Authorizing manufacturers of generic drugs to update safety labels independently, without waiting for Food and Drug Administration (FDA) approval or for the brand name equivalent to change its label, is a sensible rule proposed by the FDA and will give both patients and doctors more timely warnings of emerging risks and allow patients to hold generic drug companies liable in court, said Sarah Rooney, Director of Regulatory Affairs for the American Association for Justice, in a recent New York Times editorial.
The opinion piece was prompted by strong opposition to the plan by generic drug makers who fear lawsuits from patients harmed by undisclosed side effects caused by their drugs. Currently, generic drug labeling is required to be the same as the labeling already approved for the brand name equivalent. Because this law does not give label control to generic drug makers, a Supreme Court ruling in 2011 said that generic drug companies cannot be sued under state law for failing to warn consumers of new side effects. This leaves consumers harmed by generic drugs no recourse.
The FDA’s proposed new rule would allow generic drug companies to use the same process for labeling their drugs as the brand-name drug makers. Generic drug makers argue that exposing them to personal injury lawsuits would result in higher drug costs to the consumer.
“Public Citizen, a consumer advocacy group based in Washington that has been pushing the agency to make the change, believes there will be little or no confusion and suggests that the liability costs will not be large because prompt safety updates should help to prevent injuries from occurring in the first place,” Rooney writes.
“Now that generics constitute the vast majority of prescriptions, their manufacturers should be made responsible for alerting the public to risks discovered after their drugs are on the market.”
Source: NY Times