FDA Pushes Rule on Labeling by Generics to Next Year

With an aim to create parity between brand-name and generic drugs, the FDA was expected to pass a rule next month that would allow generic manufacturers to independently provide safety updates on their labels. The decision has now been pushed back by 9 months.

A controversial new rule for updating generic drug labeling that the FDA was expected to finalize next month will not be published until the fall of 2015, an agency spokeswoman says.

The rule, which the FDA proposed last year, would allow generic drug makers to independently update safety warnings, something that only brand-name drug makers can currently do before receiving FDA permission.

The agency proposed the rule in response to a 2011 U.S. Supreme Court decision that federal law does not permit generic drug makers to make such changes independently and, therefore, they should not be held accountable for a failure to warn against a risk.

The court ruling sparked an outcry that generic labeling would be insufficient to warn patients about the risks associated with numerous medications, especially at a time when 86% of all prescriptions filled are for generic drugs, according to the IMS Institute for Healthcare Informatics.

Complete article on The Wall Street Journal : http://on.wsj.com/1vqiSe2