The FDA takes a few steps forward on reforming the protocol of AC panel voting –and which members are allowed to vote based on COI submissions. Good. But what happens next? Following the panel vote, FDA moves into closed session…with no record, no transparency and makes a ‘yeh/nay’ decision on the NDA without a summary finding of who voted, and how and their arguments as to why? Is this reform?
FDA decisions have as much impact on American lives as do Supreme Court decisions –and if the Supremes are obligated to publish a record of their voting and arguments…why not the FDA? Is the FDA afraid of the sunlight?
I’m sure the FDA’s Big Pharma friends would love to know how FDA management voted? As would the media, the Congress and the public the FDA serves.
So unless the FDA is also mandated to cast its votes in an open hearing, these reforms are as suspect as the Complete Response Letter that Dendreon received (and which apparently was far from a complete response).
