The Food and Drug Administration announced Monday it will propose
a prescription drug rule that would make labeling about newly discovered risks the
same for generic drug manufacturers as it is for brand-name drug manufacturers.
Under current FDA regulations, generic manufacturers can’t update their
products’ labeling, even if they learn about a potential risk not stated in the
labeling. They must wait until a brand-name manufacturer changes its labeling or
until they’re ordered by the FDA to revise the labeling.
However, brand-name drug manufacturers can update warnings
and precautions before getting FDA approval.
When final, the rule will fill a regulatory gap that poses a
risk to patient safety, said Sidney Wolfe, founder and senior adviser for Public
Citizen, a consumer advocacy organization.
In August 2011, Public Citizen submitted a citizen petition to the
FDA asking it to revise its labeling rules to fill the safety gap.
The FDA’s new rule would require all manufacturers of the same drug to submit
labeling revisions after the FDA has approved a revision by one manufacturer of
the drug.
Many hazards aren’t discovered until years after drugs have been on the market,
as shown in a recent Public
Citizen report.
Generics now make up the majority of all prescriptions
filled.
