NEW DRUG LABELING LAW

As the Georgia Injury Lawyer Blog attorneys have writtten about before, prescription drug manufacturers can cause serious personal injuries and death by failure to warn of a prescription drug’s hazardous side effects. A new law requires prescription drug companies to take steps to ensure drug safety and eliminate the risks of needless serious personal injury or death.
In late September, President Bush signed into law the Prescription Drug User Fee Reauthorization Act, PDUFA. This Act creates new federal safety requirements for drug companies, and Congress made it very clear that the bill does not change the burden on drug companies to warn of a drug’s hazards. That duty remains squarely where it belongs, on the drug company, which is in the best position to warn about problems associated with the drug.
The rule of construction, which is included in Section 901 of the Bill, makes it clear that Congress is not altering the responsibility of a drug manufacturer to promptly update its drug label when the manufacturer becomes aware of safety information that should be added to the label. But, it still gives the FDA, Food and Drug Administration, the authority to require label changes and even if the FDA does not act, the burden to warn the public still remains on the drug company.
Under the FDA’s current regulations, a drug company is required to revise its label to include warnings about risks that may be associated with the drug as soon as there is reasonable evidence of that risk. Although the company must notify the FDA of the change, it is not required to wait for the FDA’s approval before making such a labeling change. The theory is that consumers should be made aware of a drug’s risk at the earliest possible moment.
The provision also makes clear that the burden of updating the warning label falls squarely on drug companies. This is the first time that Congress has directly passed legislation concerning labeling. Previously, all labeling requirements were governed by the FDA’s regulations only. These prior regulations, placed many people in the public at danger due to delays or inaction on the part of the FDA.
The drug manufacturers fought and lobbied very hard to include language that Congress specifically left out of the final bill. That language would have shifted the burden of making labeling changes from the drug manufacturers to the FDA.
This bill is a major victory for the public.