Interview with FDA Watchdog, Senator Chuck Grassley

 Grassley The Boston Globe just ran an interesting interview with Chuck Grassley, the Iowa Republican senator and self-designated FDA gadfly. Below, an excerpt: "...Armed with insider information from whistle-blowers, Grassley says he is trying to prod the agency to change a culture that stifles and punishes dissenters. He has exposed internal FDA memos, e-mails, and conversations to unprecedented public scrutiny. Sunlight, he is fond of saying, ``is the best disinfectant." Grassley said the FDA watchdog role is natural for him as Senate Finance chairman with oversight over Medicare , a program that spends heavily on prescription drugs. ``I've got absolutely every reason in the world to make sure that the Medicare tax dollar buys a safe and effective drug," he said. The fifth-term senator rarely pulls the curtain of anonymity with an off-the-record reply. His ready answers can be as short and precise as his graying hair. And if his memory is occasionally less than perfect, it doesn't seem to cause him concern. In the ``Eye on the FDA" column on his website, Grassley says, ``I have made it my business to meddle pointedly within the muddle of the federal bureaucracy." He feigned ignorance when asked about the statement, but if his site says he's a meddler, he allowed, it must be true. When it comes to Congress, he has a sharp view of its two major functions. ``One, to pass law, and the other one, to make sure the laws are faithfully executed," he said. ``We put too much emphasis on the first one. I don't care about that as much as I do oversight." He has invited FDA and business whistle-blowers to Congress to testify and used their insider knowledge to obtain more information. ``There is no way I would have the resources to go out and find these things we find. People bring them to me," he said. ``That's why whistle-blowers are such an important part of representative government and oversight. They know where the skeletons are buried." A recent bill Grassley cosponsored would bring that same kind of transparency to clinical trials by mandating publication of results. A more disputed proposal he cosponsored would create an autonomous Office of Drug Safety at the FDA, separating drug safety reviewers from the Office of New Drugs . A Government Accountability Office investigation of drug safety, requested by Grassley, found the current FDA office responsible for drug safety is under-funded, subject to high turnover, and routinely ignored. ``The way our bill is written, I think it's going to demand more resources. But right now, we've got to get it out with more independence," Grassley said. Some say his efforts could be the solution to what ails the FDA; others think he's part of the problem." What do you think? -AMS