July 3 The U.S. Food and Drug Administration
plans to issue a proposed rule that would allow generic drug
companies to update prescribing information for their products
to reflect new safety information.
Currently, generic manufacturers, in contrast to branded
drugmakers, are not allowed to update their drug labels even if
they learn of a potential safety issue that is not included in
the existing label.
The FDA's plan, described on the website of the Office of
Management and Budget on Wednesday, would require all
manufacturers of the same drug to carry consistent labeling
revisions after the FDA had approved a revision by one company.
"Many potential hazards are not discovered until years after
drugs have been on the market," said Dr. Sidney Wolfe, founder
of Public Citizen's Health Research Group.
Wolfe's group about two years ago filed a citizen petition
with the FDA asking that it to revise its labeling rules to
establish labeling parity between generic and brand-name drug
"The proposed rule is a classic example of harm reduction,"
he said. "When finalized after public comments, it will provide
added protection to the tens of millions of people who regularly
use generic drugs."
The proposed rule comes shortly after the U.S. Supreme Court
ruled that generic drugmakers cannot be sued under state law for
adverse reactions to their products. The court ruled that a
state's law cannot run against federal laws on prescription
medications whose design has been approved by the FDA.
A Supreme Court ruling in 2011 found that pharmaceutical
companies that make branded drugs are liable for inadequacies in
safety warnings on a drug's label, but not the makers of generic
copies. Federal law requires generic drugs to have the same
design and warning labels as their branded equivalents.