Generic Drugs and Defective Drug Claims

 Posted on August 12,2014 in Drugs

A generic drug is an essential option for Americans, as it is sold at a lower cost than a name brand product. In fact, the FDA notes that generic brands can be as much as 85 percent lower in price. However, these lower prices are a direct result of several factors. One of these factors is that generic drug manufacturers are not required to “repeat the costly clinical trials of new drugs.”

With that said, FDA is responsible for protecting public health by “assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.” Under the federal Food, Drug, and Cosmetic Act (FDCA), the “introduction or delivery for introduction” of an any adulterated drug “into interstate commerce” is prohibited. However, there are instances where manufacturers, generic and name brand, circumnavigate the protections in place and thus manufacture, and even distribute, faulty drugs.

One such example of this, according to the FDA, was in 2012, when the United States Department of Justice stepped in to handle several injunctions brought against Ranbaxy, a generic drug manufacturer and Indian corporation. The DOJ, on behalf of the FDA, filed a consent decree of permanent injunction against Ranbaxy and its subsidiary Ranbaxy Inc. for drugs that had been known for non-compliance with U.S. FDA regulations and for falsifying information. The severity of these types of situations was well noted by Stuart F. Delery, the Acting Assistant Attorney General for the Civil Division of the Department of Justice. He stated, “When companies sell adulterated drugs, they undermine the integrity of the FDA's approval process and may cause patients to take drugs that are substandard, ineffective, or unsafe.”

The use of any drug, generic or not, comes with potential risks and side effects, and the FDA works to ensure consumer safety as best as it can. However, adverse reactions can still occur. If you or someone you know has been negatively affected by a generic defective drug in Illinois, the most important step is to contact a Chicago defective drug attorney. Call the law offices of Newland & Newland, LLP, to schedule your initial consultation today.