Most of the new Genetic Metabolic Diseases Advisory Committee members have little FDA or advisory committee experience, except the new industry representative, with six more voting slots still to fill before its first meeting.

The US FDA’s new draft guidance notes its own efforts to combat misinformation and offers some creative examples to illustrate its advice, but avoids any potentially “controversial” contemporary situations.

A US House of Representatives bill to provide obesity drug coverage to a very select group of Medicare beneficiaries, passed only after Democrats debated whether the proposal is a “first step” towards broader coverage or a misstep counter to Medicare’s goals.

A Trump-aligned think tank doesn’t have too much to say about the US FDA – which is probably a good thing for the agency. But it does reinforce the reality that abortion politics will continue to impact the agency – and that ties to industry may be a bipartisan area of concern.

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.

US federal agencies are entering a new era of uncertainty and increased litigation over their regulatory interpretations, but the FDA may benefit from the unique circumstances that have evolved through user fee legislation.