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May 22

Improve Patient Care by Creating a 21st Century FDA

by Wayne W. Oliver, Vice President, Center for Health Transformation
Originally published in the Atlanta Journal Constitution on December 7, 2011

The U.S. Food & Drug Administration (FDA) regulates virtually everything that Americans consume or put on their bodies. Those FDA-regulated products account for about 25 cents of every dollar spent by American consumers each year — products that touch our lives every day.

But there is a problem. The FDA is trying to do its job with 20th Century tools, technology, culture, and regulatory approach. Innovation is driving 21st Century medical breakthroughs but the FDA does not have the capacity or the capability to help bring these breakthroughs to the American people.

But it gets worse. If we do not transform the FDA, there will be significant consequences. Currently, more than half of the population has at least one chronic disease.  Bringing new, innovative treatments to market for diseases such as cancer, diabetes and heart disease will have tremendous human and economic benefit.

The Partnership for Chronic Disease indicates that chronic diseases kill more than 1.7 million Americans per year and are responsible for seven in 10 deaths, by far the leading cause of death in America. And, chronic diseases also account for 75 percent of the nation’s health care spending.

A 21st Century FDA should lead a revolution in science and medicine which offers medical breakthroughs to help every American prevent and/or manage chronic disease.

Because the FDA is trapped in the 20th Century, the biomedical community is taking investments in innovation to other countries. The FDA’s lack of a transparent, predictable and efficient regulatory pathway has resulted in a dramatic decline in private sector investments in new pharmaceuticals or medical devices, for example, that could save lives.

As a result of the FDA’s regulatory climate, companies have moved offshore to develop important new medicines, taking with them jobs, financial capital and intellectual property. In February, Pfizer announced the planned closure of their US antibacterials unit. Some 1,100 jobs are to be eliminated over an 18-month period as the facility moves to China.

At the Center for Health Transformation (CHT), a two-year project was launched in 2009 to make recommendations on how to create a 21st Century FDA. A couple of our recommendations include:

 Congress should provide the FDA with adequate resources to allow the Agency to be more efficient, more transparent, more predictable, more evidence-based, and more responsive in bringing medical breakthroughs to the American people.

 The FDA should create a new accelerated, patient-centric “conditional approval process.” This new flexible regulatory pathway would bring promising new and innovative medical therapies, treatments and devices to patients more rapidly.

With a more responsive, predictable, transparent and proactive FDA that allows American innovation to stay in our country, we will save lives, improve healthcare and save money.

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