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Angie Drakulich was editorial director of Pharmaceutical Technology.
With another potential "made-in-China" crisis looming over the recall of heparin, critics and the media seem to be waiting in line to take another jab at the US Food and Drug Administration.
Washington, DC (Feb. 29)-With another potential “made-in-China” crisis looming over the recall of heparin, critics and the media seem to be waiting in line to take another jab at the US Food and Drug Administration. Rather than hiding behind FDA’s doors, Commissioner Andrew von Eschenbach took the opportunity to talk to the National Press Club last Friday. In a speech titled “FDA at a Turning Point: Meeting the Challenge of a Rapidly Changing World,” Von Eschenbach addressed head on FDA’s faults and what’s needed to “re-create” the agency.
“Changes in our world are affecting every single American in terms of our health and well-being,” he told the audience. “Change is affecting everything from the food we eat to the drugs and medical devices we depend upon. These changes are impacting the Food and Drug Administration and our ability to continue to fulfill our mission to protect and promote the health of every single American.”
The Commissioner discussed how advances in science and technology, along with transportation, information, and globalization, have impacted health. “The simple truth as I see it today is that the FDA of the 20th century is not adequate to regulate the food and drugs of the 21st century.”
He went on to describe the larger-than-life agenda set before the agency, whose staff and resources continue to be overloaded and underfunded. The American public sometimes forgets that FDA is in charge of regulating nearly all the food we eat, vitamins and dietary supplements, all types of medical products from aspirin and biologics to cardiac pacemakers and surgical masks, radiation-emitting equipment such a microwaves, cosmetics, and typical drugstore items such as toothpaste and deodorant. This list doesn’t even include the products FDA regulates for animals such as products from pet food.
To keep up this work in an efficient manner and meet growing demands, Von Eschenbach outlined a five-step transformation the agency has gone through-and will continue to go through-over the past two years. These steps are outlined below.
In further collaborative efforts, Von Eschenbach discussed a new “FDA beyond our Borders” program. This effort is meant to give the agency a greater presence and capacity abroad, starting with China. Four other regions will be targeted as well: India, the Middle East, Central America, and South America. The initiative will allow FDA to “regulate products where they are produced, before they arrive at our borders,” by expanding interaction with foreign regulators, among other things, he said. The same life-cycle approach will be applied to imported products with a focus on new products and high-risk products.
The work of the US Working Group on Import Safety, chaired by Health and Human Services Secretary Mike Leavitt, played a role in the “beyond borders” program idea. The working group was established last spring after several reports of contamination were tied to products made in China.
All of these efforts are meant to “re-create” and improve the agency in a way that “enhances discovery, development and delivery of lifesaving products,” Von Eshenbach said in his closing remarks. “I am aware of the need for radical and rapid change.”
Read Von Eschenbach’s full speech.