Generic drug makers 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.
For many years the FDA argued that in order to maintain the “sameness” concept only brand companies should be able to update the labels, however given the recent proposal that may be subject to change.
Generic Drug Makers Against FDA Proposal
In 2011 the Supreme Court ruled that the FDA’s prohibition on label changes meant that generic drug makers should not be held accountable for failure to warn against any risks pertaining to the drug.
As a result, consumers who are taking a brand name drug can have legal recourse if they are injured by a drug while those taking a generic drug normally do not.
FDA’s top pharmaceuticals official, Dr. Janet Woodcock, spoke at a hearing before a U.S. House of Representatives health subcommittee, stating the this move is needed to “create parity” between branded and generic drug makers regarding the label changing.
The generic drug industry is petitioning aggressively against the proposal.
Ralph Neas, president of the Generic Pharmaceutical Association told the committee, “The proposed rule would expose generic drug manufacturers to substantial new liability costs and would require them to adjust prices to stay in business, withdraw products, or decline to launch new affordable versions of brand medicines.”
“The goal is to make sure the whole system is searching for safety problems and updating labels when they are found,” said Woodcock.
Those who are in favor of this rule say that generic drug makers will not be taking on any more liability than they did before the Supreme Court ruling three years ago.
Allison Zieve, general counsel at the drug safety watchdog Public Citizen, said, “With Greater ability to make prompt safety updates, the proposed rule should help avoid liability….”
She also stated, that “The rule will help prevent injuries from occurring in the first place.”