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Focus on Regulation

FDA issues benefit-risk framework for assessing opioid drug applications, announces public meeting

Agency seeks input on “comparative advantage” requirement for new opioids

Yesterday, as part of its ongoing efforts to combat the current opioid crisis, FDA published a draft guidance, “Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework,” outlining the benefit-risk framework the Agency intends to use in assessing whether a new opioid drug application meets the statutory standard for approval.  FDA also announced it will hold a public meeting on September 17 to discuss this benefit-risk assessment framework as well as potential new preapproval incentives to foster the development of new treatments for pain and opioid addiction.  This public meeting will fulfill the SUPPORT Act requirement that FDA hold at least one public meeting annually to “address the challenges and barriers of developing non-addictive medical products intended to treat acute or chronic pain or addiction.”

The draft guidance explains how FDA intends to apply its existing benefit-risk assessment framework to evaluate the benefits of a candidate opioid analgesic drug as well as any risks, including abuse, overdose, addiction, or opioid use disorder.  FDA also indicated it will consider the benefits and risks of the opioid analgesic at issue with those of other approved therapies, including opioid and non-opioid alternatives, in addition to the broader public health risks posed by the candidate drug to both patients and non-patients.

Importantly, while FDA will consider how the new opioid analgesic compares to existing therapies, a sponsor will not be required to show that its drug is superior to the other treatments for approval.  Nonetheless, at the public meeting in September, FDA seeks stakeholders’ input regarding the addition of a comparative advantage requirement for approval of potential opioid analgesic drugs as well as:

  • What new authorities FDA would need to impose such a requirement, and how comparative advantage could be defined
  • Whether a proposed product could meet this standard even if the product carried additional or novel risks compared to existing products
  • Whether there should be any exceptions to a proposed comparative advantage requirement, e.g., for medically necessary drugs in shortage
  • How this requirement would affect product development, patients, providers, and the public health generally

In addition to the benefit and risk factors provided by FDA in the draft guidance, FDA is seeking input on the following at the public meeting:

  • New authorities FDA might need to fully assess candidate opioid analgesics
  • Consideration of existing therapies when reviewing an application for a new opioid analgesic
  • Whether new preapproval incentives are needed to better encourage development of therapeutics (opioid or non-opioid drugs, biological products, or devices) intended to treat pain or addiction

In announcing the release of the draft guidance and the withdrawal of the 2014 draft guidance “Analgesic Indications: Developing Drug and Biological Products,” Acting FDA Commissioner Ned Sharpless, M.D., highlighted the “crisis of opioid addiction” in the U.S. and noted the  draft guidance relies upon the conclusions of a July 2017 National Academies of Science, Engineering, and Medicine (NASEM) report that identified additional actions FDA should consider to address opioid abuse disorder.  Sharpless added that FDA plans to issue separate guidance to outline appropriate clinical endpoints and clinical trial approaches for the development of non-opioid drugs to treat acute and chronic pain.

The public comment period on the draft guidance ends August 20.  If you have any questions relating to FDA’s opioid analgesic assessment framework, or wish to comment ahead of the September 17 hearing, feel free to contact any of the authors of this article or the Hogan Lovells lawyer with whom you regularly work.