A seeming inability of the Food and Drug Administration to properly police pharmaceutical factories in other countries has led some lawmakers to offer up a solution.
A Pennsylvanian Congressman has put forth a bill that would provide critical funding to allow the FDA to conduct more inspections in drug factories abroad. The bill, known as H.R. 3988, would accomplish this by placing a fee on United States-based makers of generic drugs. The Congressman said that drug makers are behind him on the plan, so long as it means that inspections can be carried out and drugs can make their way onto shelves quicker.
To that end, the bill also aims to speed through the long line of generic drugs currently trying to get approved by the FDA. It does this by putting money toward the backlog. If passed, the proponent of the bill thinks that the 30 month approval process could be made more expedient.
The Congressman touting the bill referred to the recent contaminated heparin situation making headlines as the type of thing that could be prevented if the FDA were given more foreign inspection power. According to him, just shy of $300 million would go to the FDA by instituting the new fee on domestic generic drug producers.
The House Energy and Commerce Committee passed the bill last week.
The presence of carbendazim, a fungicide prohibited by American health regulations, has prompted the United States Food and Drug Administration to prevent just three additional shipments of imported orange juice within the past month.
In total the FDA has prevented 30 orange juice shipments from being imported into the United States since the government health regulator began its testing program at the beginning of this year, according to a recent FDA press release. That number includes two shipments from Costa Rica; 14 shipments from Brazil; 12 shipments from Canada, which utilizes Brazilian juice in its orange juice products; and one shipment apiece from Poland and the Dominican Republic.
The recent reduction in product banning would suggest that foreign exporters have begun testing orange juice product shipments for traces of carbendazim and sending these shiments to locations that allow the fungicide if they test positive for residues greater than the ten parts per billion ratio allowed by the FDA standard. The FDA began testing for the presence of carbendazim when Minute Maid and Tropicana, the two highest selling orange juice brand names in the United States, informed the agency they had detected small quantities of carbendazim in their products.
As a Fresno personal injury attorney, I am hopeful that the FDA’s new stricter testing policy will help to prevent any consumer illness that might result from the presence of an illegal fungicide in American food products. If you or someone you care about has been made ill by improperly manufactured food products, please consider contacting a Bakersfield personal injury attorney.
Even as studies continue to be carried out and hypotheses tested, the Food and Drug Administration has come out and said that they can find no evidence that BPA would pose a danger to humans.
This issue has risen to the fore in recent months and years, with consumer advocates pointing to animal studies that they say showed an increased risk of diabetes, cardiovascular disease, and reproductive issues when animals were exposed to Bisphenol A. The FDA, however, has said that after reviewing studies, they can find nothing that would suggest this damage would carry over to people.
BPA has been used to make plastics and small levels of it may be found in cans and plastic bottles. As a result, trace amounts of BPA can be transferred to food and drink. Hundreds of studies have been conducted testing whether this could be dangerous, but the FDA has said they have looked into these studies and concluded that a diet with these trace amounts of BPA would not pose a risk.
The FDA goes even further than that, as a matter of fact, taking to task a previous claim that infants are exposed through an inordinate amount of BPA in their foods. They have instead said that in babies and adults alike, BPA gets metabolized and ejected from the body.
As a personal injury lawyer in Los Angeles, I’ve seen numerous people affected by dangerous chemicals. No matter what the decision is on BPA, I will be paying attention as a San Francisco personal injury lawyer to examinations of all chemicals by the FDA and consumer advocates.
According to news sources, the Food and Drug Administration has announced that a Chicago based ready-to-eat sandwich maker has shut down manufacturing after a repeated history of violations and a reported Listeria outbreak.
The company, Triple A Services Inc., has announced the closure of of the manufacturing facility after agreeing to stop producing and distributing its ready-to-eat sandwiches. The agreement also stipulates that the company hire a sanitation expert to oversee the company’s sanitation program and ensure its compliance with existing FDA safety regulations.
There have been no illnesses to date relating to the consumption of the company’s sandwich products.
The company’s manufacturing facility reportedly experienced a Listeria monocytogenes outbreak recently, helping prompt the decision to close the facility. Listeria can cause severe or even fatal infections to those with weak immune systems, the elderly and children.
As a Los Angeles personal injury lawyer, I urge you to be mindful of threats from food-borne bacteria. Consumers that have purchased a known defective product should stop using it immediately. If you or a loved one have been injured by a defective product, I urge you to contact a product liability lawyer Los Angeles to learn about your legal options.
According to news sources, the Food and Drug Administration has just given approval to InfraScan Inc. of Philadelphia to begin marketing the first non invasive hand-held device to be utilized in detecting bleeding skulls.
The device, named the Infrascanner Model 1000, uses near-infrared spectroscopy to help identify bleeding in the skull. Health care providers will be able to utilize the device to extract crucial information about the patient. In conjunction with other clinical information, the healthcare provider can then determine the need for further diagnostics, by using for example a CT scan.
The device utilizes a certain wavelength of light that is capable of penetrating both bone and tissue and transmit the crucial information to a handheld computer.
An FDA review found that the device was able to detect up to 75 percent of hematomas cases that CT scans detected.
As a personal injury lawyer Los Angeles, I appreciate all efforts made to ensure higher safety standards to protect those injured in collisions and accidents on the roadway. The conclusions of this innovative endeavor seem to suggest that the detection time of bleeding skulls will be shortened in some cases by utilizing this device. As a Los Angeles personal injury attorney, I hope that supplying this information will help people stay safe.
According to news sources, safety concerns regarding the drug Pradaxa have led The Food and Drug Administration to caution healthcare providers about the safety of the drug after a large scale clinical trial found “serious bleeding events” related to the drug.
The FDA is currently in the process of attempting to identify if the drug causes more bleeding than what has commonly been expected. In a clinical trial including 18,000 patients found that those who took Pradaxa and warfarin experienced similar rates of major bleeding with both drugs, an FDA report said.
The Pradaxa label warns against significant or fatal bleeding associated with the dug.
The FDA has also said that patients with atrial fibrillation should continue taking the drug since stopping it would increase their risk of stroke.
Patients who have experienced any adverse effects due to the drug are encouraged to contact the FDA at 1-800-332-1088.
As a personal injury lawyer Los Angeles, I’m glad to see that research is continually being conducted to provide safer and more advanced drugs for the treatment of patients. I hope patients will find the conclusions of this study useful. If you or someone you care about has been injured or suffered from the use of an unsafe product, I recommend you contact a product liability lawyer Los Angeles as soon as possible.
