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Stanford physician-entrepreneur discusses need to change FDA approval process


Amid complaints from manufacturers that the federal system for reviewing medical devices lags behind other countries, the U.S. Food and Drug Administration recently announced proposals to streamline the approval process.

In an opinion piece today in the San Jose Mercury News, Josh Makower, MD, a medical device inventor and consulting associate professor of cardiovascular medicine, references the new proposals, which he believes "fall far short of the change that is necessary," and makes some important points about health care innovation and regulation. He writes:

Compared with Europe, delays can be more than five times longer in America. The average American-made medical device is available in Europe two years before U.S. patients have access to it.

The FDA is charged with both protecting and advancing public health. When the FDA denies patients timely access to therapies, they are failing on both fronts.

A study I conducted of more than 200 med-tech firms points precisely to where the system has broken down. The problems stem from a combination of substantial operational inefficiency at the agency -- including staff turnover and administrative delays -- and a deeply rooted risk-averse attitude, where delaying, rejecting or avoiding a decision altogether is considered a better course of action than rendering a positive decision that could later be criticized.

Previously: Stanford Biodesign Program releases video series on the FDA system, FDA walks line between innovation and safety, Brainstorming on how FDA can promote device innovation and FDA launches medical device transparency site
Photo by Steve Winton

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