Description:
H.R. 4976 would require the Food and Drug Administration (FDA) to seek recommendations from an expert advisory committee before approving any new drug that contains an opioid that does not have abuse-deterrent properties. The bill would also require that the Pediatric Advisory Committee recommend labeling information for opioid use by children. In addition, the bill would require FDA to develop recommendations for educating prescribers of opioids and to publish final guidance on evaluating efforts to deter abuse of generic opioid drugs.
CBO estimates that enacting H.R. 4976 would not have a significant budgetary effect because FDA is currently implementing similar requirements through their action plan on opioids. Enacting H.R. 4976 would not affect direct spending or revenues; therefore, pay-as-you-go procedures do not apply. CBO estimates that enacting H.R. 4976 would not increase net direct spending or on-budget deficits in any of the four consecutive 10-year periods beginning in 2027.
H.R. 4976 contains no intergovernmental or private-sector mandates as defined in the Unfunded Mandates Reform Act and would not affect the budgets of state, local, or tribal governments.
