During a congressional hearing, the Food and Drug Administration proclaimed they would like to have greater authorities over drug makers, such as the company based in Massachusetts that created injections which led to many deaths due to fungal meningitis. The owner of the compnay refused to testify during the hearing, using his constitutional rights. The co-founder, Barry Cadden, of the New England Compounding Center appeared at the hearing held by the House Energy and Commerce oversight subcommittee. During the meeting, when asked if he’d like to discuss how he dealt with the outbreak, he denied to talk. The outbreak resulted in the deaths of as few as 32 people.
“Under advice of counsel, I respectfully decline to answer under basis of my constitutional rights and privileges, including the 5th Amendment,” he stated, using his rights to not self-incriminate. His attorney said there have been ongoing investigations into the company, which prevented him from testifying. The outbreak remains under investigation. Many agree that actions should be taken to prevent another outbreak, including improved safety regulations. The products sold by the New England Compounding Center are distributed across the country. However, chances are low that they will be able to address the issue due to the many issues currently being tackled, including taxing and spending.
“I was stunned and angered to learn that an inspection of the NECC by the FDA and the Mass Board over 10 years ago identified contamination in the very same drug at issue in the current outbreak,” Rep. Fred Upton (R-Mich.), chairman of the House Energy and Commerce Committee, said. “Ten years later, we are in the midst of an unthinkable, worst-case scenario.”
The head of the Food and Drug Administration agreed that the problem has grown out of control. She said the cases have been tragic, and the need for a new direction is strong. Currently, compounding pharmacies are regulated by a state, and they produce the medication as requested by a doctor. The manufacturer is subject to federal regulation, and makes a large amount of the drugs due to the needs of the market. Many regulators argued to have the NECC’s license removed because they acted like a manufacturer. With the introduction of new legislation, it would help determine where to draw the line. NECC was “clearly a manufacturer and not a compounder,” argued Rep. Morgan Griffith (R-Va.). “This was not a small compounding pharmacy, but a manufacturer under the law.”
Operations by the company were stopped in October after thousands of doses were recalled. Nearly 450 cases were reported, including 32 fatalities, according to news reports.
Tag Archives: fda safety
Salmonella Contamination Causes Recall
This is a food recall posted by the FDA. It is involving a product of Eco Health, Inc. Powder Prebiotic Formula is being recalled. The product would be identified by being labeled florAlign Prebiotic Formula. The recall is occurring because some of the product may have been contaminated with Salmonella. The disease can adversely affect young children and the elderly. Customers can get in contact with Eco Health, inc. via their help line phone number provided in the article.
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Eco Health, Inc Recalls Product Because of Possible Health Risk
Dietary Supplement Recalled for Unapproved Ingredient
EphBurn 25 is undergoing a recall due to an investigation by the Food and Drug Administration which found that the dietary supplement contains an unapproved drug, ephedrine. There are many adverse effects reported by the FDA. “These include elevated blood pressure, rapid heartbeat, nerve damage, muscle injury, and psychosis and memory loss. More serious effects have also been reported, including heart attack, stroke, seizure and death,” according to news reports. Those who purchased this product are urged to stop immediately and contact their healthcare provider if they experienced any adverse effects, according to news reports.
Despite Dangers, Transvaginal Mesh Sold on eBay
The transvaginal mesh implants have many safety issues, however many sellers are trying to get rid of them through eBay to customers who may not know the many dangers associated with them. The product was taken off shelves by C.R. Bard in July when the FDA forced them to undergo trials. One customer faced complications in her pelvic area after using the product. The permanent damage led her to file a claim against the company, according to news reports.
Accountability Office Questions FDA’s Recall Procedures
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.
Cat Food Recalled for Hazardous Ingredient
Arthur Dogswell LLC announced a recall of VitaKitty cat food because the product may contain an ingredient which would lead to anemia. 1,051 cartons of the product was included in the recall. They were distributed across the country from April to June. They have specific lot codes. The defect was discovered during routine sampling done by the Food and Drug Administration. “We are taking this voluntary action because it is in the best interests of our customers and their feline companions,” said Marco Giannini, the company’s CEO and founder. Those who own this product are urged to return it immediately, according to news reports.
Hospira Announces Recall
The FDA has announced that Hospira is recalling certain lots of carboplatin, cytarabine, paclitaxel, and methotrexate. Embedded particles in the neck of the glass vial may be released into the solution and come into contact with the patient receiving the dose. Some symptoms of such an event would be bruising, bleeding, chest pain, respiratory symptoms, rash, inflammation and itching. Hospira has not received any reports of adverse effects related to these lots at this time. Hospira is arranging for the return and replacement of all effected product.
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19 Cases of Bulk Romaine Lettuce Recalled
The F.D.A. does its best to provide updates on food and drug safety for the consumers’ health. Products that aren’t up to health standards are typically publicly recalled. Here, we explore a salmonella poisoning of romaine lettuce. Explore the article so that you are aware of the specifics in this product recall and continue to be safe.
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GlaxoSmithKline Pays $3 Billion Settlement
GlaxoSmithKline agreed to a settlement of $3 billion after pleading guilty for illegally promoting its products. They plead guilty to two counts of introducing misbranded drugs, the other of failing to report proper data to the Food and Drug Administration. This represents the biggest sum of money pain by a drug company for a penalty. They will also be closely watched by officials for five years. “GSK’s sales force bribed physicians to prescribe GSK products using every imaginable form of high priced entertainment, from Hawaiian vacations to paying doctors millions of dollars to go on speaking tours to a European pheasant hunt to tickets to Madonna concerts, and this is just to name a few,” said an attorney. They promoted Paxil for youth despite it not being approved for ages under 18. They promoted Wellbutrin for fixing several disorders, despite it only getting approved for major depressive disorder. The drug company also failed to release data from studies between 2001-2007, according to news reports.
As a personal injury attorney, I look forward to hearing more about this settlement. If you or someone dear to you was adversely affected due to an unsafe product, you may want to get in touch with an attorney if you believe you have a case. With an attorney by your side, they will fight hard to defend and protect your legal rights throughout the case.
Dietary Supplements Recalled for Salmonella
Three dietary supplements were recently recalled due to contamination with salmonella. The Food and Drug Administration announced the recall of Cataplex ACP, Cataplex C, and Pancreatrophin PMG. They were distributed in containers with best-by dates of May 13. There are no other products included in this recall. Salmonella can be potentially fatal for those who become adversely affected. “Consumers who have purchased any of these three products with specific lot codes of L114 are urged to return it to the place of purchase for a full refund. Consumers and health care professionals with questions can contact Standard Process Inc. at 866-397-3237,” according to news reports. Symptoms of salmonella in those without weakened immune systems are nausea, abdominal pain, and vomiting. The company that conducted the recall has stopped producing the product.
As a personal injury attorney, my thoughts are with those adversely affected by this product. I hope that nobody is harmed by an unsafe product such as this. If you or someone dear to you was harmed by a hazardous product, get in touch with an attorney who can evaluate your claim and help protect and defend your legal. An attorney can help you with any issues you may have and work you through the steps associated with your claim. An attorney can helps ensure your legal rights are protected and that you get the results you need for your personal injury case.