the formal evaluation of each candidate opioid in the context of how a novel opioid might fit into the overall therapeutic armamentarium for both practitioners and patients alike, “asking whether new opioid drugs should offer some comparative benefit over existing drugs.”

The agency will also pursue new efforts around evaluating the effectiveness of existing REMS programs for opioid products, including data collection and assessment tools.

MAT: FDA will prioritize MAT, including new industry guidance aimed at supporting novel medicines and medical devices,  as well as new policies to promote MAT adoption. The agency will also work with partner stakeholders to continue to reduce stigma around opioid addiction.

FDA will work to broaden the availability of naloxone through over-the-counter (OTC) sales, building upon last year’s Drug Facts Labels (DFL) model which provides easy instructions on how to use the emergency overdose drug. Earlier this year, the agency also announced that it was “seeking to work with industry partners who are interested in developing these OTC naloxone products.”

Abuse-Deterrence: The agency hopes to take new steps on promoting the development of non-addictive drugs for pain, with plans to issue an updated guidance outlining the appropriate clinical endpoints and trial approaches for the development of non-opioid drugs for use in the treatment of acute and chronic pain. The agency will be promoting the development of abuse-deterrent formulations by exploring new methods for analyzing and evaluating its features.

Lastly, Gottlieb noted that the agency will strengthen its enforcement on the unlawful marketing or distribution of illicit opioids and other unapproved drugs, including by increasing the number of investigators in the IMFs and expanding collaboration with internet stakeholders to curb illicit online drug sales. The agency received $20 million to create a data warehouse to improve analytic capabilities for evaluating social and clinical trends affecting the trajectory of the opioid crisis. The agency will also work to tighten security around legitimate supply chains by ensuring that manufacturers, repackagers, wholesale distributors, dispensers, and others are taking measurable steps to appropriately track, trace, and respond to incidents related to illegal opioids.

Last updated on: March 6, 2019
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FDA Approves Final Opioid Analgesic Risk Evaluation and Mitigation Strategy
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