Generics Makers Fight Label Change

Generic drug makers are threatening to sue if the Food & Drug Administration finalizes a proposal to revamp warning labels on their products. They contend the planned regulation could jeopardize patient safety and access to affordable medicines.

As proposed, “the rule is bad policy and bad for public health,” says Ralph G. Neas, CEO of the Generic Pharmaceutical Association, the industry’s main trade group. If it is finalized, “we would be forced to go into court.”

FDA says it intends to issue the rule in December to change the complex drug warning system.

When new evidence emerges that a brand-name drug has harmed patients, manufacturers are required to immediately warn doctors and consumers by updating product labels. Companies that make brand-name drugs face significant product liability exposure if they fail to quickly take steps to protect patient safety.

But federal law does not allow generic drug makers to change the safety warnings on their labels until the manufacturer of the branded equivalent has done so and FDA has approved the change. In 2011, the U.S. Supreme Court ruled that generic drug companies are shielded from state lawsuits because of their inability to update warning labels on their own.

FDA says its proposal was prompted by the increased use of generics, which now fill more than 80% of U.S. prescriptions. In many cases, brand-name products are taken off the market after generics competition begins, meaning no company is responsible for keeping labels up-to-date.

Under FDA’s proposal, generics manufacturers would be allowed to independently warn consumers when important new safety information surfaces about one of their drugs. But industry argues that the rule would lead to increased litigation, higher prices, and a confusing array of different warning labels for the same drugs (C&EN, April 21, page 26).

The activist group Public Citizen counters that by giving companies greater ability to make prompt safety updates, the rule would help them avoid liability. Public Citizen petitioned FDA to issue the rule.

Neas says his group wants to work with FDA to find a way to strengthen labeling requirements without hindering patient access to generic medicines.