April 1 The U.S. Food and Drug Administration on Tuesday defended its proposal to require generic drugmakers to update the prescribing information on their products if they become aware of new safety information, a move the industry says will open them to product liability lawsuits and raise drug costs.
Speaking at a hearing before a U.S. House of Representatives health subcommittee, Dr. Janet Woodcock, the FDA's top pharmaceuticals official, said the move is needed to "create parity" between branded and generic drug makers regarding labeling changes.
Generic drugmakers are not currently allowed to alter the labels on their products without prior agency approval since generic drugs are supposed to be the same as their brand name counterparts, from the active ingredient to dose strength to the information on the label. Any changes to the label must be made by the branded company. Generic manufacturers are required to follow suit.
The rationale goes back to the passage of the Hatch-Waxman act of 1984, under which generic drugmakers were exempt from having to conduct expensive clinical trials in humans if they could show, based on laboratory tests, that their drugs were the same as the branded drug that being copied.
The FDA for many years argued that in order to maintain the "sameness" concept, only brand companies should be able to update the labels.
But in 2011 the Supreme Court ruled that the FDA's prohibition on label changes meant generic drugmakers should not be held accountable for failure to warn against risk. As a result, consumers taking a brand name drug can have legal recourse if they are injured by a drug while those taking a generic typically do not.
Now the FDA wants to unshackle generic drugmakers and allow them to make such changes.
Today, more than 80 percent of prescriptions are written for generic drugs. In about 45 percent of cases the branded version is no longer available, which means no company is responsible for updating safety data. Woodcock said the proposed rule would require both generic and branded manufacturer stand behind their products.
"The goal is to make sure the whole system is searching for safety problems and updating labels when they are found," she said.
The generic drug industry is lobbying aggressively against the proposal, and paints a dire picture if the rule were to be finalized.
"The proposed rule would expose generic drug manufacturers to substantial new tort liability costs, which in turn would require them to adjust prices to stay in business, withdraw products, or decline to launch new affordable versions of brand medicines," Ralph Neas, president of the Generic Pharmaceutical Association told the committee.
Proponents of the measure say generic drugmakers will not be taking on any more liability than they did before the Supreme Court ruling three years ago, and they note that prices did not go down with the implied reduction in liability risk after the court's ruling.
"With greater ability to make prompt safety updates, the proposed rule should help avoid liability, as compared to the circumstances prior to June 11," Allison Zieve, general counsel at the drug safety watchdog Public Citizen, said. "The rule will help prevent injuries from occurring in the first place."
(Reporting by Toni Clarke in Washington; editing by Andrew Hay)