The Food and Drug Administration (FDA) says its rules, along with federal laws, stop employees from improperly cashing in on their government service. But how adequate are those revolving door controls? Science [Science.org] has found that… regular employees at the agency… often reap later rewards—jobs or consulting work—from the makers of the drugs they previously regulated.
FDA staffers play a pivotal role in drug approvals, presenting evidence to the agency’s advisory panels and influencing or making approval decisions. They are free to move to jobs in pharma, and many do; in a 2016 study in The BMJ, researchers examined the job histories of 55 FDA staff who had conducted drug reviews… They found that 15 of the 26 employees who left the agency later worked or consulted for the biopharmaceutical industry.
Science has discovered that 11 of 16 FDA medical examiners who worked on 28 drug approvals and then left the agency for new jobs are now employed by or consult for the companies they recently regulated.
In 2009, for example, an FDA panel weighed whether the agency should approve AstraZeneca’s widely prescribed antipsychotic drug quetiapine (Seroquel) for a wider range of conditions. The panel heard from health policy expert Wayne Ray… who described his research linking the drug to sudden cardiac death when used with certain other medications.
[T]he agency’s then-Director of Psychiatric Products Thomas Laughren, who was instrumental in shepherding Seroquel and similar drugs through the review process and personally signed their FDA approvals… challenged Ray’s results and defended AstraZeneca’s clinical trial findings in the discussion that followed. The company’s “analysis should have been able to pick up a difference in sudden cardiac death, and they didn’t find any difference between drug and placebo,” he said.
AstraZeneca had pooled data from all its trials as though the data were one data set, causing a well-known statistical error called Simpson’s paradox*. To take the company’s conclusion “as definitive” would be “very dangerous,” Ray said…
Ultimately, the committee voted overwhelmingly to advise approval of the drug for new indications and made no recommendation on labeling it to warn about sudden cardiac death. Later evidence showed that the cardiac problems Ray described are real, and in 2011, FDA required adding a warning on Seroquel’s label.
Soon after, Laughren left the agency and formed a consultancy to help psychiatric drug makers, including AstraZeneca, navigate FDA approvals. He did not respond to repeated requests for comment.
In 2012 and 2013, data expert Joan Buenconsejo led FDA’s analysis of medical statistics in drug reviews, including offerings from AstraZeneca. In 2014, she joined the company as a director and biometrics team leader. By 2015, Buenconsejo had already represented AstraZeneca before her former FDA colleagues as the company sought a drug’s approval.
Jeffrey Siegel, who was an FDA staff member specializing in reviews for arthritis drugs, oversaw the 2010 approval of Genentech’s arthritis drug tocilizumab (Actemra). Months later, he left the agency to join the company and its parent, Roche, as director of the division that includes Actemra and related offerings. Siegel represented Roche before his former FDA colleagues when the company sought approval to promote Actemra for new conditions. Last year, he told STAT that the timing of his decision to join Roche and Genentech was coincidental.
Vinay Prasad, a hematologist-oncologist at Oregon Health & Science University in Portland who co-wrote the 2016 study in The BMJ, contends that weak federal restrictions, plus an expectation of future employment, inevitably bias how FDA staffers conduct drug reviews.
“When your No. 1, major employer after you leave your job is sitting across the table from you, you’re not going to be a hard-ass when you regulate. That’s just human nature.“