Latest From Michael McCaughan
The strange politics of prescription drug importation legislation in the US are on display again, this time in the context of the FDA user fee reauthorization bill. Including the topic in the bill is a ‘big deal’ – but probably makes imports less likely.
A US FDA advisory committee review of a novel COVID vaccine candidate from Novavax made one thing very clear: The agency is firmly convinced that when it comes to vaccine options, more is better.
Robert Califf’s second tenure as FDA commissioner already feels different from the first, thanks to a national shortage of infant formula – and an abundance of questions about what FDA could have done to prevent it.
Proposed ‘Quality Management Maturity’ rating system would be a way to be more ‘proactive and rewarding’ rather than ‘punitive’ when it comes to oversight of pharmaceutical manufacturing. The initiative is clearly important to the head of FDA’s drug quality office.
There is certainly some logic to directing the US FDA to create a council of top managers to assure that the Accelerated Approval pathway is used consistently. But it sure sounds like exactly what the agency did with Aduhelm.
The announcement of US FDA Deputy Commissioner’s new focus going forward at the agency may not mean what you think it does. The focus shouldn’t be on what Janet Woodcock is not doing – but on the fact that she is staying on at the agency at all.