FDA's Job: Minimize Risks Through Education, Regulation and Enforcement

 Will FDA’s Pendulum Swing to the Side of Enforcement and Regulatory Activities?

By Daniel R. Matlis

The June 11 issue of “The New England Journal of Medicine” features an article by newly appointed FDA Commissioner Margaret A. Hamburg, M.D., and Joshua M. Sharfstein, M.D., FDA Principal Deputy Commissioner.

In this article, entitled “The FDA as a Public Health Agency” FDA’s top administrators set forth their vision for the Agency’s role under President Obama: “minimize risks through education, regulation, and enforcement.”

According to the agency’s Top Brass, FDA’s “overriding purpose” is to protect the public health; as a result, the measure of the agency’s success should go beyond the number of facilities inspected or drugs approved.

“The traditional tools of a regulatory agency are regulation, approval or disapproval of applications, and enforcement. As a public health agency, the FDA should always ask whether delays in approval or safety problems can be prevented — a mandate that requires extensive and creative engagement with regulated industries, patient and consumer groups, and others. The FDA should actively pursue opportunities to help advance science in the domains it regulates and address threats to the safety of medical products and food — even if those opportunities and threats lie outside the realm of the agency’s usual routines.”

Expect FDA to play an important Role in HealthCare Reform. According to the Commissioner “FDA should collaborate with the Centers for Medicare and Medicaid Services — one of the largest health care payers in the United States — as well as with industry and patient and consumer groups to explore ways of shortening the time from approval to reimbursement.”

FDA’s Focus:

The FDA is responsible for 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.

The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.


Historically, under Republican Administrations FDA has embraced the tenet of “helping to speed innovations” through policies aimed at encouraging cooperation with the industry.

Democratic Administrations, on the other hand, tend to focus FDA on “protecting the public health by assuring the safety, efficacy, and security…” through enforcement and regulatory activities.

Past performance is no guarantee of future results but… according to Agency sources, in recent months the Agency has hired 450 new investigators and expects to continue this employment trend in the months to come.

Experience shows that more Investigators generally result in higher enforcement and regulatory activities.

© 2009 Axendia Inc.

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