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Speaker cites rise in generic approvals and pushes OTC conversions, criticizes PBMs
Summary
The official said FDA generic approvals rose to about 91 last year (up ~20%), urged converting more drugs to over-the-counter status for price visibility, and criticized PBM practices like spread pricing and specialty classification.
The agency official said approvals of traditional generic drugs by FDA scientists are up about 20%, totaling roughly 91 approvals last year. The speaker linked more approvals to increased competition and price transparency in the market.
"Approvals are up about 20% to 91 generic drug approvals last year and that means more competition," the official said. The speaker also advocated increasing the number of drugs available over the counter, saying that visible shelf prices allow shoppers to compare costs in real time.
The official criticized pharmacy benefit managers for mechanisms that can inflate costs, citing "spread pricing" and the improper categorization of some drugs as specialty products that require specialty pharmacies and limit options for patients.
