'Bad actors' abuse rules to block generics, US Congress hears

A US Congress Subcommittee has heard that pharmaceutical companies can delay competition in the generics space by abusing Food and Drug Administration rules designed to enhance safety.

The subcommittee received testimony from the generics industry, academics and others on how certain “bad actors” have used the US FDA’s risk evaluation and mitigation strategies (REMS) guidance to refuse to sell their products to competitors.

This has enabled manufacturers of branded medicines to block competitors from accessing the reference drugs required for bioequivalence testing, a key step in getting generics approved by regulators.