American’s at Risk; FDA Fails to Protect Us From BAD Food and Drugs

This is the forth and final article on how the FDA has failed to meet its charter established by the US Congress.

Everything in this article is directly from the FDA’s own report dated 2007.


Massive Failure admitted by the FDA

“In contrast to previous reports that have issued many of the same warnings, there are now sufficient data proving that failure to act in the past 

has jeopardized the public’s health. We, therefore, urge the FDA to develop a comprehensive plan that includes how and when the Agency will respond to these recommendations, and to report that plan to the Science Board.”

“The Subcommittee found that the FDA lacks sufficient expertise in quantitative methods, such as statistics and biomathematics, to effectively assess products and guide sponsors to design valid and informative studies.”

The Subcommittee found that the FDA also has a lack of expertise in risk/benefit assessment. Such assessments have traditionally been made informally.


Recommendations of excellent FDA reviews are seldom followed

“Our final recommendation is based in our belief that effective resolution of the issues outlined in this report is urgent. In contrast to previous reports that have issued many of the same warnings, there are now sufficient data proving that failure to act in the past has jeopardized the public’s health.”


Food Safety

“In his recent Executive Order announcing an Inter-Agency Working Group on Import Safety, President Bush stated that the current system must be fixed “within available resources.” We can state unequivocally that the system cannot be fixed “within available resources.” For example, the Coalition for a Stronger FDA estimates that an excess of $130 million is needed to devise and implement a new food import system.”


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

“The development of medical products based on “new science” cannot be adequately regulated by the FDA. Many Critical Path projects and pilots that have been initiated are currently at risk.”


FDA “Drugs at Risk”

The mission of getting safe and effective drugs to patients in a timely manner is currently threatened by inadequate expertise and capabilities.


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.


Conclusions

So, it appears that the sterling reputation enjoyed by the FDA GLOBALLY has a severe tarnish.  Let us hope and pray that they get their act together so that we, the American People can rest assured that the foods we eat and the drugs we consume are safe and effective.

Currently, the FDA seems to be chasing activities that do not support their mission.  The FDA is in trouble and unless we can re-focus them on real health issues and stop seeing Pharma as their real customer, will the American People finally be assured that we are safe and that the FDA is really doing its job.

We invite your comments and discussions.

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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.

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.

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 protect USA citizens while protecting the special interests of Pharaceutical companies.

FDA Blasts Itself For Failing To Protect the American People

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 readers 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.

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……

 

 

FDA’s Crackdown on Nutritional Suppliments Thwarted by Voter Outrage

The FDA’s NDI (new supplement) guidance threatens our access to supplements and indeed could destroy the industry, leaving drugs with a total monopoly.

After adamantly digging in its heals and refusing to reconsider, FDA has now at last agreed that the draft NDI guidance requires substantial revision. This follows a meeting between FDA Commissioner Margaret Hamburg and Mike Taylor, Deputy Commissioner of Foods, with Senators Harkin and Hatch, longtime champions of natural health.

According to our sources, the FDA stated in the meeting that the guidance would be revised to account for the numerous comments and concerns, and released in draft form once again, which will then be open for public comment. This is exactly what we asked for!

The FDA’s decision is a dramatic reversal of the position taken in an earlier meeting with the Senators’ representatives, in which they adamantly refused this very same request. While we may never know how or why the FDA changed their position, it is very likely that they were responding to our sustained public messages opposing the current NDI draft guidance.

ANH-USA has also been working closely with the Appropriations Committee that controls the FDA’s purse strings. We recently helped secure report language in the Appropriations Committee censuring the FDA for prematurely enforcing the NDI draft guidance while supposedly still in draft. The report goes on to further state: “The Committee urges FDA to withdraw the July 2011 NDI draft guidance and re-engage the dietary supplement community to develop a new guidance on what constitutes NDI.” This appears to be another reason the FDA is finally listening.

While the FDA has not yet agreed to a specific timeline for revising the guidance, nor indicated what exactly will be revised, they did commit to collaborating with the dietary supplement industry to create a list of agreed-upon “grandfathered” dietary ingredients (ie. supplements). A “grandfathered” dietary ingredient is an ingredient marketed before 1994 and therefore not considered an NDI (new). Grandfathered dietary ingredients are therefore not subject to the NDI guidance. Currently, there is no authoritative list of “grandfathered” dietary ingredients, leaving the legal status of many dietary supplements in limbo.

Although an authoritative list of “grandfathered” dietary ingredients could be useful to the supplement industry, we fear that the FDA will use this as an opportunity to knock out supplements that were indeed on the market before 1994 but may not meet the FDA’s idea of proof. This is precisely what happened to pyridoxamine, one of only three natural and bioavailable forms of vitamin B6. Although we know that pyridoxamine was on the market before 1994, the FDA determined that there was not enough of the right kind of evidence to conclusively prove so, and removed the ingredient from the market.

ANH-USA will participate in this process to try to ensure that the list of “grandfathered” dietary ingredients is inclusive in order to maintain your access to as many supplements as possible. We will also try to prevent the FDA from using the list as an excuse to delay indefinitely their promise to revise the draft guidance.

Your Health Freedoms Are at Risk

Write to your Senator or Congressman and let them know that you want to enjoy the freedom to choose when it comes to making informed health decisions.  Protect your health freedoms by screaming at the top of your lungs until the government finally understands that we are determined to maintain our health freedoms. www.nutrasilver.com

MRSA Superbug Lawsuit: Court Orders FDA to Do Its Job

MRSA is found on your dinner table

80% of all antibiotics use in the USA is for animals

This week a judge told FDA to reverse course regarding antibiotic overuse in livestock and protect the effectiveness of the medicine for humans.

For the past 35 years the FDA has supposedly been reviewing the routine use of antibiotics in animal feed when in fact the agency was simply sitting on its hands. Then, last December, the agency caved to pressure and quietly withdrew any attempt to require the removal of antibiotics from animal feed.

Back in 1977, FDA concluded that feeding animals low doses of certain antibiotics used in human medicine, namely, penicillin and tetracyclines, could promote antibiotic-resistant bacteria capable of infecting people. Despite this conclusion—and in direct violation of laws requiring that the agency move on its findings—FDA failed to take action for the next 35 years.

The so-called “preventive” use of antibiotics in livestock is routine and widespread—80% of all antibiotics sold in US go into farm animal feed. Factory farms use them to ward off illness in animals that are kept in overcrowded, filthy living conditions, which are a perfect environment for the spread of illness. These antibiotics are also used to promote increased growth in animals.

MRSA "superbug" in your food!

How much of your beef is contaminated with MRSA?

However, antibiotics given to animals are transferred to humans through direct contact, environmental exposure, and the consumption and handling of contaminated meat and poultry products—making humans vulnerable to antibiotic-resistant superbugs, which are now a global problem. Moreover, a study found that up to half of US meat was contaminated with antibiotic-resistant staph.

Federal Court rules against the FDA

US Federal Court, New York

Now, as a result of the lawsuit, FDA is forced to take action on its own safety findings by withdrawing approval for most non-therapeutic uses of penicillin and tetracyclines in animal feed, unless the industry can prove in public hearings that those drug uses do not affect human health. The judge also ruled that FDA must warn drug makers that the government may soon ban the agricultural use of antibiotics for animals that are not sick.

Court instructions to the FDA

“For the foregoing reasons, Plaintiffs’ Motion for Summary Judgment on their first claim for relief is granted and Defendants’ Motion for Summary Judgment is denied. Defendants are hereby ordered to initiate withdrawal proceedings for the relevant NADAs / ANADAs (approvals to use antibiotics).

Specifically, the Commissioner of the FDA or the Director of the CVM must re issue a notice of the proposed withdrawals (which may be updated) and provide an opportunity for a hearing to the relevant drug sponsors; if drug sponsors timely request hearings and raise a genuine and substantial issue of fact, the FDA must hold a public evidentiary hearing. If, at the hearing, the drug sponsors fail to show that use of the drugs is safe, the Commissioner must issue a withdrawal order.”

Who does the FDA protect, anyway?What exactly is the Court ordering the FDA to do?

Although the Court is ordering the FDA to complete mandatory withdrawal proceedings the relevant penicillin and tetracycline NADAs/ANADAs, the Court is not ordering a particular outcome as to the final issuance of a withdrawal order. If the drug sponsors demonstrate that the subtherapeutic use of penicillin and/or tetracyclines is safe, then the Commissioner cannot withdraw approval.

So Ordered.

THEODORE H. KATZ UNITED STATES MAGISTRATE

Dated: March 22, 2012

New York, New York

MRSA Now Accounts for More Deaths in the USA than HIV/ AIDS

The greatest challenge to medical science today is MRSA, the number one cause of infectious deaths in hospitals. Since the mid 1950’s MRSA has evolved to become nearly invincible to most antibiotics. Because of this, science is frantically seeking a replacement the will eliminate MRSA symptoms while avoiding the constant cycle of new antibiotic, MRSA mutates and is impervious to it so new antibiotics must be created.

What can you do to protect you and your family?

You can PREVENT MRSA infection by taking small amounts of colloidal silver.
 
“Colloidal silver has proven to be toxic to all tested species of fungi, bacteria, protozoa, parasites and many viruses. More importantly—unlike conventional antibiotics—infectious agents cannot build a resistance to silver. Taken internally, it may improve digestion; help prevent colds, flu and all organism-caused diseases. It can be used as a douche, atomized, nebulized or inhaled. Applied externally, it has been shown to help with things such as skin abrasions and burns (including sun burn). It can also be dropped into the eyes and ears to help the body overcome infection.”  — Kurt Grange, Ph.D., N.D., nutritional bio-physiologist and author
“My 4 year old daughter has MRSA. As an MD, I had access to virtually every MRSA/Staph treatment available to Western Medicine. Nothing worked. I applied NutraSilver, a natural mineral, on my daughter topically. She also took small amounts orally. Within 4 days I saw an impressive improvement. NutraSilver really came through for us!”— Mike, MD, 2010

 

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