With the fungal meningitis outbreak rapidly spreading across the nation, many Americans are wary of drug compounding facilities, but they are not the only ones to be worried about. A recent article from the New York Times details just how dangerous the drug manufacturing business is as a whole, and how Americans should be vary wary of all drug manufacturers.
Unlike drug compounding pharmacies, which are not regulated by the Food and Drug Administration (FDA), major manufacturers of sterile injectable drugs are heavily regulated. The FDA regularly performs inspections using federal standards. As a result of these rigorous inspections, six of the major drug manufacturers have been warned by the FDA that they have seriously violated the rules just in the past three years. Some of these violations include rusty tools, mold in production areas, bug infestation and even a barrel of urine. As a result, four have closed their factories or drastically slowed production. Due to this decreased production, more and more drug compounding pharmacies, like the New England Compounding Center, have sprung up to fill in the void. These compounding pharmacies are just as dangerous for our nation, if not more so, as they are not subject to inspections by the FDA.
Apparently, those in the pharmaceutical industry are well aware how poorly the drug manufacturing business is maintained. In fact, Erin Fox, manager of the Drug Information Service at the University of Utah, stated that, “[i]n the industry, everyone knows that all of the factories are in terrible shape.” Our attorneys were shocked to read this and feel that it is unacceptable for the American consumer. These factories are all on American soil and are producing life saving injectable drugs that are used on thousands of ailing patients across the country.
The New York Times reported that some of the targeted companies include Teva, a large manufacturer of generic drugs, and Hospira, the leading manufacturer of injectable drugs. Teva was cited by the FDA for many violations. One of the most egregious was failing to catch bacterial contamination of an anesthesia drug, before it left the factory. Hospira has been the subject of a long list of complaints that include overfilled vials of morphine and faulty machinery, that have lead to major recalls. Other companies that the FDA has cited for violations include Boehringer Ingelheim, Sandoz, Luitpold Pharmaceuticals, and A.P.P. Pharmaceuticals.
The FDA continues to crack down on pharmaceutical plants that manufacture drugs on American soil. These crack downs result in slowed production, therefore increasing the number of drug compounding facilities that have entered the market which are not regulated by the FDA at all. American consumers have the right to be informed that they should not only be wary of products from drug compounding facilities, but of the products from large mainstream facilities as well. Drug manufacturing facilities should be sterile, highly regulated environments that produce only the best drugs for ailing Americans.
The product liability attorneys at our law firm are aware that the administration or injection of contaminated drugs can cause illness, pain, emotional trauma and even death. The conditions at these facilities are nothing more than pure negligence on the part of the companies. Everyday people seek medications and injections from their doctors for pain management, anesthesia, or cancer treatment, just to name a few. If you or a loved one has suffered an injury as the result of receiving a recalled or contaminated medication, please contact our office to explore your legal options.