FDA Chief to Pharma: Let’s Get Cozier
Posted by Marcy Darnovsky June 6, 2007
Biopolitical Times
In the high-profile scandals and regulatory failures that have repeatedly rocked the US Food and Drug Administration in recent years, conflicts of interest with the pharmaceutical industry have often figured large.
But FDA chief Dr. Andrew C. von Eschenbach, who promised he'd clean up the mess when he was appointed by the Bush administration in 2005, told a Congressional briefing last week that his agency needed to collaborate more closely with drug companies. "The point is that we need to look at the role of the FDA in being a bridge to the future, not a barrier to the future," he said.
What is von Eschenbach thinking? The obvious point has been made by a growing number of critics - including prominent medical and scientific figures - that the close ties between the FDA and pharma aren't the solution; they're a huge piece of the problem.
And these cozy relationships persist as a matter of public policy: The 1992 Prescription Drug User Fee Act actually allows drug companies to pay the FDA for its review and approval of new drugs and medical devices. As former New England Journal of Medicine editor Marcia Angell put it in a recent op-ed in the Boston Globe, that legislation "put the fox in the chicken coop" by, in effect, placing the FDA "on the payroll of the industry it regulates."
And then there's the FDA's failure to oversee clinical trials that the drug companies run. According to a senior FDA official quoted in the New York Times, the agency "inspects at most 1 percent of all clinical trials." That scary fact was mentioned in a scary story about the numerous doctors who have been "disciplined or criticized by a medical board" but were later paid by drug makers to direct clinical trials for them. Currently, the FDA doesn't require the companies to tell it about any of these questionable players - even when they discover them falsifying data.
With people like von Eschenbach in charge of government oversight, Big Pharma's "bridge to the future" looks solid indeed.
But FDA chief Dr. Andrew C. von Eschenbach, who promised he'd clean up the mess when he was appointed by the Bush administration in 2005, told a Congressional briefing last week that his agency needed to collaborate more closely with drug companies. "The point is that we need to look at the role of the FDA in being a bridge to the future, not a barrier to the future," he said.
What is von Eschenbach thinking? The obvious point has been made by a growing number of critics - including prominent medical and scientific figures - that the close ties between the FDA and pharma aren't the solution; they're a huge piece of the problem.
And these cozy relationships persist as a matter of public policy: The 1992 Prescription Drug User Fee Act actually allows drug companies to pay the FDA for its review and approval of new drugs and medical devices. As former New England Journal of Medicine editor Marcia Angell put it in a recent op-ed in the Boston Globe, that legislation "put the fox in the chicken coop" by, in effect, placing the FDA "on the payroll of the industry it regulates."
And then there's the FDA's failure to oversee clinical trials that the drug companies run. According to a senior FDA official quoted in the New York Times, the agency "inspects at most 1 percent of all clinical trials." That scary fact was mentioned in a scary story about the numerous doctors who have been "disciplined or criticized by a medical board" but were later paid by drug makers to direct clinical trials for them. Currently, the FDA doesn't require the companies to tell it about any of these questionable players - even when they discover them falsifying data.
With people like von Eschenbach in charge of government oversight, Big Pharma's "bridge to the future" looks solid indeed.