“The transition from regulator to advising companies seems logical, but it raises concern as to whether regulators indefatigably act in the public interest,” Bien and Prasad wrote in their analysis.
Despite the small sample size, Prasad said the reviewers covered in his analysis were “probably a representative set” that showed how a “sizable chunk” of FDA medical reviewers went on to work for the industry they once regulated.
The results were valuable too because no other studies had covered this particular ground, Prasad added. Other experts also pointed to the pioneering nature of the study.
“There haven't been any quantitative studies that I know of on the revolving door at the FDA,” said Genevieve Pham-Kanter, an assistant professor at Drexel University and senior fellow at the University of Pennsylvania's Leonard Davis Institute of Health Economics. “Showing these employment transitions is the first step in studying this area,” she added.
To trace where these 55 FDA reviewers ended up, Prasad and Bien cross-referenced an FDA database with other public information from HHS, LinkedIn and PubMed.
Although all of that government information was publicly available, it was “a pain” to access. “It's like eating a pomegranate,” Prasad said, citing 600-page PDFs that were not always searchable and barely navigable websites.
The analysis did not look at whether FDA medical officers worked for the drug industry prior to their government employment. It also did not claim that their decisions to approve drugs were biased in favor of companies viewed as potential future employers, Prasad emphasized.
Drawing a causal link between drug approvals and future employment would be extremely difficult, if not impossible, but Prasad and Bien's findings nevertheless merited further study.
“We would want to look more closely at the firms sponsoring the products that these former FDA staffers reviewed and see if these were where the former staffers are employed,” Pham-Kanter said. “We would also want to think of more direct ways to look for evidence of influence, if any.”
So far, scrutiny of conflicts of interest at the FDA has focused elsewhere—on the coziness of its its commissioner, Dr. Robert Califf, with the pharmaceutical and medical device industries, and on members of its advisory committees, crews of external experts who weigh in on issues like drugs, medical devices and food.
The FDA screens potential members for conflicts of interest, which it defines as being “of a financial nature.” It says it “reviews all financial interests related to the particular topic of a meeting to determine if a conflict exists.”
Nevertheless, Pham-Kanter's research has shown, financial ties do sway these independent advisers. When they have ties to the company sponsoring a drug that's up for review, they are more likely to vote in favor of that firm, she found after examining the votes and reported financial interests of 1,379 such experts from 1997 to 2011. When advisers had ties to multiple firms, experts' votes were not biased, her investigation, published in the Milbank Quarterly in 2014, found.
The FDA says its policies about conflict of interest are sufficient to safeguard the public.
“Employees leaving government for industry is a dynamic that is present across government agencies and is not unique to FDA. The FDA has a strong set of rules in place to ensure that our employees are working in the public interest, not to advantage any company, organization or individual,” said a spokesperson for the agency.
Federal laws and the FDA's own ethics rules cover matters such as outside employment, the spokesperson added. “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.”
The pharmaceutical industry casts ties between the public and private sectors as an opportunity for cross-pollination.
“Expertise in drug discovery, development and regulatory affairs gleaned from both government and the private sector experience can enhance shared knowledge,” said Andrew Powaleny, a spokesperson for Pharmaceutical Research and Manufacturers of America, an industry trade group. “This knowledge can better inform scientific and medical research and enhance predictability for the benefit of patients.”
The revolving door stems not so much from malicious collusion as it does mere pragmatism, Prasad suggested.
The annual salary for an FDA medical officer, who is required to have a medical degree and, sometimes, an active medical license, is $73,846 at its lowest grade. It maxes out $133,444, according to a federal salary chart from January.
By comparison, top executives in the pharmaceutical manufacturing industry on average took home more than $163,000 in 2015, while those in management occupations across the industry made over $140,000, according to the Bureau of Labor Statistics. For physicians and surgeons, the mean annual wage in May 2015 came to $220,920.
When medical reviewers weigh whether to approve or reject a drug, “I don't want them thinking in the back of their mind, I may someday work for Johnson & Johnson,” Prasad said. Particularly for hematology-oncology drugs, whose benefits are often marginal and offer patients a few more months of life, the answer to whether the drug works is a gray zone.
But the FDA's response is to approve a drug that can extend life, Prasad said, “and this is worth billions of dollars.”
