Tag Archives: food and drug administration

Accountability Office Questions FDA’s Recall Procedures

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The Government Accountability Office released a report that questions the Food and Drug Administration’s plans for how they will force food recalls. The FDA was granted the power to force a food recall, however they have yet to proclaim how exactly they plan to do so. They believe the Food Safety Modernization act did not properly require the agency to release details about how it will handle a recall. “FDA officials told us that they have not decided whether they will do so and that FSMA contains no such requirement,” according to the GAO report. They recommend the FDA guide the industry and clarify exactly how it plans to implement forced food recalls, especially since the Food Safety Modernization Act allowed them to force recalls. In the past, they could shut-down a company but they couldn’t force them to enact a recall.

The report also suggests finding better ways to inform the public about a recall. The study was released based on an order by the GAO. It also asks the FDA to devise ways to compensate a company if they falsely accuse a company of an unsafe product. They state several important factors to releasing information about recalls, including making sure they’re accurate yet timely. One particular industry leader had no big concerns. “Everybody knows (FDA) has recall authority but they have never used it and never needed it,” said David Gombas, senior vice president of food safety and technology for Washington, D.C.-based United Fresh Produce Association. “I’ve not seen any issues on recall communications.” He said that recall communications are viewable by the public, and the Modernization Act requires the FDA to post notices in stores.  “I know they are working with the retail industry now to figure out how to best to do that,” he said. “My concern with that is that overcommunication can be just as bad as undercommunication if after a while consumers simply get numb and they don’t look at it.”

Stores can always inform customers about recalls if they have loyalty accounts established, such as Costco or Wegman’s. Government leaders also believe insurance or a dedicated program can help compensate companies that are accused of a food safety problem. “Individuals GAO interviewed said that a potential advantage of a dedicated program would be assurance to industry that a mechanism would be available, but a potential disadvantage may be that in lean budget times, funding for such a program may be difficult to obtain,” according to the report.

Report Makes Recommendations for FDA’s Recall Procedures

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A report was recently released that recommends the Food and Drug Administration communicate recalls better. The Government Accountability Office released the report in order to reform food safety, which they deem risky and requiring fixes. They noted in the report the FDA should protect health, and also understand that food recalls effect food industriues. “When [foodborne illness] outbreaks are discovered, prompt responses from government and companies in the food distribution chain–the network of handlers, suppliers, and others involved in the production of food–can play a vital role in stopping the spread of illnesses and keeping the food supply safe; delays can result in more illnesses, as well as deaths,” reads the report. “If unwarranted, however, advisories about adulterated or misbranded food products and recalls of those products can trigger serious economic losses for the food industry and discourage the consumption of healthful food, such as fresh produce.”

The report indicates the FDA should devise guidance on its authority concerning food safety, along with issuing details about how the recall process operates. The Food Safety Modernization Act gave the agency new control, which they rarely use. Most recalls are still voluntary. The FDA should provide details on its recall process along with timelines. They should also remain accurate and develop trust with the public, according to the report.

FDA Holds Meeting to Discuss Failing Hip Implants

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A two-day meeting is being held by the Food and Drug Administration in order to critically analyze metal-on-metal implants for those failing hips. The replacement hips were implanted in nearly half a million Americans, and were found to fail earlier than they should. The metal implants were suggested to not wear as quickly and be less likely to dislocate, although data shows otherwise. “Hip replacements are supposed to last between 10 to 15 years, but more than 6 percent of patients with metal hips needed them replaced after less than five years,” according to CBS News. Research also shows that those who received the implants should get blood tests in order to see if metal components have entered their blood stream. “In my personal opinion there is very little room, if any, for metal-on-metal implants because the alternatives we have on the market are likely safer and as effective,” said Dr. Art Sedrakyan, professor of public health at Weill Cornell Medical College in New York.

As a personal injury attorney, I highly advise that everyone with a metal-on-metal hip implant make an appointment with their doctor in order to check for potential failure or other symptoms caused by wear and tear. If you or someone dear to you believe you were adversely affected by an unsafe product, discuss your claim with an attorney who can evaluate your case and help protect and defend your rights.

Urgent Prescription Recall Announced

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After the environmental sampling of the clean room by the U.S FDA, the presence of microorganisms and fungal growth was revealed. Based on this information,  Franck’s Pharmacy has decided to recall all human and veterinary sterile preparations that have left their control from November 21, 2011 to May 21, 2012. If any of these sterile preparations are in the possession of a customer, it is essential that they do not use them and that they immediately destroy all such sterile preparations and all remaining portions of such sterile preparations. If they do not follow these instructions, and any adversely affects are sustained, the problem should be reported to Franck’s Compounding Pharmacy and FDA’s MedWatch program, according to news reports.

As a personal injury attorney, I hope that nobody is harmed by this unsafe product. Please check to see if you have it in your possession and make sure it is thrown away or returned as soon as possible. If you or someone dear to you was adversely affected by an unsafe product such as this, you may want to get in touch with an attorney who can evaluate your case and help protect your legal rights. An attorney can help you with any questions you may have and fight hard for you in order to get the best possible results for your case. With a lawyer by your side, you’re more likely to get deserved results.

Food Safety Group Reports Improvement

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A report composed by the Food Safety Working Group shows that food safety is gradually improving. “We’re well on our way to building a modern food safety system,”  said Health and Human Service’s Secretary Kathleen Sebelius. The group was created in 2009 to oversee food safety activities by President Obama. One in six Americans experience a foodborne illness every year, said the Centers for Disease Control and Prevention. According to a report in the Institute of Medicine, the Food and Drug Administration has not been adequately preventing foodborne illness.

Food safety is also being improved by the Food Safety Modernization Act, which improved the ability to detect outbreaks sooner, and enforce safety at food processing plants. Another policy developed by the USDA requires that meat facilities hold products until they can be determined safe enough for selling. A report by the Centers for Disease Control shows the rate of E. coli contamination is decreasing, although salmonella is increasing. The Food Safety Modernization Act, a $1.4 billion bill, also allowed the FDA to issue recalls if contaminated foods are not recalled by the company. Food sellers and manufacturers are also required to inform customers who purchased the recalled product, according to news reports.

As a personal injury lawyer, I hope nobody is harmed by a contaminated or defective product. If you or a loved one are adversely affected due to an unsafe product, discuss your case with a Silver Spring personal injury lawyer.

Frozen Eggs Recalled for Salmonella

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American Egg Products is recalling frozen egg products because they may be tainted with Salmonella. The product was distributed to three distributors. They come in five pound paper cartons, with a lot number printed across the side. No illnesses have been reported in connection to the product. The problem was discovered during a routing testing by a private lab that found the product contained Salmonella. The company and Food and Drug Administration are investigating the recall.Those who purchased this product are being asked to return them to wherever they were purchased in order to receive a full refund, according to news reports.

As an auto accident lawyer in Columbia, I hope that nobody is adversely affected by this product. If you or a loved one were harmed by an unsafe product, discuss your case with a personal injury lawyer who can evaluate your claim, assess your case, and answer any important legal questions you may have regarding your case. A personal injury lawyer can help guide you through your case by guiding you through the legal processes associated with your case in order to reach the best possible outcome for your claim.

Chopped Romaine Recalled by True Leaf

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90 cartons of chopped romaine are undergoing a recall by True Leaf Farms due to a potential contamination of Listeria. The product was recalled that shipped between September 12-13. There have not been any illnesses linked to the recalled product yet. The affected product has a use-by date of 9/29/11. The recalled lettuce was packed in True Leaf Farms cartons then distributed to various retail outlets. The company was notified today that the lettuce was taken during a random sampling and tested positive for Listeria. The Food and Drug Administration is working with True Leaf Farms to let consumers know about the recall. “We are fully cooperating with the FDA, and we are contacting all of our customers to ensure prompt removal of any product potentially associated with the recall,” said Steve Church, True Leaf Farms. “We are committed to conducting this recall quickly and efficiently to reduce any risk to public health.” According to news reports, costumers are urged to throw the lettuce away immediately.

As a car accident lawyer, I hope that nobody is adversely affected by this product. If you or a loved one were harmed by an unsafe product, discuss your case with an Alexandria personal injury attorney who can evaluate your claim, assess your case, and answer any important legal questions you may have regarding your case. A personal injury lawyer can help guide you through your case by helping you through the legal processes in order to reach the best possible outcome for your claim.

Listeria Outbreak in Cantaloupe Sickens Many

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Contaminated cantaloupe has been linked to a listeria outbreak in Colorado, Texas, and Nebraska. 12 have become ill while one has died from the sickness. The specific brand of cantaloupe has not been identified, and the Centers for Disease Control and Prevention is investigating along with the Food and Drug Administration in order to research the illness. Listeria can cause food poisoning, and those with weakened immune systems are especially susceptible. According to Consumer Reports, cantaloupes are difficult to clean since the bacteria hides out in the nooks and crannies in its outer skin. Consumers should always scrub the outside surface before eating.

As a car accident lawyer, I hope that nobody is adversely affected by this product. If you or a loved one were harmed by an unsafe product, contact a Germantown personal injury lawyer who can evaluate your case and help protect your rights, along with answer any important legal questions you may have regarding your claim.

FDA, Industry Reach Agreement on Generic Drug Fees

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Media sources reported that the US Food and Drug Administration (FDA) and generic drug manufacturers reached a compromise agreement on a user-fee program that requires the companies to pay around $299 million the first year to speed up the drug approval process.

The FDA has been negotiating with the generic drug industry since February of this year to establish a user-fee program that mirrors the one in place for brand-name drugs and medical devices. The program allows companies to pay the FDA extra money to hire more staff and improve support systems for its drug review process, and some of the fees would pay for bulking up the FDA inspection of US and foreign manufacturing facilities. The agreement met requires that the companies fund the user-fee program in full starting in year one. The $299 million or more a year, when adjusted for inflation, would include a one-time payment from those companies whose drugs are still pending review in the FDA’s application backlog.

The US generic drug industry accounts for more then two-thirds of the prescriptions filled in the country and have become a formidable rival to brand-name drugs that are facing expiring patents. With larger revenues, the industry is more willing to pay for faster approval of their products. It is also eager to improve the FDA inspection process to avoid the scandals that have occurred in the past.

As an Arlington personal injury lawyer, I’m glad to hear that these companies are willing to help improve the FDA’s approval process. As a reader, do you consider it a conflict of interest that the same companies being inspected are footing the bill, or do you think that it’s only natural that they should have to pay if they want a faster process? If you’ve been injured through the consumption of a defective drug product, call a personal injury lawyer in your area to discuss your case.

Papaya Recalled for Salmonella

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A papaya recall was issued by Agromod Produce, Inc. 97 cases of salmonella contamination have been reported. 10 of those cases resulted in hospitalization. The recalled papayas were imported from Mexico. They were distributed across the country before July 23. Papaya samples tested positive for differing strains of salmonella. Currently, the FDA is working with state authorities to ensure that papaya is not sold to the public. They are also working to determine how they became contaminated in the first place. The FDA is advising that consumers check the label on any fresh papayas they may have purchased. Throw them away immediately if you own the affected produce.

According to news reports, the FDA is working with Agromod to determine how the contamination began. As a Germantown car accident lawyer, I hope that nobody is adversely affected by this product. If you or a loved one were hurt by a defective product, discuss your case with a Germantown personal injury attorney who can evaluate your claim, assess your case, help defend your rights, and answer any legal questions you have concerning your case.