The Food and Drug Administration is touting its ability to police drugs even after they’ve been approved.
On Saturday, the organization said that the same amount of resources are spent making sure that existing drugs are safe as are spent in the pre-approval stage of a drug’s life. The statement came following critics’ remarks that the FDA isn’t protecting consumers from drugs already on the market. The FDA has said that 385 post-market studies have been launched since 2008, and in that time, the studies have forced companies to change their product’s labels in 65 instances.
Until 2008, drug makers only had to voluntarily institute label changes if requested by the FDA. But there was a change in tide when Congress gave the FDA the ability to institute fines and order label changes on drugs that had already been brought to market. These new powers came two years after the Institute of Medicine released a report suggesting that the FDA could do more to promote product safety post-approval.
2008 was also the year that the FDA launched a program called Sentinel. This program uses computers to track side effects through a number of databases, discovering problems without having to rely on a patient or a company making a report.
As a personal injury attorney in Riverside, I’m glad to see more efforts being made to keep consumers safe from already existing products. It’s always possible that time can prove an item to be unhealthy. New drugs can certainly be hazardous, but as a Ventura personal injury lawyer, I know that existing products can also pose a threat in certain circumstances.
United States Marshals seized a number of supposed cancer curing drugs from a plant in Bogard, Missouri.
The seizure was initiated following a request by the Food and Drug Administration, who investigated the plant in January following a complaint from a consumer. The manufacturer in question, Notions-N-Things Distribution, was responsible for marketing drugs that purported to cure cancer. The FDA has said, though, that these items were not approved by the FDA and may contain ingredients that might be toxic or could pose a danger to those with allergies.
1,600 containers in total were seized by the marshals. The first item removed was chickweed healing salve, which its makers claimed could cure skin cancer, but that contains an ingredient known as comfrey which the FDA says puts the user in danger of contracting systemic toxicity. The next item, To-Mor-Gone, was seized because of the aforementioned lack of approval and because it contains bloodroot. Bloodroot is in fact a corrosive substance which, when applied to human skin, would create a scar that hides a tumor’s presence rather than outright cure it.
The third seized drug, R.E.P., supposedly fights sinus infections and headaches, but its label doesn’t list any ingredients whatsoever, thus not meeting FDA standards.
I know how important the FDA approval process is as a personal injury lawyer in Ventura. Even when companies have a consumer’s best interests at heart, it’s vital that a product is proven safe before it’s distributed to a consumer. Perhaps the makers of these items will now seek FDA approval and the items can come out with the proper labels. As a Bakersfield personal injury attorney, all I care about is that the consumer is safe.
A Washington manufacturer that fell afoul of the Food and Drug Administration has agreed to keep its products away from consumers until the items can be proven safe again.
Beginning in 2009, the Washington State Department of Agriculture and the FDA uncovered a wide variety of sanitary issues at a processing facility run by Del Bueno, a cheese manufacturer. Following these discoveries, a number of their products then tested positive for listeria monocytogenes in 2010. This can cause listeriosis, which can bring about infections, fever, and diarrhea, and is particularly dangerous to pregnant women, the elderly, and young people.
Now, Del Bueno has entered into what’s called a consent decree of permanent injunction with the FDA. The company must now create a program dedicated to combating listeria contamination and prove that it has worked. This includes destroying all items currently in their facility, getting samples tested by an independent lab, and having an independent sanitation expert on hand. Only by following these directives and submitting to a future recall should the need arise can the entity resume business as usual.
The products produced and distributed by Del Bueno were available at restaurants and retail outlets throughout the state of Washington.
It’s sad that a company has to shut its doors, but as a Riverside personal injury attorney, I think it’s better that an issue gets corrected than commerce win out over safety. It’s my hope as a San Jose personal injury lawyer that the contamination becomes nonexistent and the consumer can remain safe.
The Food and Drug Administration is moving forward with plans to shut down a seafood distributor that they say is endangering public health.
A permanent injunction is being sought by the FDA against Fujino Enterprises Inc., more commonly known as Blue Ocean Smokehouse, a company based out of Half Moon Bay.  That injunction would prevent the continued processing and distribution of fish products. The Department of Justice has filed a complaint.
Findings by the FDA have shown that the fish products made by Blue Ocean are adulterated. The conditions used to process these food items fail to comply with Hazard Analysis Critical Control Point regulations, which are supposed to be in place in order to spot hazards and prevent their further occurrence.
The FDA also claims that preparation conditions don’t meet standards set by Current Good Manufacturing Practice requirements, citing an October inspection which showed unsatisfactory employee hygiene and inadequate contamination protection.
In addition, it was discovered that the company’s products may contain a botulism toxin that cannot be removed through heating or freezing. Listeria monocytogenes, an infection causing agent, was also found on various surfaces, and Blue Ocean’s tuna was at risk of contracting scombrotoxin.
All things considered, this seems pretty damning to a San Diego personal injury lawyer like me. When companies fail to comply with the FDA, steps must and will be taken to ensure public safety. As a personal injury lawyer in Riverside, I just hope things get fixed before someone gets hurt.
According to related news articles, the number of drug recalls is higher and higher every year. Allegedly, the pharmaceutical recalls jumped to 150 in the third quarter of 2010 alone. Details from the FDA Enforcement Reports show that the spike in drug recalls may have something to do with the aggressive activity from FDA authorities when it comes to the pharmaceutical industry.
A Medical waste manager notes that while the FDA increases its tough supervision on pharmaceutical supply, consumers worldwide will be directly affected. Safety issues have been of great priority to the FDA in the past years. The nation saw the alleged scandal of two major recalls in the past, Vioxx in 2004 and heparin in 2007. Reports have demonstrated that the agency suffers major pressure from the Congress to keep the supply chain under intensive control.
The FDA states that officials have been trying to reach a deal with generic drug makers. The proposal indicates that foreign plants manufacturing most of the generic products would have to be inspected with a certain frequency.
As a Los Angeles personal injury lawyer I urge all readers to read this blog regularly so they can be aware of all the recall news in the Nation. Personal injury lawyers are always happy to help you with any doubt you may have regarding your personal injury case, do not delay in contacting someone close to you.
