FDA reform in wake of the Bush years

It is important to understand that politics influences even regulatory agencies such as the FDA.  While it would be wonderful if the FDA always based its decisions solely on accurate scientific information, it is dangerously naive to believe this.

This article from Heartwire discusses the Bush administrations influence on the way the FDA operated and whether or not the people appointed by the Obama administration will be able to bring about true reform.

Did a former consulting scientist at the US Food and Drug Administration (FDA) lose his position—as he contends—because he blew the whistle about the risk of radiation exposure from computed-tomography (CT) scanners? Or is the FDA right when it claims that the Department of Health and Human Services (HHS) found no criminal wrongdoing after investigating the charges of Dr Julian Nicholas (Scripps Clinic, San Diego, CA), who testified March 30 at an agency hearing on preventing unnecessary radiation exposure from medical imaging?

While all the facts surrounding the case of Nicholas have yet to be sorted out, some FDA watchers say one thing is clear—the agency is still recovering from the antiregulatory, probusiness climate of the George W Bush administration, in which public health took a back seat.

Dr Steven Nissen (Cleveland Clinic, OH), a long-time FDA critic, has one theory.

“I believe the agency lost its way during the Bush years,” Nissen said in an interview. Nissen sees promise in the two people President Barack Obama picked to salvage the agency—FDA commissioner Dr Margaret Hamburg and principal deputy commissioner Dr Joshua Sharfstein.

“Hamburg and Sharfstein are exceedingly well-intentioned,” said Nissen. “They are very independent and unlikely to be influenced by political considerations. They’re a step up in quality compared with what we’ve seen over the past decade.

“But it’s challenging for the new leadership to turn this giant battleship around when so many people in the infrastructure don’t have a public-health perspective.”

Dr Diana Zuckerman, president of the nonpartisan National Research Center for Women and Families, which specializes in health issues, agrees. “The new leadership of the FDA inherited a mess,” she said. “You have a change of leadership at the top, but the vast majority of the people in the FDA at the office or center level are exactly the same [as before].

“People got promoted during the eight years of the Bush administration for reasons that had to do with ideology. They may be very capable and smart, but they also have a proindustry point of view, not a public-health point of view.”

much more via FDA reform in wake of whistleblower testimony.


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