Michael McCaughan
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Latest From Michael McCaughan
US Medicare To Codify Inflation Rebates, Adds Reconciliation Process
The US Medicare agency is creating a formal reconciliation process for new inflation rebates in Part B and Part D of the program.
First Four Members Of US FDA’s Newest Advisory Committee Are Mostly Rookies
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.
US FDA Misinformation Guidance: Leading By Example
The US FDA’s new draft guidance notes its own efforts to combat misinformation and offers some creative examples to illustrate its advice, but avoids any potentially “controversial”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.
Slimmed-Down Obesity Drug Coverage In Medicare: First Step Or False Start?
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.
Project 2025 And The US FDA
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.
Closing Thoughts On US FDA Advisory Committee Reforms
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.