A new report in the British Medical Journal “reveals” that many U.S. government regulators who review the safety of prescription drugs later go on to work for the pharmaceutical industry.
As opposed to – the automotive industry?
The authors identified individuals working at the FDA who were charged with reviewing hematology-oncology drugs from 2001 to 2010. They identified 55 reviewers. They found that 49 per cent were still employed with the FDA. Of the half that left, 58 per cent had moved on to jobs in the biopharmaceutical industry or as consultants to the industry. They could not find employment information for about 31 per cent of the reviewers who no longer work for the FDA. According to authors Jeffrey Bien and Vinay Prasad, “The transition from regulator to advising companies seems logical, but it raises concern as to whether regulators indefatigably act in the public interest.”
Hogwash.
Here’s what the FDA has to say:
"Federal laws and FDA ethics rules cover issues like outside employment, avoiding real and apparent conflicts of interest, recusals, disclosure requirements, protecting confidentiality, a ban on gifts from regulated industry, and avoiding conflicts should a federal employee choose to seek or negotiate outside employment," the spokesperson said. "Furthermore, past federal employees are bound by additional rules protecting the confidentiality of information they worked on while in federal service, a cooling-off requirement for senior employees, and other important rules against switching sides, contacting former employees, and contacting agency leaders."
And as the Pink Sheet reports:
“Peter Pitts, President of the Center for Medicine in the Public Interest and a former FDA associate commissioner, also slammed the findings of the report. He echoed FDA's comments, while also describing its authors as "ignorant."
"Former FDA employees understand the difference between sharing their expertise with industry and trying to unfairly influence their former colleagues," Pitts told the Pink Sheet. "They are the first to point out their jobs aren't to influence the agency but rather to share how best to properly communicate relevant information, and completely within appropriate limits. Former FDA employees understand the difference between sharing their expertise with industry and trying to unfairly influence their former colleagues. They are the first to point out their jobs aren't to influence the agency but rather to share how best to properly communicate relevant information, and completely within appropriate limits." Pitts added that he has never met a former FDAer "who ever asked for a short cut or an inappropriate edge. Shame on those who would allude otherwise." He further said that people should be applauding the fact that industry, like FDA, is looking to attract "the best and the brightest" to spur innovation.
Any former FDAer who tried to inappropriately influence an agency decision on behalf of a client would become persona non grata – and rightly so. What the authors seem not to understand is that there’s a world of difference between expert navigation and conflicts of interest.
As opposed to – the automotive industry?
The authors identified individuals working at the FDA who were charged with reviewing hematology-oncology drugs from 2001 to 2010. They identified 55 reviewers. They found that 49 per cent were still employed with the FDA. Of the half that left, 58 per cent had moved on to jobs in the biopharmaceutical industry or as consultants to the industry. They could not find employment information for about 31 per cent of the reviewers who no longer work for the FDA. According to authors Jeffrey Bien and Vinay Prasad, “The transition from regulator to advising companies seems logical, but it raises concern as to whether regulators indefatigably act in the public interest.”
Hogwash.
Here’s what the FDA has to say:
"Federal laws and FDA ethics rules cover issues like outside employment, avoiding real and apparent conflicts of interest, recusals, disclosure requirements, protecting confidentiality, a ban on gifts from regulated industry, and avoiding conflicts should a federal employee choose to seek or negotiate outside employment," the spokesperson said. "Furthermore, past federal employees are bound by additional rules protecting the confidentiality of information they worked on while in federal service, a cooling-off requirement for senior employees, and other important rules against switching sides, contacting former employees, and contacting agency leaders."
And as the Pink Sheet reports:
“Peter Pitts, President of the Center for Medicine in the Public Interest and a former FDA associate commissioner, also slammed the findings of the report. He echoed FDA's comments, while also describing its authors as "ignorant."
"Former FDA employees understand the difference between sharing their expertise with industry and trying to unfairly influence their former colleagues," Pitts told the Pink Sheet. "They are the first to point out their jobs aren't to influence the agency but rather to share how best to properly communicate relevant information, and completely within appropriate limits. Former FDA employees understand the difference between sharing their expertise with industry and trying to unfairly influence their former colleagues. They are the first to point out their jobs aren't to influence the agency but rather to share how best to properly communicate relevant information, and completely within appropriate limits." Pitts added that he has never met a former FDAer "who ever asked for a short cut or an inappropriate edge. Shame on those who would allude otherwise." He further said that people should be applauding the fact that industry, like FDA, is looking to attract "the best and the brightest" to spur innovation.
Any former FDAer who tried to inappropriately influence an agency decision on behalf of a client would become persona non grata – and rightly so. What the authors seem not to understand is that there’s a world of difference between expert navigation and conflicts of interest.
