Michael McCaughan
Latest From Michael McCaughan
US FDA Alzheimer Guidance Update Reflects Changes In Biomarkers – And Leadership
Latest update to draft guidance on early Alzheimer’s drug development is the third iteration of a document first published in 2013. The history of the guidance is a reflection of structural and leadership changes in the neurology review team at FDA.
Biden’s Co-Pay Cap Is Silver Lining For Pharma In Drug Pricing Campaign
President Biden’s call to expand the US Medicare price negotiation program is naturally making headlines from his campaign-year State of the Union Address. But his call for a national cap on co-pays could be an important opportunity for industry in the years to come.
US FDA Gene Therapy Staff-Up: Glass Three-Quarters Full?
Aggressive staffing goals for FDA’s gene and cell therapy review group might not be fully achieved – but the head of CBER believes the new organization is on track to deliver on his high expectations going forward.
The Real ‘Pill Penalty’: US Biosimilar Law, Not The IRA
Biopharma industry is making some modest headway in quest to change the new US Medicare drug price process to treat drugs and biologics on equal footing. But eliminating the so-called ‘pill penalty’ would not on its own equalize the incentives for small molecule and large molecule R&D.
Medicare Price Negotiation Poses Challenges For Safety Net Providers
New drug pricing program under the Inflation Reduction Act could reduce the value of the 340B drug discount for safety net providers by as much as $1 billion in the first year, an analysis by the 340B Health association suggests.
340B Program At ‘Critical Inflection Point,’ Oversight Agency Head Tells Providers
The head of the federal agency overseeing the 340B drug discount program offers unusually direct calls for legislative action during the safety net provider association winter conference. But is action likely in Congress any time soon?