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Yesterday, as part of its ongoing efforts to combat the current opioid crisis, FDA published a draft guidance, “Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework,” outlining the benefit-risk framework the Agency intends to use in assessing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The draft guidance explains how FDA intends to apply its existing benefit-risk assessment framework to evaluate the benefits of a candidate opioid analgesic drug as well as any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: