What to Expect from FDA in 2010

By Daniel R. Matlis
Adapted from an article published in MedicalDeviceSummit.com

FDA, like any other organization is comprised of people driven by collective goals, a mission and vision. The Agency’s mission is “protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.”

Whenever I have interacted with FDA officials, there is a palpable pride and passion for the Agency’s mission. As one FDA official commented during his remarks at Advamed 2009, “we certainly don’t do it for the money.”

The FDA’s role under President Obama is clear: “Minimize Risks Through Education, Regulation, and Enforcement.” (See report on the then newly appointed FDA Commissioner Margaret A. Hamburg, M.D., and FDA Principal Deputy Commissioner Joshua M. Sharfstein, M.D., and their vision for the Agency in June 9, 2009 article in Life-Science Panorama).

At recent industry events, we have seen clear evidence that this vision, as set forth by FDA’s new leadership, has been willingly embraced by personnel throughout the Agency. This was especially true of the “increased enforcement” theme.

During his keynote address at Advamed 2009, Dr. Sharfstein stressed: “the key challenge facing the Agency is credibility. The Commissioner will restore the Agency credibility with a three-pronged approach that will increase transparency, enforcement and integrity of scientific decisions.”

So what can we expect from FDA in 2010? I wish I could predict the future…
Nevertheless, based on the priorities and drivers set forth by FDA’s leadership, I provide my professional opinion:

  • Higher morale and job satisfaction
  • Increased regulatory enforcement
  • New tools to enhance transparency
  • Opportunities to challenge agency decisions based upon scientific data
  • A drive to operate with the highest level of integrity

Time will only tell how the FDA’s current vision will affect industry and consumers. I look forward to providing you my thoughts and insights in 2010.

Seasons Greetings and Best Wishes for a Successful 2010

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