One article reported that, “Consumers just lost another potential tool to hold certain drug makers liable for their injuries in a recent move by the Food and Drug Administration (FDA). The reversal at the end of 2018 by the FDA of a previous proposal to protect consumers means that they cannot sue generic drug manufacturers in court for product safety issues.” The basic role of the FDA is to protect “the public health by ensuring the safety, efficacy and security of human and veterinary drugs, biological products and medical devices and by ensuring the safety of [the] nation’s food supply, cosmetics and products that emit radiation.” The FDA regulates food and drug products including the U.S.
pharmaceutical industry; this industry has brand names as well as generic manufacturers that make generic drugs that are generally a lower cost. It has been estimated that over 80% of drugs used in the United States are generics.

“Generic drugs can be substituted for the brand name drugs in many cases by the pharmacy and are designed to be equivalent and often less costly versions of the original brand developed by the brand manufacturer. Brand name drug manufacturers, when developing a new drug, must apply to the FDA for approval of a new product and submit label and clinical information as part of the process. They can later update the label - which contains all the required information - with any new updated product information. Generic drug manufacturers also must file for approval of the drug with the FDA. They file with a version of the brand name information and must also demonstrate conforming to FDA standards that the drug is safe, is pharmaceutically equivalent to the brand name, that they can manufacture it correctly, and other requirements.”

The FDA in 2013 had proposed allowing generic drug manufacturers to update their labelling information when the brand name updated theirs. As a result this allowed consumers to hold generic drug manufacturers legally responsible for their product. However, with the new change the FDA reversed the labelling plan stating that it would have imposed new costs and regulatory burdens on the manufacturers. The inadvertent result of this new change is that patients who use generic drugs will not see label updates and as a result have no legal methods to hold the generic drug manufacturers accountable for any harm or injury that occur from a defective or dangerous product.

Because generic drug manufacturers have received this change they have been saved from a huge potential financial outburst because they are now immune to lawsuits. “The reality is consumers rely on the food and medical products they use to be safe, therefore, without updated labelling consumers are literally blindsided as to what they are using and have no leg to stand on to bring about personal injury claims against the generic drug manufacturers”, one consumer was quoted as saying. One article stated, “In the future congress can develop new legislation addressing this issue; but currently consumers are left with limited options to receive the compensation they deserve for product injuries involving generic drugs.”

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