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FDA regulators should take page from European handbook

Brian O'Connell on November 04, 2011 Source: Kauffman Foundation

The evidence is mounting that the U.S. Food & Drug Administration is stifling innovation and keeping potentially life-saving products out of the reach of U.S. consumers.

Nobody is saying that the FDA shouldn’t do its due diligence, but the delays – and a creeping sense of “anti-business” sentiment among federal regulators – are working against not only healthcare and medical device companies, but against consumers, too.

Don’t take our word for it – just ask Dr. Scott Gottlieb, the deputy commissioner of the FDA from 2005-2007 and a practicing doctor and current fellow at the American Enterprise Institute.

Gottlieb recently wrote a scathing rebuke of the FDA in a Wall Street Journal opinion column where he says the agency has created a dangerous imbalance between what the government will allow when it comes to healthcare products and services – and what businesses and consumers actually need.

Gottlieb opens his piece with a comparison between Europe and the U.S. on how each handles healthcare product approvals, and says the U.S. is falling so far behind, it’s actually causing the death of thousands of its citizens.

Here’s how Gottlieb lays the problem out:

An aortic valve approved in Europe four years ago will soon be approved in the U.S. Meanwhile, thousands who may have benefited from the device have died. When people age, the main valve carrying blood out of the heart becomes brittle. As this aortic valve narrows, it can cause debilitating heart failure, and even death.

Fixing the problem in the United States requires open-heart surgery. In Europe, the problem can be repaired using a tiny catheter that introduces a replacement valve through an artery in the leg. In July, a Food and Drug Administration advisory panel said this device should also be approved for sale in the U.S. It is expected to reach patients by year- end—more than four years after it first hit the market in Europe.

Gottlieb calls the foot-dragging by the FDA an “all-too-familiar story,” where Uncle Sam sets up obstacle after obstacle to healthcare entrepreneurs, bleeding them of precious time and financial resources, thus making it much more difficult to get products out to market – and not only help consumers, but earn the revenues needed to keep the doors open and the lights on.

Here’s Gottlieb again:

The FDA impedes useful innovations in the U.S.  Entrepreneurs here are forced to test promising medical devices in costly animal studies for years before they can advance their products into clinical trials. When clinical studies get started, the FDA is asking for longer and larger trials that increasingly mirror hurdles proposed for new drugs.

U.S. healthcare entrepreneurs are reacting by taking their products overseas, to more business-friendly bourses in Europe and Asia. Gottlieb states that over 50 percent of all approved medical devices available in commercial markets were first given the green light in Europe. He notes that in 2004, about 87 percent of all medical device studies were conducted in the U.S. Five years later, that number had drifted downward to 45 percent.

In a classic “trigger” effect, PriceWaterhouseCoopers and the National Venture Association reports that the number of newly launched medical device startups fell from 118 in 2008 to 60 in 2010 (undoubtedly that decline was also fueled by the lousy economy). But simultaneously, the cycle times for medical device approvals have lengthened dramatically – especially trial programs. Furthermore, a study from the Boston Consulting Group notes that the European device approval regulations are just as tough and thorough as in the U.S. – they’re just more proficient at it.

While Congress is working right now on legislation that would make the FDA “less burdensome,” Gottlieb says the U.S. government needs to tear a page out of the European handbook and streamline its device and drug approval programs.

But the U.S. had better speed things up – lives and livelihoods are on the line, Gottlieb says:

As for that aortic valve, more than 15,000 patients worldwide will receive the device by the time it’s slated for approval in the U.S. Some Americans healthy enough to fly have sought the procedure in Europe. Tens of thousands of Americans unable to travel, and too sick to undergo open-heart surgery, have died during the intervening four years.

This is no way to run a regulatory process if the FDA is serious about promoting medical innovation and advancing the public health.

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