When we purchase over-the-counter drugs or pick up a prescription, we expect that those pharmaceutical products have been tested and are safe for use. Despite our trust in the Food and Drug Administration, there are thousands of patients every year who are injured or lose their lives to dangerous drugs. The FDA is not only responsible for approving drugs, but also withdrawing drugs from the market when they are discovered to be dangerous.
In a recent move, the FDA has advised patients and healthcare providers to avoid the compounding pharmacy NuVision. Problematically, the compounding pharmacy and similar companies are not subject to FDA standards. Our New York medical malpractice attorneys are experienced in complex claims involving pharmaceutical injury and are effective in the investigation of dangerous pharmaceutical products. We are also dedicated to bringing awareness to consumers regarding potential drug dangers faced in the marketplace.
Compounding pharmacies are intended to make individual products to order per prescription. But according to the FDA, many of these compounding pharmacies will perform as a large and independently operated bulk manufacturing centers. Due to oversights in the law surrounding FDA oversight, these compounding companies are often able to evade laws and inspections.
In a recent report, the FDA has disclosed that sterility in products manufactured by NuVision cannot be guaranteed. The pharmacy claims that it does not have to meet FDA standards and can therefore continue to produce, market and sell custom pharmaceutical compounds. Though the FDA can put consumers on notice, the challenge illustrates the difficulties that the FDA has in regulating similar pharmacies.
Though the FDA cannot recall the products, it has issued a statement to providers and patients that they should not use the products because their sterility is not guaranteed. FDA officials also recommended that healthcare professionals, including doctors, nurses, and other staff check their medical supplies for NuVision products. The FDA also advised quarantining the products and never to use them on patients. NuVision has issued its own statement refusing these accusations, but claiming that it does not have to conform to FDA standards.
Sterility in products can mean life or death for patients. One of the leading causes of injury in hospitals is related to infection and bacteria. The products in this case include needles and other injectables that must be certifiably stable for use. The FDA claims that NuVision has had problems in the past with unsterile products. After a fungal infection linked to a single pharmacy last year, the FDA has recharged its efforts in getting more regulatory authority.
According to NuVision, the pharmacy will not recall its products and claims that products are sent to a third-party for sterility testing. The medical products company also claims that it is not required to follow FDA standards for manufacturing. Because of the lack of oversight, the FDA has been urging Congress to give it the authority to regulate compound pharmacies like NuVision. Currently, the FDA cannot recall products, but can only issue statements to providers.
The Law Offices of Nicholas Rose, PLLC offers free consultations. Call 1-877-313-7673.
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Medical Malpractice Watch: Hospitals Profit from Hospital-Acquired Infections, New York City Nursing Home Injury Lawyer Blog, August 16, 2013
Negligent Nursing Home Dental Care Leads to Greater Health Problems, New York City Defective Products Lawyer Blog.
