Woodcock: High Prices Create Problems For Entire Accelerated Approval Program
Executive Summary
Acting FDA commissioner suggests a primary reason for outrage over accelerated approvals is the high costs of certain medications despite their unproven clinical benefits, an issue that is outside of the agency’s purview. Health policy experts says FDA shouldn’t be left off the hook that easily.
You may also be interested in...
Accelerated Approval Price Caps: Policy Has High Profile Support – But Can It Be Done?
US Medicare Payment Advisory Commission likely to recommend that drugs granted Accelerated Approval be subject to some form of price cap when confirmatory clinical data is lacking. The idea has a lot of supporters, but even they seem a bit unclear about how it could actually work.
Sen. Wyden Using Califf Nomination To Extract Accelerated Approval Reforms
The unexpectedly tight fight to get Robert Califf confirmed as FDA commissioner is giving lawmakers additional leverage to extract commitments. However, the Senate Finance Chair may be overestimating FDA’s ability to swiftly pull accelerated approvals without new legislation.
Aduhelm & Medicare: HHS Reconsideration Of Premium Hike May Ease Blowback On Coverage
Biogen’s Alzheimer’s drug may not cause as much of a financial headache to American seniors as expected, which could dampen criticism of Medicare’s upcoming coverage determination. But questions remain about what exactly HHS will be able to do about Part B premiums.