The US Food and Drug Administration has announced plans to speed up the dissemination of safety information updates for generic drugs, by requiring their makers to use the same process as branded firms to update such information in the product labelling.
Under the proposal, generics firms will be able to independently update product labelling with newly-acquired safety information before the FDA’s review of the change. as branded drugmakers currently do - and be required to inform the branded firm of the change.
“More than 80% of prescriptions filled in the US are for generics, so we want to make sure that generic drug companies actively participate with the FDA to ensure that product safety information is accurate and up to date,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER).
“Faster safety updates and easier access to this information should be a win-win for all involved,” she added.
The proposal is welcomed by consumer groups including Public Citizen, which says it would “close a regulatory gap that poses a risk to patient safety.”
However, industry group the Generic Pharmaceutical Association (GPhA) says it is “very concerned that multiple versions of critical safety information would lead to unnecessary confusion and uncertainty for prescribers and other healthcare professionals, with harmful consequences for patient.”
Identical labels underscore a critical point – that once generics pass through extensive FDA review, they are proven scientifically equal to the brand medicine in terms of safety, efficacy and quality, says GPhA. It also points out that currently, the law requires a generic to have exactly the same label as the branded originator and the generics firm cannot make changes to a label without FDA approval – a point “repeatedly” held by the Supreme Court.
“Therefore, the agency’s authority to enact a rule that differs from the federal law is unclear,” says GPhA.
And the US Chamber of Commerce warns that the proposal “writes a prescription for mega lawsuits against generic drugmakers by plaintiffs’ lawyers alleging that generic labels are somehow inadequate.”
“It is unfortunate that the FDA is considering a change that could drive up the cost of generic drugs, perhaps by billions of dollars,” said Lisa Rickard, president of the Chamber’s Institute for Legal Reform (ILR).
The FDA has published the proposal in the Federal Register and is seeking public comment.