March 22, 2007 – 4:52 p.m.
Food and Drug Administration Commissioner Andrew C. von Eschenbach amiably shied from policy remedies Democrats urged on him at a House hearing Thursday on drug safety while trying to assure them he will protect the rights of employees who blow the whistle on drug hazards. But Democrats didn’t seem to believe him and one whistleblower in attendance said he had failed.
Democrats at the Energy and Commerce Oversight Subcommittee hearing pressed von Eschenbach on a variety of measures designed to prevent a repeat of the agency’s months of inaction on hazards linked to the painkiller Vioxx, which one agency whistleblower tied to thousands of deaths.
Among the possible steps were giving FDA stronger authority to order drug labeling changes, enforcing requirements for post-approval safety studies, vigorously regulating direct-to-consumer drug advertising and establishing an independent office of drug safety at the FDA.
“I don’t think you have sufficient authority but I also think you don’t have sufficient resources,” California Democrat Henry A. Waxman said. He emphasized that the FDA lacks an effective way to ensure that companies perform the post-approval safety studies the agency makes a condition of approval in many cases. The only remedy now is to force the drug off the market but that is so severe a step the agency ignores it, he said.
Meanwhile, companies drag their heels on hundreds of studies, he said. A 2006 FDA listing of some 1,200 post-marketing studies shows that only 11 percent have been completed, Waxman said.
Von Eschenbach agreed up to a point. “I concur that this is a process that definitely needs improvement,” he said, but “the opportunity to enforce compliance is ultimately there.” The FDA commissioner said one tool the agency has is to publicize companies’ failure to complete studies. Von Eschenbach didn’t specify how often that is done, other than to say the agency prepares an annual report given to Congress summarizing the status of post-marketing studies.
Waxman also suggested that the ability of companies to “oversell” drugs through TV ads leaves the public unnecessarily exposed to drug hazards. He added that enforcement activity targeting misleading ads has trailed off sharply under the Bush administration. “Even repeat offenders face no sanctions,” Waxman said. “I’m concerned about the ability of your agency to oversee the ads.”
Von Eschenbach said legislation reauthorizing FDA’s prescription drug user fee system will devote more resources to overseeing drug advertising. But Waxman countered that much of the problem is FDA’s unwillingness to prosecute companies for violations it does find.
Von Eschenbach opposed the creation of an independent office of drug safety, saying the public is better protected by continuing to “integrate” drug safety functions with reviews of new drugs.
But testimony by the Government Accountability Office said that the “FDA has not improved its process to resolve disagreements over safety decisions.” The GAO added that the agency is developing but hasn’t completed guidance to clarify the role of the drug safety office in scientific advisory committee meetings.
Republicans at the hearing expressed caution about overreacting to safety concerns by delaying essential access to new drugs. But they joined Democrats in expressing concern, although more gently, about whistleblowers.
Some of the sharpest criticism leveled at von Eschenbach related to statements attributed to him that critics claim are an attempt to silence whistleblowers. Energy and Commerce Chairman John D. Dingell, D-Mich., noted in his opening statement that “we have heard testimony that the commissioner told . . . employees that anyone not willing to be a ‘team player’ would be traded.
“Given that their protests went to congressional offices, including this committee, I must remind the commissioner that threatening FDA employees with retaliation for talking to Congress is not only unacceptable, it is illegal,” Dingell said.
Von Eschenbach insisted his statements have been misquoted or misinterpreted. He said he favors a “transparent” but “disciplined” regulatory process in which every employee has the right — even the duty — to vigorously express dissenting positions on scientific issues. But when employees choose not to participate in that debate and then express their views independently, “I don’t think that’s helpful to the process,” he said.
Von Eschenbach also described a June 2006 meeting with agency employees in which he used a locker room analogy to describe his views on how dissent should be freely expressed but kept inside the agency as a morale-building attempt.
Former FDA employee Dr. David Ross told reporters during a break in the hearing that he was at that meeting and von Eschenbach said those who go outside the agency would be spoken to the first time, benched the second time, and traded the third time.
Ross said he tried to express his concerns about the safety of the antibiotic Ketek internally but a superior “blew it off.” Ross said, “I went inside the agency . . . and nothing was done.” Statements by von Eschenbach about dissent being destructive under certain circumstances continues to send a “disturbing message” to FDA employees, he said.


