A proposed FDA rule on labeling generic drugs could increase generic drug-makers’ exposure to product-liability lawsuits. This could add $4 billion a year to the cost of generic drugs, according to Scott Gottlieb, MD, and colleagues.
- A new regulation proposed by the Food and Drug Administration will compel generic drug makers to update their drug labels to reflect purported “new” safety issues.
- The regulation will result in increased drug prices and leave generic drug firms vulnerable to “failure to warn” tort suits, but produce no public health benefit.
- It would be far more efficient and effective for the FDA to either review and update generic drug labels itself or adopt a more rational and logical oversight process, known as Prior Approval Supplements. Either approach would allow updating of drug labels without additional tort liability.
Generic drugs are approved by the FDA via an “abbreviated” process that allow generic drug-makers to copy brand-name drugs without replicating the entire, expensive, research & development process. In exchange, the label has to read the same as the brand-name label. To have different labels for different versions of the same drugs would be a step into strange regulatory territory.