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May 23

First things first: Fix the FDA

by Newt Gingrich, Andrew C. von Eschenbach, MD and Wayne Oliver
Originally published by The Hill on February 11, 2011

President Obama in his State of the Union speech said he wants to stimulate the economy by spending billions of dollars for research and development and create a new federal agency called the National Center for Advancing Translational Sciences at the National Institutes of Health.

At the Center for Health Transformation, we are passionate supporters of biomedical research and join others in applauding that well-intentioned idea. Unfortunately, it is probably doomed to fail.

If we are to invest taxpayer funds, the American people expect us to invest their money wisely. In this case that means assuring that investments in research will result in products that improve the lives of the people making that investment. The administration’s proposal is worse than building a bridge to nowhere; it is investing in a road that cannot reach its destination because there is no bridge. The “bridge” from investments to discovery and development to delivery to the American people is the Food and Drug Administration (FDA).

Historically, the National Institutes of Health (NIH) has focused on basic scientific research while the pharmaceutical and biotechnology companies have then taken that basic scientific research to create and develop new drug products. Every single drug, vaccine, biologic and medical device must be approved by the FDA before it can ever be offered patients.

Over the past 20 years, despite hundreds of billions of dollars invested in biomedical research by the NIH and industry, the FDA has approved fewer and fewer new medications. In 2010, only 21 new medications were approved by the FDA which was the fewest number of new drugs approved by the FDA since 2007, when there were 17.

If science and technology are advancing, then why are there fewer new drug products being approved? The problem is not that we are underfunding research and development but rather we are ignoring the critical role of regulation and not addressing the fact that the current FDA is woefully inadequate for the challenges and opportunities of the 21st Century.

So, creating a new federal agency to accelerate new drug discovery only to see those new drug products languish under antiquated and inane FDA regulations makes no sense whatsoever. We need to upgrade and modernize the current FDA instead.

The FDA’s current regulatory path way is broken and costs American lives, and deprives millions of people of life-saving and health-enhancing new and emerging therapies.

Not surprisingly, the pharmaceutical and biotechnology industries have responded to a non-responsive FDA by taking their research and development investments to a better regulatory climate. More specifically: those jobs, those funds, those R&D investments are now flowing into Europe and Asia.

Congress is currently engaged in discussions of reauthorizing the role and responsibilities of the FDA. At the Center for Health Transformation, we are working to help identify solutions to modernize the FDA and define strategic opportunities to make the FDA regulatory process more efficient, transparent, predictable and rigorous.

The President and the administration want the right outcome but have the wrong diagnosis and treatment. While we are certainly not opposed to accelerating the development of new, life-saving remedies, the problem is more complicated than simply creating a new federal agency or yet another federal bureaucracy.

We need a more flexible, intuitive, predictable, responsive and transparent FDA that is in tune with the 21st Century. We need an FDA that understands the importance of encouraging the investment in the development of new medications and devices which can save lives, improve the quality of life and diminish the impact of disease.

The current regulatory environment impedes progress, discourages innovation, destroys jobs and undermines our economy. Increasing investment in research and development for the discovery of new drugs is laudable but only after the FDA goes through a comprehensive structural and functional overhaul. Congress and the Obama administration would be well advised to focus first on modernizing, improving and transforming the current regulatory process within the FDA.

Gingrich, former Speaker of the House, is founder of the Center for Health Transformation. Von Eschenbach is the former Commissioner of the Food and Drug Administration. Oliver is a Vice President at the Center for Health Transformation. The Center for Health Transformation is an organization dedicated to transforming health and healthcare in America to save lives and save money.

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