Should you trust the FDA? New report raises serious concerns

December 4, 2007

Lives are at risk because the U.S. Food and Drug Administration is woefully behind in the latest scientific advances and is underfunded for its vast responsibilities. In a 56-page report titled “FDA Science and Mission at Risk,” officials will hear that inadequate staffing and poor retention, out-of-date technology and a general lack of resources mar the agency’s ability to do its job.

The FDA regulates products ranging from pharmaceuticals and medical devices to food and cosmetics, representing about $1 trillion, or a quarter of every dollar spent in the U.S.

Their mission statement reads:

“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.”

The FDA’s chief commissioned the year long report to assess whether its scientific expertise can support its regulatory mission.

“FDA’s inability to keep up with scientific advances means that American lives are at risk,” said the report, written by a subcommittee to the Science Board, an expert advisory group.

The report uncovered failures at every turn. One of the most glaring is that the FDA lost 600 inspectors in the past four years, making the agency unable to protect the country’s food supply. And the FDA’s responsibilities have grown, rendering the agency ineffecitve. Bill Hubbard, a former FDA associate commissioner, said, “When I came to the FDA in the early 1970s, we were doing 35,000 food inspections a year. This year, the agency will be doing 6,000.”

Food-related highlights from the report:

• The Subcommittee found that FDA’s ability to provide its basic food system inspection, enforcement and rulemaking functions is severely eroded, as is its ability to respond to outbreaks in a timely manner and to develop and keep pace with the new regulatory science needed to prevent future problems arising from both novel (prion disease, genetically modified organism) and traditional (resistant microbes, chemical contamination) sources.
• There is an appallingly low inspection rate: the FDA cannot sufficiently monitor either the tremendous volume of products manufactured domestically or the exponential growth of imported products. During the past 35 years, the decrease in FDA funding for inspection of our food supply has forced FDA to impose a 78 percent reduction in food inspections, at a time when the food industry has been rapidly expanding and food importation has exponentially increased. FDA estimates that, at most, it inspects food manufacturers once every 10 years, and cosmetic manufacturers even less frequently.
• The Agency conducts no inspections of retail food establishments or of food-producing farms.
• The Subcommittee’s findings are consistent with those of previous committees that voiced deep concerns about the viability of the foods program and the lack of Agency priority for food issues. Sixteen years ago the Final Report of the Advisory Committee on the Food and Drug Administration to the Secretary of Health and Human Services (HHS) (May 1991) identified the same problems : “There are deep concerns about the viability of the foods program and the lack of Agency priority for food issues.
• Decline in resources and program initiatives during the past 10–15 years indicate a lack of Agency management attention and interest in this area, although public interest in, and concern for, an effective food program remain high.” Since 1991, continued declines in resources and personnel have exacerbated this situation.
• CVM has the authority of ensuring the safety of milk, meat and eggs. However, the Center is faced with myriad other regulatory demands; including assessing safety of genetically modified foods and engineered animals used to make biotechnology-based drugs for humans (so-called biopharming); developing analytical techniques to screen meat, milk and eggs for volatile residues of drugs, pesticides and environmental contaminants; as well as managing the approval of an explosion of new pet-animal drugs that are essentially a microcosm of the human drugs regulated by both CDER and CBER (partially supported by Animal Drug Use Fee Act). When Bovine Spongiform Encephalopathy (BSE), commonly known as mad cow disease, first appeared in Europe and elsewhere, consumers and the industry looked to the FDA to ensure that the disease would not spread to the US through the animal feed that FDA regulates. But Agency officials were denied the funds to bring the feed industry into rapid compliance with the new feed regulations, and the disease did indeed appear in the US. Perhaps if the small sums requested by FDA had been provided, Japan and other countries would not have cut off imports of US beef and American producers would not have suffered multibillion dollar losses. To this day, the BSE research program, as well as others in the CVM related to detection of newly emerging infectious agents, remains seriously underfunded.
• The recent pet food safety crisis has strained this overtaxed system. CVM received more than 18,000 telephone calls concerning melamine pet food contamination. The pet food industry is a $15 to $20 billion a year business and largely falls within FDA’s regulatory purview. It was estimated that about 1 percent of the total volume of pet food was involved with a potential economic impact of $200 million. CVM is able to devote only two people working full time on pet food issues.
• The dietary supplement industry has grown to more than $20 billion in annual sales, and millions of Americans use those products every day. But the legislation authorizing FDA regulation of those products has never been funded, the practical effect being that the products and their health claims go essentially unregulated. The same can be said of the cosmetics industry, which has more than $60 billion in annual sales, but is overseen by an FDA staff of 14 supported by $3.5 million budget. This industry is rapidly integrating nanotechnology for product delivery and yet, very limited expertise in this newly emerging area of science exists in the entire FDA.

For full report go to:

http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_01_FDA%20Report%20on%20Science%20and%20Technology.pdf

 

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