Latest From Michael McCaughan
The US FDA has promised to hold a public advisory committee review before authorizing or approving any COVID-19 vaccine candidates. What could possibly go wrong?
The US Food and Drug Administration is expediting the review for Biogen’s Alzheimer’s therapy aducanumab, setting up a likely November/December advisory committee consideration that in normal times would be the dominant topic for those who care about the agency.
The US government program that allows safety net providers to purchase drugs at deep discounts is probably not what most American voters have in mind when they say drug pricing is a top issue. But the 340B program has been a rare area of consistent focus – and actual sustained change – in the Trump Administration.
The first virtual US FDA advisory committee review of a drug application was nearly a disaster, but the second proved that the concept can work. Nevertheless, things are going to be very different for sponsors, even when the technology is perfected.
The US Democratic Party will not be rallying around ‘Medicare for All’ in November. But the absence of a push for a single payer system is about the only good news for drug companies in the ‘unity platform’ released by presumptive Presidential nominee Joe Biden and his defeated rival Bernie Sanders.
Joe Biden’s presidential campaign now has a plan to address supply chains and encourage US-based manufacturing of prescription drugs. That affirms the unlikely national prominence of the issue – and reduces the chances of meaningful legislation this year.