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# Opioid Benefit/Risk Framework Guidance
- URL: https://www.fdaweb.com/opioid-benefit-risk-framework-guidance/
- Published: 2019-06-20T12:00:00.000Z
- Updated: 2026-09-15T01:33:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144385

FDA has issued a draft guidance, *Opioid Analgesic Drugs: Considerations for Benefit/Risk Assessment Framework*, describing the benefit/risk framework the agency uses in evaluating whether applications for opioid analgesic drugs meet the standard for approval under Section 505 of the Federal Food, Drug, and Cosmetic Act. The [document](https://www.fda.gov/media/128150/download?ref=fdaweb.com) summarizes information that FDA says should be included in an NDA for an opioid analgesic drug to facilitate the agency’s benefit/risk assessment.

In an agency [statement](https://www.fda.gov/news-events/press-announcements/statement-fdas-benefit-risk-framework-evaluating-opioid-analgesics?ref=fdaweb.com) on the guidance, acting commissioner **Ned Sharpless** and CDER deputy director for regulatory programs **Douglas Throckmorton** say the agency will consider the benefits and risks of proposed new opioid analgesics relative to other already approved opioid and non-opioid analgesics.

“In terms of patient safety,” they say, “the agency recommends that companies consider providing information on whether their drug has any characteristics that would mitigate the risks of overdose, abuse, or the development of addiction. Companies should also indicate whether their drugs have novel or greater risks compared to other opioids on the market and also note the public health implications of their products in terms of risks to non-patients, including members of the patient’s household, visiting relatives, friends, and others.”

FDA also says it will hold a 9/17 [public meeting](https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-13219.pdf?ref=fdaweb.com) “to further discuss the agency’s benefit/risk assessment of opioid analgesics, including the manner in which risks of misuse and abuse of these products factor into the benefit/risk assessment. This meeting will include a discussion of whether an applicant for a new opioid analgesic should be required to demonstrate that its product has an advantage over existing drugs in order to be approved and, if so, what new authorities FDA would need to impose such a requirement. In addition, the agency will discuss whether new preapproval incentives (in addition to existing incentives, such as breakthrough designation) are needed to better support and encourage development of all therapeutics — opioid or non-opioid drugs, biological products, or devices — intended to treat pain or addiction.”

FDA says additional guidance to come will outline appropriate clinical endpoints and clinical trial approaches for development of non-opioid drugs for use in treating acute and chronic pain.