Whom does FDA serve and protect?
Federal oversight requested
The recent controversy over the safety of Vioxx has opened up the question as to precisely whom the FDA is looking out for, and whether or not there nees to be an independent oversight of the agency:
His explosive remarks — he compared heart attacks allegedly caused by the Vioxx painkiller to ‘aircraft dropping from the sky’ — also now place the FDA under unprecedented pressure to overhaul how it regulates an industry that sells more than $200 billion worth of prescription drugs every year. One idea already gaining steam in Congress is to create an independent panel to oversee the agency’s safety activities.
‘We have a broken system,’ said Raymond Woosley, a respected FDA consultant who was a leader in the successful fight to get the agency to ban the dietary supplement ephedra. ‘At the end of the day, we need someone independent of the process who is involved in safety decisions.’
I agree. Who should do the oversight? I would take a focus group of existing government agencies such as DEA, ONDCP, and NIH and let them re-establish some of the procedures for safety and testing.
I remember when mifepristone was rammed through the FDA. . . there are other drugs that we can mention where sufficient oversight does not exist. At some point, we have to hit the restart button.
EDIT: If you click on the link, the title of the article is “Who does the FDA protect,” which is bad grammar. If the FDA helps him, then you ask whom. Ah, journalists. . .