Fight Over Health Risk Warnings for Generic Drugs

Generic drug makers are fighting proposed FDA regulation that would require them to warn patients of each drug’s health risks.

The Los Angeles Times reports that this regulation would also close a legal loophole and allow patients to sue not only brand-name drug manufacturers, but also generic drug makers.

In 2009, the Supreme Court made a sharp distinction between brand-name drugs and lower-cost generics, the latter making up the majority of mediations that Americans buy. The court ruled that brand-name drug makers could be sued if they failed to warn patients that a drug carried a potential health risk.

That decision upheld a $7-million jury verdict for a patient whose lower arm was amputated after she was injected with an anti-nausea drug made by Wyeth. A health risk of that drug was gangrene if injected into an artery.

On the other hand, the high court dismissed a recent case with a generic drug that had also caused side effects that included disfigurement, burns and near-blindness. Justice Clarence Thomas reasoned that because federal regulations say generics must be exact copies of the approved brand-name drugs, their makers cannot revise or update warning labels when new risks come to light. He added that they cannot be sued for failing to warn consumers.

In order to fix this problem, the FDA proposed in November to allow generic makers to change their warning labels when reports of new problems arise. The agency cited a need for them to be able to “independently update product labeling to reflect certain newly acquired safety information,” and also to have “independent responsibility to ensure its product labeling is accurate and up-to-date.”

According to Ralph G. Neas, president of the Generic Pharmaceutical Association, this regulation “would be nothing short of catastrophic.” He claims it could raise health care costs and “create dangerous confusion” for doctors and patients.

Generics have lowered many Americans’ health care costs, according to Neas, and he plans to fight the FDA with a national public education campaign.

Meanwhile, the drug companies that manufacture the painkillers OxyContin and Opana are trying to block generic drug makers’ efforts to produce cheaper versions of the drugs. They argue these newer drugs will not have the tamper-resistant designs used in making the brand-name pills.

The FDA’s original timing to complete the proposal has been postponed until March in response to complaints from the generic drug makers.