June 07,2007

New questions about FDA attempt to denigrate doctor with concerns about drug safety

WASHINGTON — Leading lawmakers today called on the FDA Commissioner to explain the agency’s policy on conflicts of interest regarding staff hired directly from pharmaceutical companies that are regulated by the FDA.

They made their inquiry based on the actions of an FDA spokesman, who previously worked for multiple pharmaceutical companies. The FDA employee used agency email to attack the research of an independent scientist. Yesterday, the FDA Commissioner testified that the employee had been formally reprimanded with a letter in his employment file.

The letter is signed by Sens. Chuck Grassley, Max Baucus and Sherrod Brown, as well as Reps. John Dingell and Bart Stupak.

“After all the talk of reform by the FDA commissioner, it’s discouraging and alarming to see another situation where you can’t tell the difference between the actions of the FDA and those that might come from a drug maker it’s regulating,” Grassley said.

“The opinions of independent scientists must be valued by the FDA,” said Baucus. “Objective, outside advice is essential to protect Medicare and Medicaid patients—and all Americans—from drugs that could turn out to be harmful. I have some serious questions about Mr. Arbesfeld’s use of government resources, but I am even more concerned about whether his drug company connections led him, in any way, to seek to unjustly discredit Dr. Nissen. The FDA’s ultimate duty is to ensure the safety of the products it regulates, which includes sharing credible, potentially life-saving information from any trustworthy source.”

“The FDA should thank doctors who identify potential health risks, not demonize them. Congress is working on legislation to clean up FDA’s act, and none too soon,” Brown said.