the FDA’s Own Self-Assessment; We Have Failed to Protect the American People

This article is a direct quote from the FDA’s own website


FDA Mission Statement

“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.”

In November, 2007, the FDA came to these SHOCKING CONCLUSIONS ABOUT THEMSELVES

The Subcommittee concluded that science at the FDA is in a precarious position: the Agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.

The Subcommittee found that the deficiency has two sources:

The demands on the FDA have soared due to the extraordinary advance of scientific discoveries, the complexity of the new products and claims submitted to FDA for pre-market review and approval, the emergence of challenging safety problems, and the globalization of the industries that FDA regulates.

The resources have not increased in proportion to the demands

The result is that the scientific demands on the Agency far exceed its capacity to respond. This imbalance is imposing a significant risk to the integrity of the food, drug, cosmetic and device regulatory system, and hence the safety of the public.

The Subcommittee further noted that

The impact of the deficiency is profound precisely because science is at the heart of everything FDA does.

  1. The Agency will flounder and ultimately fail without a strong scientific foundation. That foundation rests on three pillars.
  2. The first pillar is strong selective scientific research programs that are appropriately mission-supportive, in all areas of FDA responsibility.
  3. This research is critical because it is not conducted by other public or private entities, but is fundamental to the discharge of FDA’s statutory responsibilities to protect and promote the public health. The second pillar is excellent staff with cutting-edge scientific expertise appropriate to the mission.

So, what did the FDA conclude relative to their responsibility to the American people?

Major Findings
The Subcommittee found substantial weaknesses across the Agency, with the possible exception of some drug and medical device review functions funded by industry user fees. There are several areas of greatest concern, however, which form the basis for this report’s most significant findings.

 The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak.

The nation’s food supply is at risk

Crisis management in FDA’s two food safety centers, Center for Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine (CVM), has drawn attention and resources away from FDA’s ability to develop the science base and infrastructure needed to efficiently support innovation in the food industry, provide effective routine surveillance, and conduct emergency outbreak investigation activities to protect the food supply.

FDA’s inability to keep up with scientific advances means that American lives are at risk. While the world of drug discovery and development has undergone revolutionary change — shifting from cellular to molecular and gene-based approaches — FDA’s evaluation methods have remained largely unchanged over the last half century. Likewise, evaluation methods have not kept pace with major advances in medical devices and use of products in combination.

The world looks to FDA as a leader — to integrate emerging understandings of biology with medicine, technology and computational mathematics in ways that will lead to successful disease therapies. Today, not only can the Agency not lead, it cannot even keep up with the advances in science.

In the FDA’s own words

  1. The FDA cannot adequately monitor development of food and medical products because it is unable to keep up with scientific advances.

  2. The FDA cannot fulfill its surveillance mission because of inadequate staff and IT resources to implement cutting-edge approaches to modeling, risk assessment and data analysis

  3. The FDA lacks a coherent scientific structure and vision as a result of weak organizational infrastructure

  4. Consistent and rigorous peer reviews of programs and processes, which are currently lacking, are critical for wise utilization of resources and for rebuilding the Agency’s ability to implement its science-based regulatory responsibilities effectively.

  5. The turnover rate in FDA science staff in key scientific areas is twice that of other government agencies

  6. There are insufficient programs of measurement to determine worker performance

  7. There is insufficient investment in professional development, which means that the workforce does not keep up with scientific advances

  8. the FDA does not have sufficiently extensive collaboration with external scientists, thus limiting infusion of new knowledge and missing opportunities to leverage resources

“The FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability.”

“FDA’s failure to retain and motivate its workforce puts FDA’s mission at risk. Inadequately trained scientists are generally risk-averse, and tend to give no decision, a slow decision or, even worse, the wrong decision on regulatory approval or disapproval. During our encounters with staff and center leadership, we were struck by the near unanimity that the shortage of science staff (due to lack of resources to hire) and the inability to recruit and retain needed expertise are serious, longstanding challenges. Internal expertise and experience to provide the science capability and capacity needed in highly specialized and fast-evolving areas is disturbingly limited. The lack of a trained workforce means that the FDA is ineffective in responding to emerging fields that require individuals and work teams with multidisciplinary skills built on very complex, highly specialized, often esoteric bodies of knowledge.”

This is the first in a series of articles exposing the FDA’s own self-assessment on how they are doing against the charter imposed by our US Congress to protect us. The FDA’s conclusions will totally shock you!  Stay tuned……




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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