In a June 2013 decision, the Supreme Court ruled that a state’s law could not be contrary to federal laws regarding prescription medicines approved by the Food and Drug Administration (FDA). This decision sparked concerns about patient safety. Responding to a September 5, 2013 opinion in the Wall Street Journal entitled “Innovator Liability, Take Two,” Burton LeBlanc, President American Association for Justice Washington, expressed his concern.
Brand versus generic
A new drug developed by a manufacturer must be approved by the FDA before being sold. The manufacturer will patent the new drug, and thereby have exclusive rights to the formula. Upon expiration of the patent, other manufacturers may begin producing generic versions of the medication. The generic manufacturer must comply with all of the regulations required by the FDA. The generic manufacturer does not have to bear the cost of research and development and, therefore, can sell at a lower cost.
Under the FDA’s rules, these generic versions must be exactly the same as the brand name version. Not everyone agrees the drugs are the same. LeBlanc states his concern that there is disparity in accountability that creates an issue with patient safety. LeBlanc agrees with the Wall Street Journal that creation of new FDA regulations is a step in the right direction.
Correcting the imbalance
LeBlanc argues that allowing drug producers to update warning labels on generic drugs will help to restore the accountability imbalance between generic and brand drugs. The vast majority of medications prescribed in the United States are generic. LeBlanc points out that manufacturer accountability when drugs kill or harm patients is vital for patient safety.
Put Our Experience to Work for You
Bad drug lawsuits can be a complex and lengthy process. Depending on whether the injury results from a brand name or a generic drug can make a difference in how to proceed. When a Florida resident falls prey to a bad drug, they may want to seek out more information from a Tampa injury lawyer. The law offices of Abrahamson & Uiterwyk offer a free initial consultation and case evaluation. Call 1-800-753-5203 today.
Because of the fact that cases involving pharmaceutically caused injuries may be highly complex and exceedingly specific, our law firm commonly works with other law firms who have considerable experience in each particular case type. Thus, we may be referring these types of cases to a separate firm, with whom we typically associate and work with on a co-counsel basis.