Prescription Drug User Fee Act-Drug Approval Process-Medical Device-Congress-FDA

Bipartisanship in Congress, in Support of Pharma and Device Industries

It's often said today that Congress is totally dysfunctional and cannot agree on anything due to the huge partisan culture war. Well, the good news is that there's bipartisan cooperation on at least one issue. The bad news is that it's all in favor of handing the foxes at the pharmaceutical and medical device industries the key to the FDA henhouse. 
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

Gooz reports that consumer advocacy groups are incensed over these concessions but are getting nowhere with Congress.
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). read more..