New FDA Leadership Outlines Their Priorities

May 29th, 2009

Posted by: admin

The new Commissioner and Deputy Commissioner of the Food and Drug Administration, Margaret Hamburg and Joshua Sharfstein, outlined their priorities for the FDA in a recent Perspectives article in the New England Journal of Medicine.  Acknowledging the stumbles of the FDA in the last few years, they seem concerned about making sure the FDA is more of a supporter than a hindrance to action in public health and food safety.

“From our vantage point, the recent salmonella outbreak linked to contaminated peanut butter represented far more than a sanitation problem at one troubled facility. It reflected a failure of the FDA and its regulatory partners to identify risk and to establish and enforce basic preventive controls. And it exposed the failure of scores of food manufacturers to adequately monitor the safety of ingredients purchased from this facility.”

Here are some hints at their other agency priorities, which suggest a more active FDA than we have been used to:

“We intend to work closely with the Centers for Disease Control and Prevention (CDC) to identify priority areas for joint action — such as the response to infectious-disease emergencies and outbreaks of foodborne illnesses and the development of safety systems to prevent lethal overdoses and drug interactions.”

“We look forward to working with the National Institutes of Health, the pharmaceutical and biotechnology industries, academic medical centers, and research universities to accelerate the development of cures.”

“To make important new treatments available to patients, the FDA should collaborate with the Centers for Medicare and Medicaid Services [...] as well as with industry and patient and consumer groups to explore ways of shortening the time from approval to reimbursement. One emerging opportunity is the area of personalized medicine, in which the agency should work with scientific leaders on novel approaches to treating illness.”

“In the domain of food safety, a public health approach starts with the use of data to identify the riskiest parts of an enormous and complex system. The FDA should partner with the Department of Agriculture and other federal agencies, states, and other authorities to establish a modern food-safety system focused on prevention of contamination. Working with Congress to modernize food-safety laws, the FDA must strive to build safeguards into every step of the production and distribution process.”

“The CDC and the FDA should also work closely to identify areas of potential progress in nutrition. A laissez-faire approach to nutritional claims can lead to more confusion than understanding. Working with industry and others, the FDA can support efforts to educate the public about nutrition and promote more healthful foods.”

“Globalization intensifies all the challenges the agency faces. With more than 200,000 companies from around the world selling food, cosmetics, or medical products in the United States, a public health framework provides the only viable way of protecting the American public. To anticipate the next import crisis like that involving contaminated heparin, the agency should assess imported products for their potential to cause significant problems.”

The whole article is worth reading, as it includes the Commissioner and Deputy Commissioner’s perspective on public communication of FDA matters.

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