Formal MACPAC proposal to US Congress to consider enhanced rebates for drugs approved via the Accelerated Approval pathway could have a long shelf life in the context of debates over drug pricing – and over FDA regulatory reforms.

A decision made more than 15 years ago by CMS to require drug insurance plans to cover all drugs for six specific diseases has proven impervious to change. But will the protected classes remain if Part D is reformed more broadly?

A Senate hearing on the US COVID-19 response recalled Kessler’s tenure as FDA commissioner a quarter century ago – and included some reminders that things have changed.

There won’t be a lot of legislative action in Congress in the weeks following passage of the $1.9tn American Rescue Plan. But the coming months are a critical time for the drug industry to try to set the terms for how it is treated in the next major bill later this year, and the stakes could not be higher.

Most US agencies can expect relatively friendly oversight from a Democratic Congress. The US FDA might be one exception, as a recent House hearing on foreign inspections shows.

Past support for so-called ‘march in’ rights is a red flag for biopharma innovators, but after two days of confirmation hearings, industry can be somewhat reassured.