The FDA comes under fire as reports of mismanagement come to light.

Last December, Dr. Gail Cassell of Eli Lilly met with the media to provide a preliminary update on a soon-to-be-issued report entitled FDA Science and Mission at Risk.  The report was the result of a year’s worth of work by an expert panel appointed to evaluate the agency’s ability to meet present and future needs. Among the findings:

  • Inadequate inspection of manufacturers, especially food manufacturers, which must be inspected only once every 10 years

  • A broken food import system that grows riskier every year

  • A depleted staff

  • A workforce whose scientists are not fully informed of current technologies, and

  • An obsolete information technology system.

    The report implied that, without additional financial support for increasing staff and  resources, public health could be in jeopardy.

    Various FDA programs have been developed for different sectors based on risk, experience and regulatory pressures including: 

    1. Inadequate Inspection of Food Manufacturers. This is not the concern so many think. Regulatory inspection does not guarantee food quality or safety. The US meat and poultry industry is under continuous inspection, yet it continues to have recalls. Topps Beef mounted a 21 million-pound recall, yet it was under continuous inspection when the problems occurred.

    Could inspectors in the fresh-cut operations have prevented the E. coli 0157:H7 outbreaks last autumn? Definitely not. The real question is “Have the industry and regulators learned from this incident?” I think they have, and that learning will be applied to minimize future outbreaks.

    What many people, including consumer advocates, do not understand is that food safety and quality equal good business. Also, most food processors are subject to at least one, and often as many as 20, stringent audits by clients or audit firms working on behalf of clients.

    Finally, there are some food processing operations that simply do not warrant regular inspections. These products are safe, based on risk assessments.

    2. Broken Import System. We have seen melamine in ingredients, malachite green in seafood and illegal antibiotics in honey. Does this mean the system is broken? Maybe yes, maybe no. The melamine issue would be a no.

    Product evaluations are based on past experiences and problems. If there has never been a concern with a chemical or a pathogen, it will not be included in a testing protocol. And, there has to be a level of contamination that is detectable using normal sampling protocols. HACCP was initially developed because traditional sampling procedures were inadequate in ensuring safety. The solution lies in building safety into the process, not testing procedures.

    3. Depleted Staff. The FDA needs more people at all levels, especially scientists who not only understand analytical methods, but can also develop better screening tools for field personnel. The industry has grown, but the FDA has not grown with it.

    4. Lack of Expertise. People who truly understand the industry are essential.

    5. Obsolete Information Technologies. One issue cited in the report was that there are vast numbers of records (clinical trial data, process filings, etc.) filed but apparently not accessible in storerooms. As to whether its computers are obsolete or employees are forced to hand write reports is something I cannot validate.

    Another problem is that the FDA data systems do not communicate seamlessly with other agencies (e.g., Customs, USDA, etc.).

    I don’t think the FDA is broken, but more funding, staffing and improvements are needed. Any business, agency or firm can never accept the status quo. All operations must strive for continuous improvement.