The FDA isn’t capable of living up to its mandate to balance risk and safety for patients, according to medical device legend Dr. Tom Fogarty, a serial medtech entrepreneur who’s also a consultant for the federal watchdog agency.

Speaking alongside Boston Scientific (NYSE:BSX) co-founder John Abele at this week’s AdvaMed 2012 conference in Boston, Fogarty said even doctors sometimes have difficulty figuring out whether a patient will benefit from a certain therapy.

"The fact is that we as physicians have a hard time, in some situations, determining what a risk is and what a benefit is, and when it will work for 1 patient but it won’t work for another patient," Fogarty said. "And to think that an outside agency is prepared to do that is just wrong. They can’t do that. … The changes to technology outpace the ability of FDA and [the Centers for Medicare & Medicaid Services] to keep track of it."

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Asked if the FDA isn’t, in fact, a surrogate for protecting patients, Fogarty’s initial answer was succinct.

"Bullshit," he said. "Patients should have a choice about their therapy. They aren’t considered very often in that. Many times patients will accept different risks, and efficacy can be different with different patients. These patients are not stupid. They may make mistakes, but we as physicians make mistakes."

Abele said that patients in today’s healthcare landscape are treated as "spectators in their own care."

"There’s a sort of, ‘Leave the driving to us’ concept," he said. "There’s a huge range of patient knowledge. And in fairness to the critics who say the patients won’t understand – and they really are spectators in their own care – that’s true, but it’s true because we haven’t made the effort to educate them.

"I look at the FDA as ‘they is us.’ At the end of the day, their job is to balance that risk and reward thing, but they have another audience that’s watching them closely and that audience – Congress – has a great way of really pushing it toward the ‘avoid risk’ side of the equation. That’s what we need to change," Abele said.

Fogarty added that the regulatory pathway in the U.S. has gotten too long and too expensive to allow for the development of truly innovative medical technology.

"The regulatory route now in devices is probably 7 to 10 years. A startup can’t afford to do that. Most of the major innovations come out of startups, not large companies," he said. "Well, if you can’t fund them, guess what? There’s going to be no startups in the U.S., or they’re going to go offshore – which they’re doing with increasing frequency. That is bad for our economy, but the worst thing is it’s bad for our patients.

"Safety and efficacy, that’s what industry wants. They are not going to put out a product that’s not safe and effective. If they do, they won’t be in business very long," he added.