The estimable Merrill Goozner: http://gooznews.com/?p=3914--has blogged about the latest renewal round of the Prescription Drug User Fee Act, where drug firms agree to pay a lot of the freight for running the FDA's drug approval process, and almost always manage to wring out favorable concessions in exchange for their largesse. Among the Christmas list the industry wants this time, and that Congress, well primed by the lobbyists, is apparently ready to hand them, are:
- More use of surrogate markers to approve new drugs, without demanding proof that the actual diseases that affect people get any better (e.g., a drug that lowers blood sugar but does nothing to prevent heart attacks or strokes or blindness from diabetes)
- Complete gutting of the reforms called for in the recent Institute of Medicine report to toughen requirements for testing new devices for safety
The solution, as we have known for a good while, is to stop depending on the drug industry to fund the FDA--though replacing drug bucks with taxpayer bucks won't make that army of lobbyists go away (meaning that at some point or other, campaign finance reform is desperately needed as well).
NOTE ADDED 5/18: A kind colleague at Consumers Union just sent me two links that are very useful in relation to this issue-- first, a Public Citizen fact sheet regarding device regulation:
--and next, a Twitter discussion from the Safe Patient Project at Consumers Un ion regarding the pending legislation in Congress and how it fails to protect patients: