FDA proposes new rule to allow generic drug makers ability to update safety labels

fda logo FDA proposes new rule to allow generic drug makers ability to update safety labelsThe Food and Drug Administration (FDA) is taking steps to allow manufacturers of generic drugs permission to change safety labels when new information about potential side effects is discovered.

Currently, generic drug makers are required to have the same safety labels as their brand-name counterpart. For years, citizen groups have petitioned the FDA to take measures to ease the regulations that prevent generic drug companies from providing new information about potential risks associated with their products.

Brand-name drugs go through a rigorous approval process through the FDA during which they must provide data from clinical trials demonstrating the drug’s safety and efficacy, and detailing common and potentially dangerous side effects found with use of the drug. Once the drug has been approved for marketing, its label must provide efficacy and safety data. When the drug’s patent expires, generic drug companies can submit products for approval but they must carry the same warnings as their brand-name equivalent.

In many cases, long after a drug has been on the market, drug companies discover new risks associated with the drug. Under current laws, brand-name drug makers can change their safety labels without FDA approval, while generic drug makers cannot update their label unless it meets certain criteria. Makers of generic drugs cannot update their safety labels unless they are ordered to do so by the FDA or if the brand-name equivalent changes its label.

Consumer watchdog group Public Citizen conducted a review of its own and found that 434 generic drugs with no brand-name equivalent were currently on the market. The company also notes that 80 percent of prescriptions filled last year were for generic drugs.

The FDA says that its proposed new rule would allow generic and brand-name drug companies to update their safety labels.

Source: USA Today