One speaker at the US FDA’s day-long “listening session” on advisory committee reform captured an important truth: the problem is not necessarily how committees are run, it is that there are no alternatives for public input into agency decisions.

In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.

The US Medicare agency is not moving forward with a proposal to cut payments for drugs with accelerated approval status pending further discussions with the FDA about whether new regulatory authorities have addressed concerns about timely completion of confirmatory trials.

Agency should be more proactive in issuing communications after advisory committee meetings, stakeholders advised; public interest group and industry representatives said the voting process is important for transparency and accountability.

The FDA does not appear likely to provide a calculation for sponsors to show clinical trial diversity, but agency officials seem split on how tough to enforce the new regulations intended to ensure all groups are adequately represented.