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Brendon Nafziger, DOTmed News Associate Editor | November 01, 2010
Revolving door?
But 510(k) safety data aren’t at the heart of consumer advocates’ concerns. Many feel that FDA’s proposed changes don’t answer one of their biggest worries: what’s seen as a cozy relationship between device companies, lawmakers and regulators. This has real-world consequences for patients, as uncovered by a Wall Street Journal investigation last year. In a January 2009 article, the paper argued that pressure from local politicians and the then-head of the FDA’s CDRH led the agency to clear through the 510(k) process a collagen meniscus device made by the company ReGen, despite objections from some reviewers that it was not “substantially” equivalent to an existing product and that it had safety issues. Ultimately, the Centers for Medicare and Medicaid Services denied coverage to the product, saying the evidence wasn’t in its favor. The FDA is now reconsidering its clearance of the device.
Regardless of whether the device ultimately proves to be safe, the brouhaha brought increased media scrutiny to the way commissioners, usually political appointees, influence the decision-making process at the agency and ties between industry and division directors.

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In fact, virtually all previous directors of the CDRH have taken jobs in the industry after leaving the agency, becoming consultants for big drug firms like Amgen or Wyeth-Ayerst, launching their own consulting firms or even working for lobbies like AdvaMed.
“It’s very rare for a high-level FDA person to retire and never work again,” Zuckerman said. “Definitely there’s a huge revolving door to industry, and that’s where they almost always go.”
Still, this is not to say she’s accusing anyone of corruption, as many of the CDRH directors spent decades working at the FDA or other public agencies, earning much less than they could have in the private sector, Zuckerman said. While the salary of the FDA commissioner is around $153,000 a year, and some employees can earn more than $191,000 under Title 42 policies designed to retain specialists, it’s still far less than they could be making if they were in the industry, in which salaries for many of these officials would be half a million dollars or more, according to The Wall Street Journal.
“Almost anybody who heads CDRH…probably could get a job that pays a whole lot more if they went to industry, and certainly some of them don’t go, or at least stay at FDA for decades, getting paid much less than they could,” Zuckerman said.
And some think the problem with the revolving door is less the corruptibility of FDA staff and more the dysfunction it reveals in our system, that the industry thinks it needs someone intimately familiar with the Byzantine halls of a federal agency in order to get devices approved.