That's the pithy headline Merrill Goozner came up with to describe the appearance yesterday byRandall Lutter, the FDA's deputy commish, before a House subcommittee that was holding a PDUFA hearing. Randy, it seems, was "woefully unprepared" to address a few of the day's pressing issues, according to Goozner, who heads the Integrity in Science project for the Center for Science in the Public Interest. For instance, he writes this....
"The most entertaining back-and-forth involved Rep. Diane DeGette (D-CO), who at a previous subcommittee meeting had asked the FDA for some data involving medical devices. They were supposed to have responded in writing within a few weeks of the hearing â€“ a typical response at Congressional hearings when the witness canâ€™t immediately put his hands on the information being requested. A month ago, DeGette wrote a follow-up letter asking "where's the data?" When she brought that letter to Lutterâ€™s attention today, he admitted that he hadnâ€™t read it because he hadnâ€™t seen it."
"Rep. Jan Schakowsky (D-Ill.) asked Lutter about the recent case involving the scientist who tried to issue a warning about Avandia a year ago, but was told by her higher-ups at the agency to sit down and shut up. Schakowsky also mentioned the case of David Ross, who recently departed for the Veterans Administration after blowing the whistle on Ketek, an antibiotic with dangerous side effects.
â€œWe take these concerns very seriously,â€ Lutter said. â€œI am unfamiliar with their cases.â€
Hard to believe. Randy, a former fellow at the American Enterprise Institute, may not know every detail, but he's the deputy commish. He ought to know enough to provide a proper response to the public. He needs to get up to speed. And he also needs to pay more attention to his mail.
You can read more here.