Innovation at the Food and Drug Administration

On the interstate, when traffic suddenly slows, often you come across the obvious cause of the jam: a fender bender, construction, a breakdown.  But in trying to understand why the country’s pharmaceutical, biotech and medical device sectors seem to be facing a slowdown in terms of innovation, there is no single cause.

It’s likely that this slowdown is due to a combination of many factors. And while these industries have fared better than others, it is critical for the health and well being of every American that they not just survive, but thrive.

That’s why we want the Food and Drug Administration (FDA) to do everything we can to promote innovation.

Today the FDA is an agency that works with industry to ensure that a wide array of products that improve the lives of millions of Americans are safe and effective. We do that well, and I am personally proud of that.

But we have also been listening closely to companies, patients, doctors and advocacy groups about ways we can help America remain the leader in biomedical innovation. The FDA’s suggestion box is never closed. And, as you can imagine, never empty.

So what are we hearing?

We are hearing that as the science that goes into developing these products becomes increasingly sophisticated, the FDA needs to be just as sophisticated in the way we review these products. And we hear from Americans who want the FDA to work better as one agency, rather than functioning as several semi-autonomous “centers.”

We also hear that we need to do more to help small businesses, companies that are critical to developing the creative, cutting-edge products that represent the very future of the U.S. biomedical industry.

Today I released the “Blueprint to Drive Biomedical Innovation.” It is the result of months of thoughtful internal analysis as to how the FDA can facilitate innovation. But, perhaps more importantly, it is a direct response to an orchestrated campaign of engagement with all of our stakeholders.

Is it the total solution? No. Just as I mentioned there is not a singular cause, there is also not a singular solution. However, this document represents a productive and important first step toward smart innovation-focused reform at FDA.

The future of medical treatments is full of possibilities, and this blueprint offers a look at just how instrumental the FDA will be in making that future possible.

Vicki Seyfert-Margolis is Senior Advisor for Science Innovation and Policy for the FDA Commissioner’s Office.

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