FDA Failure; Their Own Report!

The article is a second in a series that reveals what the FDA says about themselves in this shocking and disturbing report

With the exception of this paragraph, EVERYTHING IN THIS ARTICLE IS TAKEN DIRECTLY FROM FDA’S OWN REPORT ON THEMSELVES.

A strong Food and Drug Administration (FDA) is crucial for the health of our country. The benefits of a robust, progressive Agency are enormous; the risks of a debilitated, under-performing organization are incalculable.

The FDA constitutes a critical component of our nation’s healthcare delivery and public health system. The FDA, as much as any public or private sector institution in this country, touches the lives, health and wellbeing of all Americans and is integral to the nation’s economy and its security.

The importance of the FDA in the nation’s security is similarly profound. The FDA plays a central role in protecting the nation from the potential effects of terrorist attacks1, such as anthrax, smallpox, attacks on the food supply, nerve agent attacks and radioactive contamination, as well as from naturally occurring threats, such as SARS, West Nile virus and avian influenza.

FDA’s Own Findings

The number of appropriated personnel in 2007 was roughly the same number as was appropriated 15 years earlier. This reality, combined with a burgeoning industry has has made it increasingly impossible for FDA to maintain its historic public health mission.

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

FDA does not have the capacity to ensure the safety of food for the nation

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.t

The following list is long and arduous, but the reader will benefit if time is taken to fully understand the dire condition of our FDA.

FDA’s Admitted Deficiencies

  1. 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.
  2. 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.
  3. 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.
  4. 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. In addition, the FDA has no consistent strategy to acquire that expertise.
  5. Even though there is a great deal of enthusiasm, many Critical Path projects and pilots that have been initiated are currently at risk. None is adequately resourced. Although some remarkable successes have been emulated internationally, most have stagnated.
  6. The lack of an adequate IT infrastructure creates further challenges. Against the backdrop of an already inadequate information system across the Agency,
  7. 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.
  8. The FDA also has a lack of expertise in risk/benefit assessment. The Subcommittee notes that another important area for quantitative methods development is risk-benefit assessment. Such assessments have traditionally been made informally, but as the public’s concern about the value and safety of new drugs continue to grow and as the complexity and volume of data informative about potential benefits and risks increases, more formal methods will be important for optimal decision making.Finding: The FDA science agenda lacks a constructure and vision, as well as effective coordination.
  9. The FDA has substantial recruitment and retention challenges.
  10. The FDA has inadequate funding for professional development.
  11. All of the working group subcommittees discovered significant deficiencies in the ability of regulatory programs to access
  12. The FDA lacks the information science capability and information infrastructure to fulfill its regulatory mandate. the FDA information technology resources, workforce and infrastructure prevent it from delivering critical innovation in IT that is required to support its current and expanding regulatory mandate.
  13. the FDA lacks the information sciences and infrastructure to support new science.
  14. The FDA IT infrastructure is obsolete, unstable, and lacks sufficient controls to ensure continuity of operations or to provide effective disaster recovery services.
  15. FDA data and information infrastructure is at risk due to an evolving but incomplete migration to a robust enterprise model. As many as 80 percent of the network servers are more than five years old and have exceeded their recommended service life.
  16. FDA does not follow IT best practices. It has not currently implemented and/or appropriately staffed to provide effective governance, capital planning/investment control and enterprise architecture activities. The consequences of this are manifested in the deficiencies noted above: an unreliable technology infrastructure, inability to support science and inability to obtain required data in a timely manner to conduct its regulatory mission at acceptable levels.the FDA does not follow IT best practices. It has not currently implemented and/or appropriately staffed to provide effective governance, capital planning/investment control and enterprise architecture activities. The consequences of this are manifested in the deficiencies noted above: an unreliable technology infrastructure, inability to support science and inability to obtain required data in a timely manner to conduct its regulatory mission at acceptable levels.
  17. The IT workforce is insufficient and suboptimally organized.
  18. the workforce deficiency is present at all levels of the IT organization.
  19. The FDA has experienced decreasing resources in the face of increasing responsibilities.

In sum, the current resources have clearly been insufficient to support the regulatory science and regulatory services of the FDA.

We welcome comments from our reader so that we can exchange information regarding our beloved FDA. The third and final FDA self-exposure report will follow soon; you will be amazed at what the FDA concludes about itself and its future ability to serve the American people.

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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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