The Food and Drug Administration may be the only federal agency that both political parties agree is in desperate need of an overhaul.
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President Barack Obama is promising action, though progress has been slow in the first 100 days. His choice to head the FDA — Dr. Margaret Hamburg — still has not been confirmed by congress.
Assuming Hamburg is confirmed, she will head an agency whose own Science Board concluded more than two years ago “is at risk of failing to carry out its mandate, leaving our citizens at risk of grievous harm.”
The FDA is responsible for overseeing the safety of the nation’s foods, drugs, medical devices and consumer products. In each of those areas, the agency is widely regarded as having fallen down on the job.
But its biggest black eye comes from the way the agency has handled its food safety responsibilities.
Safety of the food supply
The president has promised to act quickly to ensure the safety of the nation’s food supply, following the most recent salmonella outbreak involving peanut butter that has sickened nearly 500 people and killed 10.
That outbreak follows others involving baby formula, pet food, spinach, jalapenos, cooked ham, anchovies — and the list goes on.
After pointing out that America’s food safety laws have not been updated since they were written during Teddy Roosevelt’s administration, the president announced the creation of a new “Food Safety Working Group.” The group’s mission is to determine how our food safety laws need to be overhauled.
During an interview with NBC’s Matt Lauer on the Today Show, Obama said “at a bare minimum, we should be able to count on our government keeping our kids safe when they eat peanut butter."
"That’s what Sasha eats for lunch,” he added, referring to his daughter.
Among the FDA’s handicaps is enforcing food safety; it does not have the authority to order a recall on its own. It relies on the cooperation of food providers to voluntarily recall products.
Complicating efforts, the FDA is not alone in policing food safety. Even though the FDA is responsible for 75 percent of the food supply, the USDA actually gets 80 percent of the food safety funding, though its responsibilities are limited to meat and poultry.
Marion Nestle, the author of “Safe Food” and a professor of food studies and public health at New York University, writes in the San Francisco Chronicle “this weird division of responsibility began in 1906, and it’s breathtaking in its irrationality. The FDA oversees the safety of cheese pizza; the USDA oversees pepperoni pizza.”
Meanwhile, the FDA is so understaffed, it’s only able to inspect roughly 1 percent of foods that are imported into the country. And the rate of inspections at U.S. plants isn’t much better. The FDA had not inspected Peanut Corporation of America’s Georgia plant since 2001. Investigators say PCA’s own internal tests repeatedly found salmonella traces, but it continued to sell peanut butter products.
The Obama administration has already signaled that it intends to streamline the entire food safety process.
Agriculture Secretary Tom Vilsak told NBC News in February that “we need to figure out how to coordinate what FDA does and USDA does and ultimately merge those entities into a single food agency that would be responsible for all food products so that there’s no possibility of something falling through the cracks.”
Don’t be surprised if a central theme in the president’s Food Safety Working Group includes merging the responsibilities of the USDA and FDA into a single agency.
However, experts also suggest food safety will not improve unless cities and states also improve their food safety procedures.
A stronger FDA
Look for Obama to increase oversight of imports and closer inspection of domestic food production as well, though it’s unlikely a new food safety agency would have the manpower necessary to inspect every import and every U.S. plant involved in food or drug manufacturing.
The FDA’s own Science Board notes “there are 375,000 establishments making FDA-regulated products.”
“In just a decade, there has been a ten-fold increase in imports, coming from more than 100 other countries. Over 50 percent of drugs are imported, along with 15 percent of our food supply,” according to the report.
Former FDA Associate Commissioner William Hubbard told NBC News "I think the agency is at a tipping point. If change doesn't come in terms of new management and resources, they could be a failed institution."
While former President George W. Bush preferred a market-based approach to food and drug safety, Democrats in Congress are already moving toward giving the FDA more power.
The House passed a bill on April 2 that would give the FDA the power to change the ingredients in cigarettes and mandate new warning labels. However, the bill stops short of giving the FDA the authority to ban tobacco products or nicotine. A similar bill is under consideration in the Senate.
Tobacco is considered a leading cause of preventable deaths in America, killing more than 400,000 people each year. Yet until now, tobacco products have been among the least-regulated products in the nation. Even Obama has been trying to wean himself off the habit.
Assuming she is confirmed by the Senate, Hamburg will have her hands full when she takes over as FDA Commissioner.
Her track record suggests she’s up for the challenge. Her resume includes stints as the senior scientist for the Nuclear Threat Initiative where she also served as vice president of biological programs; assistant secretary for planning and evaluation at the Department of Health and Human Services; New York City health commissioner.
She's also held positions with the National Institute of Allergy and Infectious Diseases, and the Office of Disease Prevention and Health Promotion at HHS.
The White House's priorities, and her own, will likely be revealed during her confirmation hearings on Capitol Hill.
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