Republicans, CEOs Blast FDA's Medical Device Review Process

Posted 04 October 2012 | By Alexander Gaffney, RAC 

Republican members of the House Energy and Commerce Committee (E&C) recently took aim at the US Food and Drug Administration's (FDA) medical device approval policies, calling for the agency to get products to market more quickly after hearing concerns raised by a number of executives.

At a meeting with a handful of medical device CEOs entitled, "Jobs and Innovation Forum on Medical Devices," the congressmen took aim at FDA, and in particular its medical device regulatory division, the Center for Devices and Regulatory Health (CDRH).

The industry is threatened, said Rep. Cathy McMorris Rodgers (R-WA). "It's threatened directly by FDA and its bureaucracy. It's threatened by costly, cumbersome regulations."

She claimed that many companies are already moving their operations overseas and are seeking to enter foreign markets before the US in light of what they perceive to be an unpredictable and time-consuming regulatory environment.

Alex Lukianov, CEO of NuVasive, a medical technology company focused on minimally invasive back pain products, agreed with Rodgers' assessment. "We've had to put off on the hiring of about 150 employees this year because [several] products did not make it to market," he said. "This is not an issue of safety or efficacy," he added. "These are safe and efficacious products that are really being caught up in the quagmire of the regulatory process, with constant requests for more information and more tests that don't have a clinical bearing."

Companies Look Overseas

"These things have had a pretty big impact on our company," said Lukianov. "We now have an FDA that is really not allowing us to get our products out any longer."

"We used to introduce 100% of our devices in the US first," said Steve Ferguson, CEO of the Indiana-based medical device manufacturing giant Cook Group. Now, he said, nearly all of its products are first approved outside the US, typically two or three years before they are introduced in the US.

"The system needs to be changed" at FDA, added Ferguson.

Lukianov put forth a series of suggestions, including additional training for CDRH reviewers, reducing agency turnover and ensuring the consistency of review standards.

"If you agree on a particular protocol, you can't have that change in three or four years," in the middle of a product's development cycle, said Lukianov, hedging that safety issues are the exception to this rule.

"A lot of times you don't get any information back from FDA until it's very late in the game," continued Lukianov.

"I think they have to take very seriously the power they have over a company. Yes, they have to look at safety and efficacy. But I don't think a reviewer should have the power to ask for whatever he or she wishes from a company when it can lead to spending a hell of a lot more money to do the testing or even bankrupt a company."

Regulatory Flexibility Floated

Ferguson also called for additional reliance on international regulatory findings, particularly testing conducted abroad. "We ought to rely more on international standards. You shouldn't have to re-prove something."

"If you're on the government side, it doesn't make any sense for us to re-do animal tests that other companies have already done," he added.

Ferguson said he agreed with Lukianov on many points, including his calls for a more predictable regulatory system in regard to agreed-upon protocols. Both CEOs also agreed that individual FDA employees were not the problem, but rather attributed problems to entrenched and systemic problems.

Other CEOs attributed the problems to the agency's general sense of risk aversion. Rick Packer, CEO of Zoll Medical, acknowledged that any perceived agency mistakes would likely result in individual reviewers and directors being dragged before Congress and potentially excoriated.

"In certain political environments, FDA gets very, very risk averse," said Packer. "They're very averse to coming before Congress and having to explain why such-and-such a device didn't work perfectly every time. I think culturally, that weighs down the agency and acts to really seize it up."

"People are afraid to make a decision," he continued. "It's safe if you don't put a product on the market. No one can ever second-guess your decision not to."

Lukianov also called on Congress to develop a system with a European-style medical device review program-a potential non-starter in Congress given the European Medicines Agency's own attempts to reform the system to institute further checks and balances in the wake of a prominent scandal.

"I think that the EU system has a lot to offer in terms of its philosophical orientation that we could apply to FDA and to make it more risk averse," he said. "All these added layers that we're forcing companies to do is accomplishing nothing" relative to the EU, he added.

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