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Groups Urge Change at FDA

Mar 26, 2009 | Parker Waichman Alonso LLP

Following President Barack Obama’s announcements that two health specialists would be appointed to key positions at the  the Food and Drug Administration (FDA), and that a new group would be appointed to look at reforming food safety laws, two advocacy organizations are urging Obama’s administration to appoint a senior food safety official in the FDA.

Earlier this month, President Obama selected Dr. Margaret Hamburg, a biodefense expert and former New York City health commissioner, to serve as FDA commissioner, and Baltimore health commissioner Dr. Joshua Sharfstein as principal deputy commissioner.  The president also announced plans for a Cabinet-level group to advise on food safety improvement, reported Reuters.

Today, food safety is split between the FDA and the U.S. Department of Agriculture (USDA), with the U.S. Centers for Disease Control and Prevention (CDC) in charge of disease outbreaks, said Reuters.  Many have criticized the FDA-USDA split, blaming overlaps and gaps between the two agencies for many of the food borne illness outbreaks that have made headlines for their massive toll on human health and commerce.  Take, for example, the most recent salmonella outbreak—linked to the Peanut Corporation of America (PCA)—that has sickened over 700 in nearly every state and Canada, has been linked to nine deaths, and has resulted in the largest recall food recall in U.S. history.

Trust for America’s Health and the Robert Wood Johnson Foundation issued a joint report asking the Obama administration to appoint a senior FDA official to handle food safety, said Reuters.  The two groups believe that, ultimately, a new agency, only responsible for food supply regulation, should be formed in the Department of Health and Human Services (HHS), added Reuters.  "Our food safety system is plagued with problems and is leading to millions of Americans becoming severely sick each year," said Jeff Levi, Trust for America's Health’s executive director, quoted Reuters, citing a media conference call.

Reuters also quoted Michael Taylor of George Washington University as saying that, "The FDA has jurisdiction over 80 percent of the food supply, including virtually all imports.  Recent nationwide outbreaks involving salmonella-tainted produce and peanuts expose really critical shortcomings at FDA and CDC with respect to both prevention and response to food borne outbreaks."  Taylor was an advisor for the report and has worked in food safety for both the FDA and USDA, Reuters explained.

Saying that, "I believe the first priority should be to repair what is wrong at FDA," Taylor noted that the agency suffers from three serious issues:  “Obsolete statutes that focus on reacting to problems instead of preventing them, inadequate resources that have resulted in ‘serious gaps in standard-setting and a weak enforcement program,’ and a fragmented structure that impedes management,” said Reuters, citing Taylor

Taylor noted what many critics have long been saying, that the FDA is more concerned with the drug side of the agency, pointing out that, "There is no FDA official whose full-time job is food safety," reported Reuters.  This has led to, said Michelle Larkin of the Robert Wood Johnson Foundation, about one in four Americans, becoming ill from a food borne pathogen yearly, said Reuters, adding that this translates into 76 million people, with over 300,000 hospitalizations and 500,000 deaths.  “It costs us around $44 billion annually in medical care and lost productivity, so the stakes are really high," Larkin added, quoted Reuters.