Toothpaste, dog food or children’s toys: Which one of these tainted products could have been prevented from coming to market?
The fact is that all of them could have been stopped – well before any consumers were harmed. How? Manufacturers and retailers could have shared “secrets” about supplier quality, preventing bad actors from getting their wares onto store shelves.
That’s a big change from the way most companies operate today. But businesses need to change their ideas about what matters – and bring ‘transparency’ into the supply chain that tracks the product at each stage of production.
The reality is that in most industries – aerospace and defense, consumer goods, automotive, industrial equipment and more – the manufacturers and retailers use the same suppliers as their competitors. This model makes it the perfect time to create global standards for information about suppliers and the subcontractors producing products, which sometimes, to be honest, aren’t very good, or very clean.
For the first time, uniform, broadly provided data can be used by all manufacturers and retailers to create standards to which suppliers must adhere. This is especially important for the four-steps-removed mom-and-pop shops that are often creating key components for name-brand products, with “controls” that are undocumented, and often, ignored.
Case Study: Avoiding supply chain disasters
Let’s take the recent Topps Meat Company recall as an example. As reported in The New York Times, more than 21.7 million pounds of potentially contaminated beef products were recalled allegedly due to a breakdown in one of Topps’ Canadian suppliers. Contaminations were reported from all over the country and many end-consumers became extremely ill from consuming the beef. As a result, Topps, a producer and distributor of beef products, was forced to permanently close its doors and file for bankruptcy.
Unfortunately, the Topps Meat Company example is not one of a kind. Every few months, there is a massive product recall due to contamination, whether it is from E. coli, lead paint in toys or defective automobile parts. The fact that most companies are unaware of where these contaminations take place is a huge red flag yet a frightening and common reality.
Is it really fair to put all the blame for the sale of the contaminated beef on a company like Topps Meat Company? The answer is yes and no. Creating safe products should be top-of-mind for all companies across the supply chain, not just the one that slaps its label on it at the end. All points of the supply chain need to be re-examined, and information on supplier quality and performance is a critical way to mitigate the ways in which companies take short-cuts to get products to market faster and cheaper.
Let’s pretend that we live in a perfect world where all supplier information is available to anyone who might do business with them. Not only would Topps Meat Company be able to track its direct suppliers but all of the tier two and three suppliers that also provide goods for the final product. If one of these suppliers had been flagged in the past for causing a contamination, and if the information was widely available, the whole disaster could have potentially been averted.
By Jim Lawton
November 18, 2009
Source: CNNMoney.com - Brainstorm Tech blog
Friday, November 20, 2009
Monday, October 19, 2009
Genetics & Food: Evolution 2.0
Humans have altered nature for thousands of years. Farmers have trimmed weeds into ever more productive grains and bred bigger, tastier animals. Is genetic engineering only the next evolutionary step or a step too far?
It really depends on how you ask the question: Would you like tastier tomatoes, healthier ham, and vegetables full of vitamins? Who wouldn’t raise a hand?
Now let’s rephrase it: Would you rather buy conventional food or genetically modified products? That’s usually when the enthusiasm fades.
Insulin, the only known treatment for diabetes, has been produced by genetically modified bacteria for 20 years. Before the advent of genetic engineering, patients had to use insulin from the pancreas of dead pigs and cows, which occasionally led to allergic reactions.
Insulin has become the GM success story, but it wasn’t an easy ride, recalls Johannes Klose, Scientific Advisor at Allianz Global Corporate & Specialty. “It took [the life-sciences company] Hoechst nearly 10 years to get their first insulin facility running. Nowadays, nobody would be scared. Millions of people use genetically engineered insulin.”
While a conservative and skeptical Europe remains a virtually GMO-free region, America has long accepted GM crops. Some 70 percent of the world’s soybean production and one quarter of all corn is genetically modified, and almost exclusively grown in the United States, Brazil, and Argentina. The Center for Food Safety estimates that up to 85 percent of U.S. corn is genetically engineered as are 91 percent of soybeans.
Its not that Americans don’t care, says Klose, they just don’t know. Whereas the European Union labels all products containing more than 0.9 percent of GM food stuff, no such labels exist in the United States. Once a new GM product has passed controls at the Food and Drug Administration, it is deemed safe to eat and enters the market unrecognizable.
According to the American Institute of Biological Sciences there are “no peer-reviewed publications of clinical studies on the human health effects of GM food.” It is nearly impossible to test the long-term effects on human health and the environment. “You would have to monitor this for decades, but you cannot do this because this would put people at risk,“ says Klose.
By Thilo Kunzemann
October 16, 2009
Source: Allianz
It really depends on how you ask the question: Would you like tastier tomatoes, healthier ham, and vegetables full of vitamins? Who wouldn’t raise a hand?
Now let’s rephrase it: Would you rather buy conventional food or genetically modified products? That’s usually when the enthusiasm fades.
Insulin, the only known treatment for diabetes, has been produced by genetically modified bacteria for 20 years. Before the advent of genetic engineering, patients had to use insulin from the pancreas of dead pigs and cows, which occasionally led to allergic reactions.
Insulin has become the GM success story, but it wasn’t an easy ride, recalls Johannes Klose, Scientific Advisor at Allianz Global Corporate & Specialty. “It took [the life-sciences company] Hoechst nearly 10 years to get their first insulin facility running. Nowadays, nobody would be scared. Millions of people use genetically engineered insulin.”
While a conservative and skeptical Europe remains a virtually GMO-free region, America has long accepted GM crops. Some 70 percent of the world’s soybean production and one quarter of all corn is genetically modified, and almost exclusively grown in the United States, Brazil, and Argentina. The Center for Food Safety estimates that up to 85 percent of U.S. corn is genetically engineered as are 91 percent of soybeans.
Its not that Americans don’t care, says Klose, they just don’t know. Whereas the European Union labels all products containing more than 0.9 percent of GM food stuff, no such labels exist in the United States. Once a new GM product has passed controls at the Food and Drug Administration, it is deemed safe to eat and enters the market unrecognizable.
According to the American Institute of Biological Sciences there are “no peer-reviewed publications of clinical studies on the human health effects of GM food.” It is nearly impossible to test the long-term effects on human health and the environment. “You would have to monitor this for decades, but you cannot do this because this would put people at risk,“ says Klose.
By Thilo Kunzemann
October 16, 2009
Source: Allianz
Thursday, October 15, 2009
Gillibrand Unveils Comprehensive Food Safety Improvement Plan
Contaminated Food Kills 5,700 Americans Each Year – Nation’s Food Safety Laws Have Not Been Overhauled In A Century
U.S. Senator Kirsten Gillibrand, the first New York senator to sit on the Senate Agriculture Committee in nearly 40 years, announced a comprehensive plan to overhaul the nation's food safety laws by improving inspection, recall response, and public education. A cornerstone of Senator Gillibrand's plan is new legislation to mandate E. coli inspections of ground beef.
According to the Centers for Disease Control and Prevention (CDC), every year an estimated 87 million Americans are sickened by contaminated food, 371,000 are hospitalized with food-borne illness, and 5,700 die from food-related disease. While the U.S. Department of Agriculture (USDA) has made some progress improving food safety regulations, the nation's food safety laws have not been significantly overhauled in more than a century, according to the Congressional Research Service.
"In America, in 2009, it is unconscionable that food is still going straight to our kitchens, school cafeterias and restaurants without being properly tested to ensure its safety," Senator Gillibrand said. "It's spreading too many diseases and costing too many lives. We need to do a better job of catching contaminated food before it ever comes close to a kitchen table. My plan addresses the gaps in the inspection process and improves recalls and public education, so parents have access to the information to keep their families safe."
Across New York State, approximately 5 million people are afflicted with a food-borne illness each year.
READ Senator Gillibrand's new report on food safety.
Report at: http://gillibrand.senate.gov/imo/media/doc/Food%20Safety%20Report.pdf
October 14, 2009
U.S. Senator Kirsten Gillibrand, the first New York senator to sit on the Senate Agriculture Committee in nearly 40 years, announced a comprehensive plan to overhaul the nation's food safety laws by improving inspection, recall response, and public education. A cornerstone of Senator Gillibrand's plan is new legislation to mandate E. coli inspections of ground beef.
According to the Centers for Disease Control and Prevention (CDC), every year an estimated 87 million Americans are sickened by contaminated food, 371,000 are hospitalized with food-borne illness, and 5,700 die from food-related disease. While the U.S. Department of Agriculture (USDA) has made some progress improving food safety regulations, the nation's food safety laws have not been significantly overhauled in more than a century, according to the Congressional Research Service.
"In America, in 2009, it is unconscionable that food is still going straight to our kitchens, school cafeterias and restaurants without being properly tested to ensure its safety," Senator Gillibrand said. "It's spreading too many diseases and costing too many lives. We need to do a better job of catching contaminated food before it ever comes close to a kitchen table. My plan addresses the gaps in the inspection process and improves recalls and public education, so parents have access to the information to keep their families safe."
Across New York State, approximately 5 million people are afflicted with a food-borne illness each year.
READ Senator Gillibrand's new report on food safety.
Report at: http://gillibrand.senate.gov/imo/media/doc/Food%20Safety%20Report.pdf
- In New York City, an estimate of nearly 2.1 million are afflicted with a food-borne illness each year;
- In Western New York, an estimate of nearly 360,000 are afflicted with a food-borne illness each year;
- In the Rochester-Finger Lakes Region, an estimate of over 310,000 are afflicted with a food-borne illness each year;
- In Central New York, an estimate of over 250,000 are afflicted with a food-borne illness each year;
- In the Southern Tier, an estimate of nearly 170,000 are afflicted with a food-borne illness each year;
- In the Capital Region, an estimate of over 280,000 are afflicted with a food-borne illness each year;
- In the North Country, an estimate of nearly 125,000 are afflicted with a food-borne illness each year;
- In the Hudson Valley, an estimate of an estimate of over 570,000 are afflicted with a food-borne illness each year;
- On Long Island, an estimate of over 715,000 are afflicted with a food-borne illness each year.
October 14, 2009
Tuesday, October 13, 2009
Make Our Food Safe
Every year, millions of Americans are sickened from consuming contaminated food, hundreds of thousands are hospitalized, and thousands of these people die.
Continued outbreaks of foodborne illness over the last several years – from spinach to peppers to peanut products – have demonstrated that these outbreaks are not random, unpreventable occurrences, but are due to widespread problems with our food safety system.
Our current food safety system is broken and has been in need of reform for decades. And this year, Congress has the opportunity to change course and help protect children, families, senior citizens and all others from foodborne illness.
Source: MakeOurFoodSafe.org
Continued outbreaks of foodborne illness over the last several years – from spinach to peppers to peanut products – have demonstrated that these outbreaks are not random, unpreventable occurrences, but are due to widespread problems with our food safety system.
Our current food safety system is broken and has been in need of reform for decades. And this year, Congress has the opportunity to change course and help protect children, families, senior citizens and all others from foodborne illness.
Source: MakeOurFoodSafe.org
Friday, October 2, 2009
FDA's Growing Role Regulating Health 2.0, Health IT
Many involved in the world of health IT know that federal regulation is part of the deal. Issues of health information privacy have been subject to an array of federal and state laws for decades. HIPAA, the Federal Privacy Act, laws governing Medicaid, Medicare, the Veterans Health Administration, funds used for the treatment of mental illness, sexually transmitted infections and on and on all have privacy provisions. There is a similar regulatory scheme for data security, again including HIPAA, the Gramm-Leach-Bliley Act and other laws.
More recently, Congress began authorizing HHS and its Office of the National Coordinator for Health IT to fund and regulate electronic prescribing standards, health IT standards, certification, "meaningful use", information exchange and other provisions found in the American Recovery and Reinvestment Act of 2009.
Regulation of Health 2.0?
What many do not know is that FDA likely will play an increasingly important role in regulating health IT. We're reminded of this most immediately by the recent announcement that FDA is holding a public meeting regarding the "Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools." The official announcement appears in the Sept. 21, 2009, Federal Register.
This hearing, set for mid-November 2009, in Washington D.C., is intended to help guide FDA in making policy decisions on how the Internet and social media tools (e.g., blogs, microblogs, podcasts, social networking sites, online communications, video sharing, widgets, and wikis) can be used to promote FDA-regulated medical products -- including human and animal drugs and biologics, and medical devices -- in a truthful, non-misleading, and balanced manner.
Specific questions that will be addressed at the meeting include:
October 2, 2009
Source: iHealthBeat
More recently, Congress began authorizing HHS and its Office of the National Coordinator for Health IT to fund and regulate electronic prescribing standards, health IT standards, certification, "meaningful use", information exchange and other provisions found in the American Recovery and Reinvestment Act of 2009.
Regulation of Health 2.0?
What many do not know is that FDA likely will play an increasingly important role in regulating health IT. We're reminded of this most immediately by the recent announcement that FDA is holding a public meeting regarding the "Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools." The official announcement appears in the Sept. 21, 2009, Federal Register.
This hearing, set for mid-November 2009, in Washington D.C., is intended to help guide FDA in making policy decisions on how the Internet and social media tools (e.g., blogs, microblogs, podcasts, social networking sites, online communications, video sharing, widgets, and wikis) can be used to promote FDA-regulated medical products -- including human and animal drugs and biologics, and medical devices -- in a truthful, non-misleading, and balanced manner.
Specific questions that will be addressed at the meeting include:
- For what online communications will manufacturers, packers or distributors be held accountable?
- How can manufacturers, packers and distributors fulfill regulatory requirements (e.g., fair balance) in their Internet and social network promotions?
- What parameters should apply to the posting of corrective information on Web sites controlled by third parties?
- When is the use of links appropriate?
October 2, 2009
Source: iHealthBeat
Tuesday, September 29, 2009
FDA made progress curing IT woes, panel finds
The Food and Drug Administration has made important progress in the last two years toward creating a more effective IT infrastructure, according to a preliminary report by the FDA Science Board’s Subcommittee on Information Technology.
The findings are notable because the panel lambasted the agency two years ago in a report that found that FDA’s computer systems could not support the agency’s main mission.
That earlier report, titled “FDA Science and Mission at Risk,” cited a range of problems, including decentralized and aging network servers, unreliable email systems, woefully inadequate disaster recovery programs and scientific computing capabilities that did not meet basic needs of the scientific staff.
But the most recent findings by committee strike a decidedly more positive tone. “The [agency’s] work greatly exceeded our expectations in terms of how much progress had been made putting together an IT infrastructure,” according to Dr. Sangtae Kim, head of the subcommittee which authored the report. “We saw a budget and a realistic plan to meet the challenges of a data-driven, science-driven agency.”
Kim said advances the FDA made in strengthening the IT infrastructure are largely due to its $2.5 billion, 10-year data center migration program. The Information and Computer Technology for the 21st Century (ICT21) program is a comprehensive, agency-wide IT modernization project that includes data management, data warehousing, IT infrastructure and IT security.
The final report is scheduled to be released in November.
By Elizabeth Laipson
September 25, 2009
Source: Government Health IT
The findings are notable because the panel lambasted the agency two years ago in a report that found that FDA’s computer systems could not support the agency’s main mission.
That earlier report, titled “FDA Science and Mission at Risk,” cited a range of problems, including decentralized and aging network servers, unreliable email systems, woefully inadequate disaster recovery programs and scientific computing capabilities that did not meet basic needs of the scientific staff.
But the most recent findings by committee strike a decidedly more positive tone. “The [agency’s] work greatly exceeded our expectations in terms of how much progress had been made putting together an IT infrastructure,” according to Dr. Sangtae Kim, head of the subcommittee which authored the report. “We saw a budget and a realistic plan to meet the challenges of a data-driven, science-driven agency.”
Kim said advances the FDA made in strengthening the IT infrastructure are largely due to its $2.5 billion, 10-year data center migration program. The Information and Computer Technology for the 21st Century (ICT21) program is a comprehensive, agency-wide IT modernization project that includes data management, data warehousing, IT infrastructure and IT security.
The final report is scheduled to be released in November.
By Elizabeth Laipson
September 25, 2009
Source: Government Health IT
Thursday, September 24, 2009
IOM to examine FDA's med device approval process
The Institute of Medicine will undertake a $1.3 million review of the Food and Drug Administration's approval process for certain new medical devices.
The study will examine the FDA notification process for new, low-risk medical devices that have the same use as existing devices and use similar technology or new technology that either does not raise any questions about safety and efficiency, or is at least as safe and effective as products already in the market. Among the medical devices to win approval under the review process this year: a liquid bandage, electronic blood pressure monitor and powder-free latex patient examination gloves.
The IOM, which was commissioned for the analysis, will consider how well the process protects patients and promotes innovation and what changes, if any, would improve results, according to an FDA press release. Meanwhile, the FDA Center for Devices and Radiological Health will undertake its own review "to evaluate and improve the consistency of FDA decision making", according to the release.
Janet Trunzo, executive vice president of technology and regulatory affairs for the Advanced Medial Technology Association, in a written statement, urged the IOM to include experts in medical device innovation and regulation. Trunzo praised the FDA's approval process as "well-defined, science-driven method" and said she believed the review would underscore strengths of the existing system.
The study's results are expected to be released in March 2011.
Melanie Evans / HITS staff writer
The study will examine the FDA notification process for new, low-risk medical devices that have the same use as existing devices and use similar technology or new technology that either does not raise any questions about safety and efficiency, or is at least as safe and effective as products already in the market. Among the medical devices to win approval under the review process this year: a liquid bandage, electronic blood pressure monitor and powder-free latex patient examination gloves.
The IOM, which was commissioned for the analysis, will consider how well the process protects patients and promotes innovation and what changes, if any, would improve results, according to an FDA press release. Meanwhile, the FDA Center for Devices and Radiological Health will undertake its own review "to evaluate and improve the consistency of FDA decision making", according to the release.
Janet Trunzo, executive vice president of technology and regulatory affairs for the Advanced Medial Technology Association, in a written statement, urged the IOM to include experts in medical device innovation and regulation. Trunzo praised the FDA's approval process as "well-defined, science-driven method" and said she believed the review would underscore strengths of the existing system.
The study's results are expected to be released in March 2011.
Melanie Evans / HITS staff writer
Monday, September 21, 2009
Sebelius announces new food safety Web site
The Obama administration is rolling out a new Web site designed to streamline food safety information for consumers.
Health and Human Services Secretary Kathleen Sebelius announced the new Web site — http://www.foodsafety.gov — on Wednesday during the Consumer Federation of America's food policy conference. The site will put food-related information from all federal agencies in one place, including recall and contamination alerts and tips on how to safely handle food.
The Web site is a joint effort between HHS, the Department of Agriculture and the Food and Drug Administration.
Sebelius says the site would help consumers who have been worried about product recalls.
The consumer Web site is the second federal initiative announced in as many days on food safety. On Tuesday, the FDA announced more stringent rules for reporting potential contaminations and the creation of a new electronic database for manufacturers to use to report food safety issues.
Under the new rules, producers are required to report products that could harm consumers within 24 hours.
The law creating the database was passed in 2007, after Congress criticized the FDA for its handling of safety problems involving a variety of food and drugs.
By HENRY C. JACKSON
September 9, 2009
Source: Associated Press
Health and Human Services Secretary Kathleen Sebelius announced the new Web site — http://www.foodsafety.gov — on Wednesday during the Consumer Federation of America's food policy conference. The site will put food-related information from all federal agencies in one place, including recall and contamination alerts and tips on how to safely handle food.
The Web site is a joint effort between HHS, the Department of Agriculture and the Food and Drug Administration.
Sebelius says the site would help consumers who have been worried about product recalls.
The consumer Web site is the second federal initiative announced in as many days on food safety. On Tuesday, the FDA announced more stringent rules for reporting potential contaminations and the creation of a new electronic database for manufacturers to use to report food safety issues.
Under the new rules, producers are required to report products that could harm consumers within 24 hours.
The law creating the database was passed in 2007, after Congress criticized the FDA for its handling of safety problems involving a variety of food and drugs.
By HENRY C. JACKSON
September 9, 2009
Source: Associated Press
FDA Announces Public Hearing on Internet Promotion
After years of refusing to craft Internet-specific policies, the FDA did an abrupt about-face today by announcing a public hearing on the matter.
In a Sept. 21 notice in the Federal Register, the agency detailed plans for a public hearing Nov. 12 and 13 in Washington, D.C. The hearing will "help guide FDA in making policy decisions on the promotion of human and animal prescription drugs and biologics and medical devices using the Internet and social media tools," according to the notice.
During a presentation at a Food and Drug Law Institute-sponsored conference Monday morning, Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, explained that the agency’s goal is to "eventually issue a draft guidance" on the matter.
The announcement follows years of industry complaints about the lack of guidance in the online realm. Those complaints came to a head this spring when the agency crafted 14 Untitled Letters chastising companies for their handling of sponsored links online.
For additional coverage of the FDA initiative, see upcoming issues of the FDA Advertising and Promotion Manual newsletter.
September 21, 2009
Source: FDA.gov
In a Sept. 21 notice in the Federal Register, the agency detailed plans for a public hearing Nov. 12 and 13 in Washington, D.C. The hearing will "help guide FDA in making policy decisions on the promotion of human and animal prescription drugs and biologics and medical devices using the Internet and social media tools," according to the notice.
During a presentation at a Food and Drug Law Institute-sponsored conference Monday morning, Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, explained that the agency’s goal is to "eventually issue a draft guidance" on the matter.
The announcement follows years of industry complaints about the lack of guidance in the online realm. Those complaints came to a head this spring when the agency crafted 14 Untitled Letters chastising companies for their handling of sponsored links online.
For additional coverage of the FDA initiative, see upcoming issues of the FDA Advertising and Promotion Manual newsletter.
September 21, 2009
Source: FDA.gov
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