Beyond Individual Patients: FDA Emphasizes Public Health Role In Certain Benefit-Risk Decisions
US FDA’s new draft guidance on benefit-risk assessments for new drugs highlights cases where it can take into account broader public health implications than just the pros and cons calculus for the patients described in a drug's label. While not a new policy perse, it is one the agency seems to have only grudgingly employed in the past.
You may also be interested in...
Draft guidance explains how agency intends to consider therapeutic context in benefit-risk framework to, in rare cases, set aside CMC issues for later resolution under "quality postmarketing agreements."
Commissioner Califf testifies at budget appropriations hearing that the agency may ask Congress to give it authority to require a new opioid drug application to show superiority to opioids on the market.
Public Citizen’s request to place gabapentin on DEA’s controlled substances list may be a test case for how much weight FDA plans to give to broader public health impacts of drug approvals as opposed to the risk-benefit calculus for individual patients for whom a drug is labeled.