30.01.2012 15:00:00
Stade spoke first in a spirited debate between former FDA and current consultant Philip J. Phillips, Esq., President, Phillips Consulting Group, LLC, Professor Ralph F. Hall, Professor of Practice, University of Minnesota Law School, and Partner, Lauren R. Silvis, Esq., Sidley Austin LLP. Section 513 of the Food, Drug, and Cosmetic Act ("FD&C Act") mandates that, prior to marketing, FDA must classify all medical devices into one of three classes depending on the intended use, indications for use, and level of control necessary to ensure the safety and effectiveness of the device. Class I requires the least control, followed by class II, and class III requires the most control. Section 513(i) of the FD&C Act essentially states that if a new device is substantially equivalent to an already-marketed device or "predicate" device, the new device is given the same classification as the device already in the market and may be submitted as a "510(k)" submission, which is based on section 510(k) of the FD&C Act. If the new device is not substantially equivalent to any such device, the new device is placed in class III and requires a premarket approval application ("PMA") under Section 515 of the FD&C Act.
Over the years, the 510(k) process has become the most common and controversial pathway for bringing medical devices to market. FDA's definition of medical device includes products ranging from simple tongue depressors to pacemakers to laser surgical devices. Under the current 510(k) process, device manufacturers must notify FDA of their intent to market a medical device at least 90 days prior to launch. If FDA determines that the device is substantially equivalent to an existing 510(k) cleared device or other device that was on the market when the Medical Device Amendments were enacted in 1976, then it may proceed to market. If not, it must undergo pre-market approval as a premarket approval application ("PMA").
2012-01-31 14:15:18
According to documents recently released by federal courts, the U.S. Food and Drug Administration (FDA) allegedly spied on its own employees. The organization is charged with secretly accessing the private e-mail accounts of staff researchers who criticized the agency for approving medical equipment that posed a potential safety risk to patients. A group of six doctors and scientists, all either current or former employees of the federal health agency, filed a lawsuit in a U.S. District Court in D.C. last week alleging that the organization attempted to prevent its own experts from releasing potentially incriminating reports about corrupt practices in the agency’s review process for new medical equipment. All of the plaintiffs were part of an FDA division in charge of reviewing applications for new medical technology. According to the recently released documents, FDA chiefs started intercepting the e-mails sent by the whistleblowers to members of Congress after they had initially made their concerns known to the Obama administration in early 2009. Although using government computers to communicate with congressional staff members, the dissenting researchers reportedly used their own private e-mail accounts with Google and Yahoo. Moreover, the FDA allegedly used spyware software in order to obtain snapshot images of the whistleblower’s computer screens which were in turn used to make illicit copies of their private communications and identify other staff members who were assisting them. In an article published Monday in the Washington Post, the newspaper noted that FDA computers warn all users when they log in that they have “no reasonable expectation of privacy.” The researchers filing the charges, however, have stated that the FDA’s surveillance tactics violated their constitutionally guaranteed privacy rights and that they were intended to obstruct legitimate whistleblowing activity. “Who would have thought that they would have the nerve to be monitoring my communications to Congress?” one of the plaintiffs in the suit Robert C. Smith told the Washington Post. “How dare they?” added the indignant former radiology professor at Yale and Cornell universities. Smith was employed by the FDA until the agency decided not to renew his contract in July 2010. FDA spokeswoman Erica Jefferson has stated only that the agency does not comment on ongoing litigation. In addition to approving medical equipment that researchers had flagged as dangerous, the plaintiffs also say that the FDA attempted to retaliate against them by refusing to renew their employment contracts—as was the case with Jefferson—as well as by accusing them of criminal malfeasance. After airing their complaints about agency’s dubious approval practices to the New York Times in March2010, the FDA attempted to launch a criminal investigation against the whistleblowers, claiming that they had unlawfully released confidential business information. The FDA’s allegations were shot down by independent federal investigators who noted that the reported activity was legal and that the charges lacked evidence. As the investigation grows into a public scandal, legislators have belated begun registering their disapproval. In an official statement made last week, Republican Senator Charles Grassley of Iowa said: “The FDA has a huge responsibility to protect public health and safety [and] it’s hard to see how managers apparently thought it was a good use of time to shadow agency scientists and monitor their e-mail accounts for legally protected communications with Congress.” --- On the Net:
01.02.2012 18:51:18
Rep. John Dingell: A lot of our prescription drugs come from overseas. The FDA needs the authority to monitor foreign suppliers to prevent counterfeit or contaminated drugs from entering our market.
01.02.2012 16:44:26
http://www.fda.gov/Safety/Recalls
Important news for women using oral birth control products. Pfizer is recalling about one million packets of birth control pills in the United States because they may not contain enough contraceptive to prevent pregnancy.
"As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy," according to a Pfizer statement on
the U.S. Food and Drug Administration website.
Monthly doses contain 28 tablets total... 21 with contraceptive and 7 sugar pills. The pharamceutical company discovered that some of their blister packs had too many active tablets, some had too few and some had the tablets out-of-order.
Related:
7 Amazing Health Benefits of Sex
The recall involves 14 lots of Lo/Ovral-28 tablets and 14 lots of Norgestrel and Ethinyl Estradiol tablets.
A company spokesperson told The Associated Press that the problem is the result of both mechanical error and a failure on the packaging line during visual inspections.
The pills in question were distributed nationwide.
Lot numbers of affected packs of Lo/Ovral®-28 (norgestrel and ethinyl estradiol)Tablets and Norgestrel and Ethinyl Estradiol Tablets (generic) follow on the table below:
| NDC |
Product |
Lot |
Expiration |
Configuration/Count |
|---|---|---|---|---|
| 24090-801-84 | LO/OVRAL® 28 | E15678 | 08/31/2013 | 6 Pilpacks® of 28 tablets each |
| 24090-801-84 | LO/OVRAL® 28 | E15679 | 08/31/2013 | 6 Pilpacks® of 28 tablets each |
| 24090-801-84 | LO/OVRAL® 28 | E15686 | 08/31/2013 | 6 Pilpacks® of 28 tablets each |
| 24090-801-84 | LO/OVRAL® 28 | E15687 | 01/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-801-84 | LO/OVRAL® 28 | E15690 | 01/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-801-84 | LO/OVRAL® 28 | E15698 | 01/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-801-84 | LO/OVRAL® 28 | E15700 | 02/28/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-801-84 | LO/OVRAL® 28 | E80434 | 07/31/2013 | 6 Pilpacks® of 28 tablets each |
| 24090-801-84 | LO/OVRAL® 28 | E80438 | 08/31/2013 | 6 Pilpacks® of 28 tablets each |
| 24090-801-84 | LO/OVRAL® 28 | F36908 | 02/28/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-801-84 | LO/OVRAL® 28 | F36909 | 02/28/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-801-84 | LO/OVRAL® 28 | F43915 | 03/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-801-84 | LO/OVRAL® 28 | F43926 | 03/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-801-84 | LO/OVRAL® 28 | F43927 | 03/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | E15677 | 08/31/2013 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | E15704 | 01/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | E15706 | 01/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | E80440 | 08/31/2013 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | F16388 | 01/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | F16390 | 02/28/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | F22132 | 02/28/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | F31330 | 02/28/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | F36911 | 03/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | F36913 | 03/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | F43924 | 03/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | F43925 | 03/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | F43934 | 03/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | F53238 | 03/31/2014 | 6 Pilpacks® of 28 tablets each |
http://www.fda.gov/Safety/Recalls/ucm289770.htm
###
More from
GalTime:
01.02.2012 12:59:06
Saying a New York cheese maker failed to correct repeated violations, despite multiple federal and state warnings, the U.S. Food and Drug Administration has gone to court to close down the plant until it complies with food safety regulations.
Mexicali Cheese of Woodhaven, NY produced cheese under persistent unsanitary conditions that contributed to Listeria monocytogenes contamination of the facility and the company's products, the FDA alleges in a complaint for permanent injunction filed Monday by the U.S. Department of Justice.
According to the FDA news release, Mexicali Cheese makes and distributes a variety of soft Mexican cheeses to grocery stores and supermarkets in New York, New Jersey and Connecticut. Mexicali Cheese's products include queso fresco [fresh cheese], queso oaxaca (Oaxacan cheese) and queso para freir [cheese for frying].
In October 2010,
an FDA warning letter said inspectors found Listeria monocytogenes in at least five locations inside the Mexicali processing facility. In August that year, the New York Department of Agriculture warned consumers not to eat any Queso Cotija Cheese from Mexicali because of possible Staphylococcus aureus contamination.
The injunction, if entered by the court, would stop the company and its officers from manufacturing and distributing food until they can bring their operations into full compliance with the Federal Food, Drug, and Cosmetic Act and FDA food safety regulations.
"FDA filed this complaint to protect the health of consumers," said Dara A. Corrigan, associate commissioner for regulatory affairs, in the agency's statement. "Working closely with New York's Department of Agriculture and Markets, we took this step to ensure that consumers do not eat potentially dangerous foods from this company."
Mexicali Cheese of Woodhaven, NY produced cheese under persistent unsanitary conditions that contributed to Listeria monocytogenes contamination of the facility and the company's products, the FDA alleges in a complaint for permanent injunction filed Monday by the U.S. Department of Justice.
According to the FDA news release, Mexicali Cheese makes and distributes a variety of soft Mexican cheeses to grocery stores and supermarkets in New York, New Jersey and Connecticut. Mexicali Cheese's products include queso fresco [fresh cheese], queso oaxaca (Oaxacan cheese) and queso para freir [cheese for frying].
In October 2010,
an FDA warning letter said inspectors found Listeria monocytogenes in at least five locations inside the Mexicali processing facility. In August that year, the New York Department of Agriculture warned consumers not to eat any Queso Cotija Cheese from Mexicali because of possible Staphylococcus aureus contamination.
The injunction, if entered by the court, would stop the company and its officers from manufacturing and distributing food until they can bring their operations into full compliance with the Federal Food, Drug, and Cosmetic Act and FDA food safety regulations.
"FDA filed this complaint to protect the health of consumers," said Dara A. Corrigan, associate commissioner for regulatory affairs, in the agency's statement. "Working closely with New York's Department of Agriculture and Markets, we took this step to ensure that consumers do not eat potentially dangerous foods from this company."
01.02.2012 12:59:01
As Food Safety News continues to investigate the identity of 'Restaurant Chain A,' the "Mexican-style fast food chain" linked to a
10-state outbreak of Salmonella enteritidis infection in October and November 2011, the issue has received mounting attention from a variety of media outlets and blogs, including
the Huffington Post and
Marion Nestle at Food Politics.
JoNel Aleccia of msnbc.com
spoke with Dr. Robert Tauxe, the Center for Disease Control and Prevention's Deputy Director of Foodborne, Waterborne and Environmental Disease. In the interview, Tauxe explained the government's rationale behind withholding the name of the restaurant, a practice he said the CDC and Food and Drug Administration regularly follow in similar outbreaks.
The agencies' longstanding policy has been to identify companies linked to outbreaks only when the information will directly protect public health, such as in the case of an ongoing outbreak. The CDC also wants to avoid jeopardizing cooperation with companies that voluntarily release information during outbreak investigations.
In this case, according to the CDC the CDC and FDA chose not to identify the restaurant because the outbreak ended before investigators had enough information to release a report. In other words, no more people were at risk of catching the bug by the time the agencies pinpointed it.
Food safety attorney Bill Marler, who publishes Food Safety News,
dismissed that reasoning, noting that nearly all CDC investigations discover the source of an outbreak after the peak illnesses have passed. Identifying outbreak-associated restaurants reveals their food safety track record over time, he added.
To some food safety and public health experts, the ramifications of withholding the restaurant's identity extend beyond potentially harming a company's reputation.
Dave Theno, the former vice-president of technical services for Jack in the Box, said that identifying the restaurant in an outbreak lets related businesses respond accordingly, perhaps in ways government agencies would not predict. The Salmonella infections have been traced to a product -- likely fresh produce -- served at Restaurant A, but contaminated before it arrived.
"Let's say I own a restaurant and I happen to know my lettuce supplier also supplies Restaurant A. In the real world, as soon as the lettuce supplier hears from Restaurant A, he's going to call all his customers to tell them what's happening," Theno said. "But people don't always see every outbreak and don't always get notified. There are a lot of gaps in the system, to be quite honest."
Theno said that if other restaurant owners shared a mutual supplier with Restaurant A, they might not know they ever carried a contaminated product unless the government identified the outbreak's source.
Theno also wondered whether Mexican-style fast food restaurants not involved in the outbreak might suffer economic harm. By revealing only the type of chain, public health agencies might cause consumers to avoid all types of Mexican-style chains out of caution.
Craig Hedberg, Ph.D., professor of environmental health at the University of Minnesota, said that in the initial stages of an epidemiological investigation, revealing the name of an outbreak source can create unnecessary complications for the researchers. Not only do investigators want to be absolutely certain they pinpoint the right source, they need time to interview and vet victims before the public and the media scrutinize and otherwise influence the investigation.
Once the investigation has confirmed its source and an outbreak report is ready, however, the benefits of nondisclosure become less relevant, Hedberg said.
More importantly, he added, by not revealing itself, Restaurant A is missing an opportunity to publicly acknowledge and correct its mistake.
"We certainly all understand that foodborne illnesses occur and nobody wants to see that happen," Hedberg said. "But in the years I investigated outbreaks with the Minnesota Department of Health, our experience was that when a food producer or restaurant could stand up say, 'Yes, the outbreak happened, and this is what we're doing to prevent it again,' the public responds positively to that."
"Rather than run from the outbreak, the company needs to stand up and say, 'We can't always prevent everything, but this gives us a chance to review our practices and redouble our efforts to make sure this doesn't happen again,'" he added. "That almost always goes well with the public. You have to give credit to the public for understanding."
Hedberg referenced the 1994 outbreak of Salmonella enteritidis infection linked to Schwan's ice cream, made from ice cream mix contaminated in a supplier's tanker trucks. Despite not being directly culpable, Schwan's took responsibility and pledged to reform its food safety standards.
"Schwan's changed their processes in response to that outbreak and have become an important leader in the food safety arena since that time," Hedberg said."They weren't responsible, but rather than hiding from the public, they used that opportunity to really remake their whole food safety system."
Similarly, Theno instrumentally reformed Jack in the Box's food safety practices following the 1993 outbreak of E. coli O157:H7 linked to undercooked ground beef at their restaurants. He said the Restaurant A outbreak might provide an opportunity to reevaluate the precedent of nondisclosure for similar outbreaks moving forward.
"I've worked with Robert Tauxe and the FDA for years. I understand exactly where they are, but I don't happen to agree with it all," Theno said. "Perhaps it's time to look at this whole issue again, not in the crux of an outbreak, but with calm minds and with all the interested parties at the table and ask, 'Is there a better way to do this?' I don't have an answer to that, but I think it would serve everyone well."
10-state outbreak of Salmonella enteritidis infection in October and November 2011, the issue has received mounting attention from a variety of media outlets and blogs, including
the Huffington Post and
Marion Nestle at Food Politics.
JoNel Aleccia of msnbc.com
spoke with Dr. Robert Tauxe, the Center for Disease Control and Prevention's Deputy Director of Foodborne, Waterborne and Environmental Disease. In the interview, Tauxe explained the government's rationale behind withholding the name of the restaurant, a practice he said the CDC and Food and Drug Administration regularly follow in similar outbreaks.
The agencies' longstanding policy has been to identify companies linked to outbreaks only when the information will directly protect public health, such as in the case of an ongoing outbreak. The CDC also wants to avoid jeopardizing cooperation with companies that voluntarily release information during outbreak investigations.
In this case, according to the CDC the CDC and FDA chose not to identify the restaurant because the outbreak ended before investigators had enough information to release a report. In other words, no more people were at risk of catching the bug by the time the agencies pinpointed it.
Food safety attorney Bill Marler, who publishes Food Safety News,
dismissed that reasoning, noting that nearly all CDC investigations discover the source of an outbreak after the peak illnesses have passed. Identifying outbreak-associated restaurants reveals their food safety track record over time, he added.
To some food safety and public health experts, the ramifications of withholding the restaurant's identity extend beyond potentially harming a company's reputation.
Dave Theno, the former vice-president of technical services for Jack in the Box, said that identifying the restaurant in an outbreak lets related businesses respond accordingly, perhaps in ways government agencies would not predict. The Salmonella infections have been traced to a product -- likely fresh produce -- served at Restaurant A, but contaminated before it arrived.
"Let's say I own a restaurant and I happen to know my lettuce supplier also supplies Restaurant A. In the real world, as soon as the lettuce supplier hears from Restaurant A, he's going to call all his customers to tell them what's happening," Theno said. "But people don't always see every outbreak and don't always get notified. There are a lot of gaps in the system, to be quite honest."
Theno said that if other restaurant owners shared a mutual supplier with Restaurant A, they might not know they ever carried a contaminated product unless the government identified the outbreak's source.
Theno also wondered whether Mexican-style fast food restaurants not involved in the outbreak might suffer economic harm. By revealing only the type of chain, public health agencies might cause consumers to avoid all types of Mexican-style chains out of caution.
Craig Hedberg, Ph.D., professor of environmental health at the University of Minnesota, said that in the initial stages of an epidemiological investigation, revealing the name of an outbreak source can create unnecessary complications for the researchers. Not only do investigators want to be absolutely certain they pinpoint the right source, they need time to interview and vet victims before the public and the media scrutinize and otherwise influence the investigation.
Once the investigation has confirmed its source and an outbreak report is ready, however, the benefits of nondisclosure become less relevant, Hedberg said.
More importantly, he added, by not revealing itself, Restaurant A is missing an opportunity to publicly acknowledge and correct its mistake.
"We certainly all understand that foodborne illnesses occur and nobody wants to see that happen," Hedberg said. "But in the years I investigated outbreaks with the Minnesota Department of Health, our experience was that when a food producer or restaurant could stand up say, 'Yes, the outbreak happened, and this is what we're doing to prevent it again,' the public responds positively to that."
"Rather than run from the outbreak, the company needs to stand up and say, 'We can't always prevent everything, but this gives us a chance to review our practices and redouble our efforts to make sure this doesn't happen again,'" he added. "That almost always goes well with the public. You have to give credit to the public for understanding."
Hedberg referenced the 1994 outbreak of Salmonella enteritidis infection linked to Schwan's ice cream, made from ice cream mix contaminated in a supplier's tanker trucks. Despite not being directly culpable, Schwan's took responsibility and pledged to reform its food safety standards.
"Schwan's changed their processes in response to that outbreak and have become an important leader in the food safety arena since that time," Hedberg said."They weren't responsible, but rather than hiding from the public, they used that opportunity to really remake their whole food safety system."
Similarly, Theno instrumentally reformed Jack in the Box's food safety practices following the 1993 outbreak of E. coli O157:H7 linked to undercooked ground beef at their restaurants. He said the Restaurant A outbreak might provide an opportunity to reevaluate the precedent of nondisclosure for similar outbreaks moving forward.
"I've worked with Robert Tauxe and the FDA for years. I understand exactly where they are, but I don't happen to agree with it all," Theno said. "Perhaps it's time to look at this whole issue again, not in the crux of an outbreak, but with calm minds and with all the interested parties at the table and ask, 'Is there a better way to do this?' I don't have an answer to that, but I think it would serve everyone well."
31.01.2012 11:00:00
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: New Cystic Fibrosis Drug Approved by FDA
2012-01-31 06:22:43
Johnson & Johnson have announced a voluntary recall for its Aveeno Baby Calming Comfort Lotion. According to tests performed by the Food and Drug Administration (FDA), the lotion contained an excessive amount of the common bacteria coagulase-negative Staphylococci. But an independent laboratory, EMSL, tested the samples and did not find any indication that the number of bacteria exceeded specifications. Jason Dobranic Ph.D., National Microbiology Director at EMSL says, “As one of the nation’s leading testing laboratories, EMSL Analytical offers companies advanced microbiology testing services for their consumer products in cases such as these. We help companies deal with quality-control issues and recalls, and because we are an FDA registered, cGMP compliant, and IS) 17025 accredited laboratory, our clients know that they can rely on our results.” The bacteria is commonly found living on the skin, scalp, and mucous membranes of humans. And is also commonly found in cosmetic products but is not considered a health threat. The company is recalling 2,200 tubes of the lotion containing the lot number 0161LK. The tubes were sold in nine states Alabama, Arkansas, Florida, Georgia, Kansas, Louisiana, Mississippi, Tennessee, and Texas. The recall is voluntary and no ill effects have been reported. The chance of any ill effects is very slim, according to Johnson & Johnson. They will offer consumers a refund, but the recall states, “Consumers do not need to take action and the potential for adverse health effects is remote. Of course, anyone who has concerns or is uncomfortable using the product may discontinue us.” According to the Johnson & Johnson press release the full product name recalled is Aveeno Baby Calming Comfort Lotion with the UPC code 38137-0036456. Johnson & Johnson’s Consumer Call Center can be reached at 1-877-298-2525. --- On the Net:
31.01.2012 17:01:25
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: FDA Sued Over Secret Surveillance of Employees A lawsuit by a group of scientists and doctors who worked at the U.S. Food and Drug...
01.02.2012 8:00:00
(The Translational Genomics Research Institute) A new skin cancer drug tested for the first time in the world five years ago at the Virginia G. Piper Cancer Center at Scottsdale Healthcare just received expedited approval by the US Food and Drug Administration, a remarkable accomplishment in new drug development.
31.01.2012 17:20:28
Federal regulators on Monday approved a pill that treats the most common type of skin cancer, basal cell carcinoma. The pill is called Erivedge and is made by Genentech, a unit of Swiss drugmaker Roche.
01.02.2012 11:00:00
On Monday, the US Food and Drug Administration approved a new type of drug to treat adult patients with advanced basal-cell carcinoma, the most common type of skin cancer. The drug's generic name is vismodegib and was developed by the US part of Roche Holding AG. It will be sold in the US by Roche's South San Francisco-based Genentech under the brand name Erivedge. Basal cell carcinoma is a slow growing, painless cancer that starts in the epidermis, the top layer of skin. It usually starts in places that are regularly exposed to the sun or UV light...
30.01.2012 20:01:02
The FDA approved Amylin Pharmaceuticals' diabetes drug Bydureon after a prolonged regulatory process to address safety concerns.
01.02.2012 12:59:07
With the ongoing economic crisis there has been a need for governments across the globe to cut budgets. Food safety lacks the tangible benefits of, say, health care and it was somewhat inevitable that food inspection agencies would experience the brunt of such cutbacks.
In the United Kingdom, the Food Safety Agency that was established in the wake of the "mad cow" disease outbreak, amongst other food safety scares, was essentially dismantled with its portfolio being returned to Ministry of Agriculture (DEFRA).
In Canada, the number of CFIA inspectors was increased following the listeriosis outbreak of 2008 in which contaminated deli meats resulted in 20 deaths. However, the Canadian government is now cutting over 200 inspectors in a bid to save $25 million from the federal budget.
In the United States, the cutbacks have been deeper, with over 260 USDA offices being closed for a savings of $150 million per year.
In reaction, many consumer groups, the press and unions have pronounced the cutbacks as placing the public in danger through the governments neglecting their responsibilities.
The old question is thus posed: Does more government involvement, specifically in relation to inspector numbers, lead to a more effective food safety system?
A similar question is posed by criminologists in relation to police numbers and crime rates. Those on one side of the argument use statistics to show that an increase in police numbers results in decreased crime rates. However, what is missed is that an increase in policing is commonly preceded by a major event, such as 9/11 or when pre-existing crime levels are high.
In other studies, where no major event has occurred, it has been found that there is no correlation between police on the ground and crime rates.
The theory goes that high numbers of police on the ground lead to an increased level of crime detection but do little to prevent crime from occurring. As sociologists will indicate, crime rates are mostly affected by the environment, such as socio-economic factors and community cohesion - in effect the existing culture. To take the argument further, it is thought that increasing the level of policing can bring a siege-like atmosphere to a community and negatively affect the community cohesion.
Returning to food safety, we can make parallels between the effect of policing on crime rates and superimpose on the number of food inspectors and foodborne illness outbreaks. Specifically, inspector numbers increase or reorganization of agencies occurs following a major foodborne illness outbreak.
Yet, what is missed is that in the event of an outbreak, it is the industry response that is primarily responsible for enhancing food safety and not visits by an army of food inspectors. Nevertheless, food inspection does play a major role in containing outbreaks and follow-up investigations, although this is different from prevention.
Industry-led initiatives are the only way to enhance food safety
In the 1980s, there was a diverse range of food safety issues of concern. Foodborne illness rates were increasing, virulent pathogens such as E. coli O157 were taking hold, not to mention the BSE and problems with the emergence of drug-resistant microbes.
In response, a directive from President Clinton's administration set to prioritize food safety risks, reduce red tape and bureaucracy. The directive essentially empowered the industry to take responsibility for food safety by introducing HACCP, amongst other initiatives.
There is little debate that the initiatives were highly successful in reducing the incidence of foodborne illness with a progressive decrease in numbers since implementation.
A more recent example of industry-led initiatives is in relation to the use of antibiotics in animal production. Antibiotics have been commonly used in animal production to prevent infections, thereby leading to high growth rates. However, a negative effect of antibiotics has been the emergence of lethal antibiotic strains of pathogens such as Salmonella, amongst others.
The FDA has debated the banning of antibiotics for promoting animal growth for over 30 years. In late 2011, the FDA somewhat unexpectedly stepped back from banning antibiotics in animal production, which is counter to the actions taken over in the EU.
Many commentators saw this as a capitulation of the FDA to the lobbying pressure from the meat industry. However, the reality is that the meat industry has been proactive in reducing the use of antibiotics in animal production on the understanding that a staged reduction is required. Of course, this is not well-publicized but illustrates that only a successful antibiotic reduction program can be achieved if led by industry and not by government.
Empowerment of food safety is the key
The empowerment of industry to self-regulate always comes under criticism in the event of a foodborne illness outbreak. The knee-jerk reaction always appears to be more testing, more inspectors, more agencies etc.
In many ways, "tinkering" with the food safety system by government hinders the progress that has been made since 1995. Ultimately, industry-led initiatives will always be the most effective approach to improve food safety. Consequently, rather than increasing government inspection a more productive strategy is how to remove the weak links in the chain to prevent outbreaks from occurring in the first place.
Such a strategy is far from straightforward, as there is a need to understand the underlying basis for decisions made that ultimately led to critical errors of judgment in foodborne illness outbreaks.
For example, why do processors send out product known to be contaminated or perform practices that represent obvious food safety risks? In a broad sense, it can be proposed that the actions are through ignorance (lack of knowledge is perhaps a better term) of the risk, economic factors or, in a relatively low number of instances, bioterrorism or criminal intent.
Ironically, it is the latter group who have the greatest perception of empowerment given they are controlling events. In contrast, those that lack knowledge may have good intentions in producing high quality products, although fail to see the consequences. It is almost akin to a thought pattern of "nobody told me not to do it."
The current trend of clean labels, along with producers of organic products, can be classed in this group, where attempts to produce additive-free foods leads to food safety risks (for example, omitting nitrites to control Clostridium botulinum). Also included in this group are food handlers, quality assurance personnel and management whose main focus is to produce product as fast as possible with little thought of ownership or empowerment.
Workers have a tendency to lack empowerment, as they are told what to do and when to do it. This ultimately leads to a disconnect between the product and food safety. In the processing environment, workers are judged on how quickly the product can be processed regardless if the production line is producing ready-to-eat deli meat, cars or paper-clips.
Even if food violations occur, there is little incentive for the worker to raise concerns or to be empowered to make suggestions. When visiting processing plants, I sometimes ask the workers if they consume the products produced in the facility. In the majority of cases, the answer is no, due to their prior knowledge of the history of the product. Clearly those workers have a disconnect or lack of ownership with the product.
Akin to when the industry is highly regulated by government, the lack of empowerment by food workers throughout an organization ultimately leads to essentially passing-the-buck when it comes to food safety - an "it is not my problem" attitude.
It could be argued that empowerment is encompassed in the concept of a food safety culture. Yet "food safety culture" remains a relatively woolly term that lacks the nuts-and-bolts on how to change the behavior of those working in the food industry. There is frequent reference to increasing knowledge by training. However, knowledge and empowerment are very different.
Frank Yiannas introduced the term food safety culture, and noted the major challenges in changing worker behavior - after all, it does take a generation. Still every road starts with a first step and rather than look at the loss of government inspectors as entering the Dark Age we should look at this as an opportunity for industry to be empowered to take food safety initiatives to the next level.
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Dr. Keith Warriner is an Associate Professor within the Department of Food Science at University of Guelph, Canada.
In the United Kingdom, the Food Safety Agency that was established in the wake of the "mad cow" disease outbreak, amongst other food safety scares, was essentially dismantled with its portfolio being returned to Ministry of Agriculture (DEFRA).
In Canada, the number of CFIA inspectors was increased following the listeriosis outbreak of 2008 in which contaminated deli meats resulted in 20 deaths. However, the Canadian government is now cutting over 200 inspectors in a bid to save $25 million from the federal budget.
In the United States, the cutbacks have been deeper, with over 260 USDA offices being closed for a savings of $150 million per year.
In reaction, many consumer groups, the press and unions have pronounced the cutbacks as placing the public in danger through the governments neglecting their responsibilities.
The old question is thus posed: Does more government involvement, specifically in relation to inspector numbers, lead to a more effective food safety system?
A similar question is posed by criminologists in relation to police numbers and crime rates. Those on one side of the argument use statistics to show that an increase in police numbers results in decreased crime rates. However, what is missed is that an increase in policing is commonly preceded by a major event, such as 9/11 or when pre-existing crime levels are high.
In other studies, where no major event has occurred, it has been found that there is no correlation between police on the ground and crime rates.
The theory goes that high numbers of police on the ground lead to an increased level of crime detection but do little to prevent crime from occurring. As sociologists will indicate, crime rates are mostly affected by the environment, such as socio-economic factors and community cohesion - in effect the existing culture. To take the argument further, it is thought that increasing the level of policing can bring a siege-like atmosphere to a community and negatively affect the community cohesion.
Returning to food safety, we can make parallels between the effect of policing on crime rates and superimpose on the number of food inspectors and foodborne illness outbreaks. Specifically, inspector numbers increase or reorganization of agencies occurs following a major foodborne illness outbreak.
Yet, what is missed is that in the event of an outbreak, it is the industry response that is primarily responsible for enhancing food safety and not visits by an army of food inspectors. Nevertheless, food inspection does play a major role in containing outbreaks and follow-up investigations, although this is different from prevention.
Industry-led initiatives are the only way to enhance food safety
In the 1980s, there was a diverse range of food safety issues of concern. Foodborne illness rates were increasing, virulent pathogens such as E. coli O157 were taking hold, not to mention the BSE and problems with the emergence of drug-resistant microbes.
In response, a directive from President Clinton's administration set to prioritize food safety risks, reduce red tape and bureaucracy. The directive essentially empowered the industry to take responsibility for food safety by introducing HACCP, amongst other initiatives.
There is little debate that the initiatives were highly successful in reducing the incidence of foodborne illness with a progressive decrease in numbers since implementation.
A more recent example of industry-led initiatives is in relation to the use of antibiotics in animal production. Antibiotics have been commonly used in animal production to prevent infections, thereby leading to high growth rates. However, a negative effect of antibiotics has been the emergence of lethal antibiotic strains of pathogens such as Salmonella, amongst others.
The FDA has debated the banning of antibiotics for promoting animal growth for over 30 years. In late 2011, the FDA somewhat unexpectedly stepped back from banning antibiotics in animal production, which is counter to the actions taken over in the EU.
Many commentators saw this as a capitulation of the FDA to the lobbying pressure from the meat industry. However, the reality is that the meat industry has been proactive in reducing the use of antibiotics in animal production on the understanding that a staged reduction is required. Of course, this is not well-publicized but illustrates that only a successful antibiotic reduction program can be achieved if led by industry and not by government.
Empowerment of food safety is the key
The empowerment of industry to self-regulate always comes under criticism in the event of a foodborne illness outbreak. The knee-jerk reaction always appears to be more testing, more inspectors, more agencies etc.
In many ways, "tinkering" with the food safety system by government hinders the progress that has been made since 1995. Ultimately, industry-led initiatives will always be the most effective approach to improve food safety. Consequently, rather than increasing government inspection a more productive strategy is how to remove the weak links in the chain to prevent outbreaks from occurring in the first place.
Such a strategy is far from straightforward, as there is a need to understand the underlying basis for decisions made that ultimately led to critical errors of judgment in foodborne illness outbreaks.
For example, why do processors send out product known to be contaminated or perform practices that represent obvious food safety risks? In a broad sense, it can be proposed that the actions are through ignorance (lack of knowledge is perhaps a better term) of the risk, economic factors or, in a relatively low number of instances, bioterrorism or criminal intent.
Ironically, it is the latter group who have the greatest perception of empowerment given they are controlling events. In contrast, those that lack knowledge may have good intentions in producing high quality products, although fail to see the consequences. It is almost akin to a thought pattern of "nobody told me not to do it."
The current trend of clean labels, along with producers of organic products, can be classed in this group, where attempts to produce additive-free foods leads to food safety risks (for example, omitting nitrites to control Clostridium botulinum). Also included in this group are food handlers, quality assurance personnel and management whose main focus is to produce product as fast as possible with little thought of ownership or empowerment.
Workers have a tendency to lack empowerment, as they are told what to do and when to do it. This ultimately leads to a disconnect between the product and food safety. In the processing environment, workers are judged on how quickly the product can be processed regardless if the production line is producing ready-to-eat deli meat, cars or paper-clips.
Even if food violations occur, there is little incentive for the worker to raise concerns or to be empowered to make suggestions. When visiting processing plants, I sometimes ask the workers if they consume the products produced in the facility. In the majority of cases, the answer is no, due to their prior knowledge of the history of the product. Clearly those workers have a disconnect or lack of ownership with the product.
Akin to when the industry is highly regulated by government, the lack of empowerment by food workers throughout an organization ultimately leads to essentially passing-the-buck when it comes to food safety - an "it is not my problem" attitude.
It could be argued that empowerment is encompassed in the concept of a food safety culture. Yet "food safety culture" remains a relatively woolly term that lacks the nuts-and-bolts on how to change the behavior of those working in the food industry. There is frequent reference to increasing knowledge by training. However, knowledge and empowerment are very different.
Frank Yiannas introduced the term food safety culture, and noted the major challenges in changing worker behavior - after all, it does take a generation. Still every road starts with a first step and rather than look at the loss of government inspectors as entering the Dark Age we should look at this as an opportunity for industry to be empowered to take food safety initiatives to the next level.
------------------------
Dr. Keith Warriner is an Associate Professor within the Department of Food Science at University of Guelph, Canada.
31.01.2012 23:09:30
The FDA approved a drug developed by Roche and Curis to treat advanced cases of basal cell skin cancer.
31.01.2012 21:00:00
FOR IMMEDIATE RELEASE - January 30, 2012 - Vitaflo USA has announced a voluntary recall of Renastart 14.11 oz (400g) cans, Batch Number 12832 (shown on underside of can), because some of the product shipped throughout the United States during the period December 29, 2011 through January 26, 2012 has been incorrectly labeled. Renastart is a powdered medical food used in the dietary management of pediatric renal disease, for patients one year and older in the United States. All other Vitaflo products, including Renastart cans in batches other than 12832 and Renastart packed in sachets, are not affected in any way. Some immediate consequences of using the incorrectly labeled product may result in high potassium blood levels (hyperkalemia) or high sodium levels in the blood (hypernatremia). In most cases, symptoms may be hard for an individual to detect, but can result in significant health consequences potentially leading to death, which is the importance for contacting a health care professional. Longer term consequences can result in increased levels of calcium, phosphorus, and protein. There have been no cases of illness or other adverse effects reported to Vitaflo USA. Following a customer complaint regarding the way the product was dissolving, Vitaflo determined that a small number of cans of a different product may have been wrongly labeled as Renastart. The company is investigating to make sure we continue to safely meet the needs of our patients and as a precautionary measure has issued this immediate voluntary recall. For the complete recall notice, please visit http://www.fda.gov/Safety/Recalls/ucm289658.htm?source=govdelivery
01.02.2012 5:46:33
The FDA approved a new medicine treat an underlying cause of cystic fibrosis, a pill that targets a genetic mutation affecting a small minority of patients suffering from the breathing disorder.
30.01.2012 20:00:20
U.S. regulators approved Pfizer's Inlyta drug for treating advanced kidney cancer, the latest of several drugs to be approved for the disease in recent years.
01.02.2012
Kalydeco has been approved by the Food And Drug Administration (FDA) to treat a vicious type of Cystic Fibrosis (CF). CF is a deadly recessive disease which targets the lungs, but can also harm the liver, pancreas, and intestine. It occurs from the unusual transport of chloride and sodium across the epithelium, causing mucus buildup in the lungs, and thick secretions. In turn, many respiratory problems occur in patients with CF. Diabetes is also common among patients with CF and it is most common among Caucasians...
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