According to the latest issue of Pain Medicine News, the FDA is currently exploring the possibility of making a change to pharmaceutical labels. As it currently stands, only brand name medications can update a label’s safety information without the approval of the Food & Drug Administration (FDA). The organization is still debating the proposed rule that would give generic medication manufacturers the same freedom to quickly update the labeling.

The article states that “[r]epresentatives from Public Citizen, the National Center for Health Research, Consumers Union and other entities argued for passage of the FDA rule as written. A parade of individuals harmed by inadequately labeled generic drugs also testified in support, including a woman who lost her hand to gangrene after Phenergan was delivered by IV push and a woman disabled from ciprofloxacin.”

The Supreme Court ruled in Pliva v. Mensing that a generic company cannot be held responsible for omitting potentially serious side effects or warnings “as long as the label matches brand-name labeling.” This holds true even if the company is aware of potential problems.

“Americans assume that they have the same legal protections and most up-to-date safety information regardless of whether their drug is a brand name or not,” says Anna Mazzucco, PhD, scientific advisor at the National Center for Health Research. “The current situation creates a terrible double standard, making patients with generic drugs second-class citizens. … Temporary differences in labeling between generic and brand-name drugs are far outweighed by the benefit to public health that comes from updating labels with drug safety information as quickly as possible.”

One alternative proposed by the Generic Pharmaceutical Association (GPhA) and Pharmaceutical Research and Manufacturers of America includes the requirement of both the generic and brand name companies to submit for FDA approval. Since approval processes can be lengthy, both organizations asked that the FDA create an expedited process.

According to Pain Medicine News, “the FDA would notify all drug manufacturers if it deemed a change was necessary and a labeling change would then be made within 30 days through e-labeling, available via the Internet.”

Increased medical costs remain the major roadblock for the passage of any new legislature. The GPhA estimated in a recent study that the new proposal would increase generic drug spending by 5.4% and cost the government and private spenders $4 billion per year. However, the FDA estimates that cost to be $26,000 annually, but that figure does not include liability costs associated with the labels.

Michael Carome, director of Public Citizen’s Health Research Group, believes slowing down the communication process could make companies less liable. A decision is expected by September 30, 2015.