FDA Won’t Issue New Generic Drug Labeling Guidelines this Year

Generic drugs are often preferred by consumers because they are essentially identical to name brand drugs, but can usually be purchased at a fraction of the cost. But one of the protections afforded to purchasers of name brand drugs, the right to sue the drug’s manufacturer if the drug causes the consumer harm, is not afforded to those who are harmed by generic drugs. Now the Food and Drug Administration has chosen not to issue a regulation that would changing this situation until 2017 at the earliest.

An additional implication of the FDA’s delay is that generic drug producers still do not have to take responsibility for warning consumers about the potential dangers of the drugs they produce. This follows a 2011 Supreme Court decision in which the court ruled that generic drug manufacturers could not be punished for failure to warn consumers of the potential dangers associated with consuming the drugs they manufacture because the generic drug companies do not have control of the verbiage used on the warning labels.

Citizens groups and personal injury attorneys, among others, were disappointed by the FDA’s decision to delay the rule promulgation. They hoped that the FDA would act and clarify the current situation in which those who take, and are harmed by, a generic drug may be unable to sue, while those who are harmed by the name brand version of the same drug retain the right to seek legal remedy in court.

The issue has been on the table for several years; the FDA first announced the need to create a level playing field among generic and name brand drugs in 2013. But since then both generic and name brand drug manufacturers have lobbied the FDA, imploring it not to move too quickly on the matter. One argument the manufacturers have offered is that, should the FDA make the proposed rule change and create parity between generic and name brand drugs, a situation could arise in which the same drug formulation could be accompanied by different warning labels – one for the name brand version, and a different label for the generic version.

The drug companies asked for the FDA to have the final word on drug labeling, which could potentially take some of the responsibility off their hands for harmful drugs. Consumer advocates have objected to this request.