FDA Mission Failure; a Report From the FDA

This is the third in a series of expose’ quoted DIRECTLY FROM THE FDA’S OWN WEBSITE.

FDA Blasts itself for failing to fulfill its charter to protect Americans

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 products27. 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 (Appendix D, page 1): “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.

It is crucial that both food-based Centers develop the science needed to fulfill their mandated missions.

The strengthening of science in these Centers must be insulated from acute crisis management. This will involve a two-pronged approach. The first is to immediately correct the historical lack of support for staff and infrastructure needed to address current issues. Both Centers have accurately defined areas that need attention, and this Subcommittee agrees with this assessment. Directly supporting these initiatives is largely one of funding, as addressed in recommendation.

This second phase should be conducted in parallel with this Subcommittee’s recommendations for Agency-wide changes in science administration and support as embodied in a Chief Scientific Officer with budgetary authority, as well as modernization of IT infrastructure. The unending series of management by crisis in both CFSAN and CVM has seriously eroded the morale of existing dedicated staff and hampered recruitment of new scientists trained in areas of emerging biology, chemistry and bioinformatics. This situation, coupled with the early retirement of senior scientists and the recent departure of the director of CFSAN, puts the state of science in serious disarray. These issues should be a high priority on the agenda of the new Chief Scientific Officer.

Finding: The development of medical products based on “new science” cannot be adequately regulated by the FDA.

Rapid changes in biological sciences and bioinformatics are exceeding the capacity of current FDA science capabilities to keep pace and adequately support the Agency’s safety mission. The FDA lacks sufficient expertise to understand the impact of product use, to maintain ongoing currency with their evolution or to evaluate the sophisticated products produced. In addition, the FDA has no consistent strategy to acquire that expertise.

The lack of an adequate IT infrastructure creates further challenges.

Against the backdrop of an already inadequate information system across the Agency, as discussed in our additional findings below, there is minimal genomics IT infrastructure to support genomics-focused efforts. This is an especially important deficiency because genomics as well as proteomics, metabolomics, combination products (drug or biologic and a device) and other emerging sciences and technologies are creating larger amounts of data than current technologies in support of product design, testing, and production and for ongoing safety analysis.

“FDA Mission at Risk”

The lack of new science capability/capacity places the FDA mission at risk for those many products at the leading edge of innovation. This compromises not only the public health mission since the Agency cannot effectively regulate products built on emerging science, but it also hamstrings the Agency’s ability to support innovation in the industries and markets that it regulates.

Stay tuned for the fourth and final article revealing how our Government is failing to protecting USA citizens while protect the special interests of Pharaceutical companies.

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About CareMan
I am the CareMan, have been for 7 years now. I really do care about YOU and getting YOU back to great, natural health, so long as you have an open mind.

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