Beyond Individual Patients: FDA Emphasizes Public Health Role In Certain Benefit-Risk Decisions

The US Food and Drug Administration highlighted its ability to incorporate broader public health considerations into its risk-benefit assessments in a new draft guidance on how considerations of a drug’s benefits and risks factor into FDA’s approval decisions and post-market regulation of drugs and biologics.

“In certain circumstances, such as in the review of drugs to diagnose and treat communicable diseases or drugs identified as controlled substances, FDA’s benefit-risk assessment incorporates broader public health considerations...