Wednesday, September 7, 2011

FDA’s Work IS Essential

By Margaret Anderson, Executive Director, FasterCures
“The U.S. Food and Drug Administration provides essential benefits to consumers and patients, and there is no backstop, no other agency, that performs this critical work.” –Alliance for a Stronger FDA* ad, September 2011
No other agency touches American lives daily – consider the products we consume the first 30 minutes of each day– the list of products regulated by this one agency is long. And yet, despite such big responsibilities, its budget has not always kept pace.

As the US Senate Appropriations Committee considers funding levels for the agency. Here’s hoping that the Committee consider the vast needs of this chronically underfunded, but critically important entity:

- Increased funding at the FDA will allow the agency to bolster its scientific infrastructure and expertise and be able to more effectively take the baton of medical innovation from the medical research community and bring it into the marketplace, where scores of patients impatiently await access to potentially life-saving therapies and life-enhancing scientific advances.

A few weeks ago, FDA provided details on exactly how it will go about doing this through its strategic plan for regulatory science. Priorities include stimulating personalized medicine programs, developing medical countermeasures to protect threats to global security, and ensuring agency capability to evaluate new, innovative technologies.

In an editorial in The Wall Street Journal, FDA Commissioner Margaret Hamburg said that the agency is “actively taking steps to improve the clarity, consistency and predictability of our regulatory systems. At the same time, we are working with the broader scientific community to address issues of scientific uncertainty that slow medical-product development and review.”

- Increased funding at the FDA will support industries that are essential to our nation’s growth and prosperity and create high-paying American jobs. Consider that the bioscience industry, which depends on FDA for regulation of its medical device and therapeutic products, directly employed 1.42 million people in the United States in 2008 and generated an additional eight million related jobs**.

An FDA that’s functioning at peak performance can spur economic growth and accelerate the process of bringing to market promising breakthroughs that can help improve the quality of life, and even save lives.

*FasterCures is a member of the Alliance for a Stronger FDA. Margaret Anderson, FasterCures executive director is the Alliance’s vice president.
** The U.S. FDA: A Cornerstone of America’s Economic Future

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