Gabapentin Petition Could Give FDA Opportunity to Revisit Tradeoffs In Opioid Oversight Debate
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.
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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US FDA’s new draft guidance on benefit-risk assessments for new drugs highlights cases where it can take into account broader public health implications than just the pros and cons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.
US FDA Learns 'Lessons Of History,' Takes Opioid Fight To Gabapentinoids
Agency investigating potential misuse and abuse of gabapentinoids, which CDC had recommended as alternative to opioids, in latest twist to epidemic.
Value-Based Pricing Bill with New Protections for Medicare and Medicaid Clears House Panel
Energy and Commerce Committee made some changes to a Trump-era regulation designed to make it easier for manufacturers to enter into value-based drug pricing contracts with commercial payers to limit unintended consequences for Medicaid and Medicare, but most Democrats say the tweaks don’t outweigh the harms of codifying the regulation.