Latest From Michael McCaughan
The cost of filing a New Drug Application with the US FDA has pushed above the $4 million mark. That is a remarkable rate of increase from the original $100,000 fee set in 1992 – but it does buy a lot more.
Guidance on how to implement a new policy to permit Part D beneficiaries to pay high copays in monthly installments (rather than all at once at the pharmacy counter) shows that there is no such thing as a straight-forward change in the drug benefit program.
The first 10 drugs picked for price negotiation in the US Medicare program will all be unwilling trailblazers. But the position of Abbvie’s Imbruvica stands out as unique in several important ways.
The inaugural class of drugs subject to the new US Medicare price negotiation process includes four antidiabetics. But none are from the biggest and fastest growing class – thanks to few technicalities in how the law works.
The US FDA is free from the need to reconsider Accelerated Approvals in a formal hearing in front of an advisory committee. But now the agency is now trying that approach to hear an appeal of a rejected application.
The US is proposing to pay hospitals extra to maintain reserve supplies of ‘essential medicines’ to help mitigate shortages. But would the plan only make the problem worse?