Regulatory Focus™ > News Articles > FDA and the Public Interest: The Problem With Drug Reviewers Moving to Industry

FDA and the Public Interest: The Problem With Drug Reviewers Moving to Industry

Posted 28 September 2016 | By Michael Mezher 

FDA and the Public Interest: The Problem With Drug Reviewers Moving to Industry

A new analysis published in The BMJ finds that more than a quarter of hematology and oncology drug reviewers at the US Food and Drug Administration (FDA) left the agency to work or consult for the biopharmaceutical industry between 2001 and 2010.

"We are concerned by these findings," write Dr. Vinay Prasad and his colleague Dr. Jeffrey Bien at the Oregon Health & Science University, "The transition from regulator to advising companies seems logical but it raises questions as to whether regulators indefatigably act in the public interest."

According to Prasad and Bien, the issue of the so-called revolving door between government and industry is widely known, but had not been previously quantified in relation to FDA reviewers.

To conduct their analysis, Prasad and Bien identified some 55 reviewers that worked on new hematologic or oncologic drug approvals between 2001 and 2010 using data from FDA's medical reviews.

"We focused on hematology-oncology drug reviewers because of our knowledge of this area, because more hematology-oncology drugs are approved than any other class of medicines, and because the approval of cancer drugs with small or marginal benefits and toxicity has increasingly fallen under scrutiny," the authors write.

Of the 55 reviewers identified for the ten-year period, roughly half (27) were still employed at FDA when the authors ran their search of Department of Health and Human Services (DHHS) personnel data, PubMed, LinkedIn and biopharmaceutical company websites between December 2015 and February 2016.

However, of the remaining 26, the authors found that 15 had taken up jobs or began consulting for the biopharmaceutical industry. Additionally, the authors say this figure is probably low, as they were unable to determine where eight of the 55 reviewers were employed.

"If anything, we underestimate the extent of this phenomenon, as not all reviewers' future careers could be identified," the authors write.

Revolving Door in Europe

Across the Atlantic, the European Medicines Agency (EMA) has instituted policies to rein in, or at least get a handle on, employees leaving the agency for work in industry.

Under EU staffing regulations, ex-EU agency employees are required to inform their former employers of any new occupational activity they engage in for two years after leaving the agency.

"The purpose of this provision is to allow the agency to assess whether there might be a potential real or perceived conflict with the interests of the agency," EMA writes in its Best Practice Guide for Staff Leaving the Agency.

Under the policy, EMA's Executive Director can bar former employees from undertaking certain employment activities if they relate to work the employee did within their last three years at the agency.




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