FDA Remains Focused on Opioid Crisis, New Guidance Developing

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Recently, the United States Food & Drug Administration (FDA) Commissioner Scott Gottlieb released a statement highlighting the administration’s ongoing efforts to address the opioid crisis. The statement is somewhat of a progress report on the plan released by the Department of Health and Human Services (HHS) last year, and discusses three key areas where advancement has been made: (1) addressing opioid prescribing, (2) the marketing of illicit opioids, and (3) supporting novel product innovation. The statement also highlights more than a dozen steps the agency has taken in these areas, including developing new guidance, collaborating with other agencies, expanding oversight, and more.

In the statement, Commissioner Gottlieb indicated that FDA plans to withdraw their existing 2014 analgesic guidance document on developing new pain drugs due to issues in implementation. Gottlieb further clarified that the call for a large number of studies to develop a general chronic pain indication may have been too broad for its own good, and the health agency has instead determined a more focused approach would streamline drug development in specific areas.

According to the press release, at least four new guidance documents will be published to replace the retracted 2014 analgesic guidance, which will be released in a series over the next six to twelve months, to create a more efficient path for new product innovation.

    The first guidance is expected to be released soon will address drugs that can be used in place of opioids in the treatment of acute pain and establish the FDA’s current thinking on reducing the use of opioids for acute pain in a clinical meaningful way.

    The second guidance will outline the information that the FDA will ask drug makers to provide in order to assess the benefits and risks when new opioid pain drugs are put into development. This will include an updated framework for evaluating the risks associated with intentional or illicit misuse or abuse of drugs.

    Another guidance will outline a path for developing extended-release local anesthetics as an alternative to the systematic use of oral opioid drugs, in addition to addressing the clinical pharmacology, the proper evaluation of safety and efficacy, and the types of studies that may support approval of these products.

    The final document to be released from the FDA will look to assist sponsors with development of new non-opioid medication for chronic pain that can provide therapeutic alternatives to the use of opioids.

Gottlieb believes that a broader approach is needed as the opioid crisis continues to evolve, as the “epidemic is turning from one that was largely dominated by addiction formed in the medical setting, involving prescription drugs, to one that increasingly implicates the use of illicit drugs, including highly potent fentanyls. These drugs are obtained illegally, often through purchases made on-line, and in many cases shipped through the international mail.”

Commissioner Gottlieb also indicated that the agency is exploring the use of blister packs for opioid drugs as a method of better controlling prescription dispensing and reduce exposure. The FDA is actively considering other policy options, according to the Commissioner, including novel steps to better manage the use of high-dose opioid formulations.

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