FDA is holding off on the release of a controversial rule that would allow generic drug makers to use the same process as brand-name drugs in updating safety information on product labels. A final ruling the FDA had previously announced would appear next month will now be published in the fall of 2015, The Wall Street Journal reports.
Under the proposed rule, generic drugmakers would be allowed to update safety labels independently to warn of newly discovered risks without waiting for FDA approval, just as brand drugs do. Patient groups have petitioned in favor of the rule, claiming it would allow more timely warnings of emerging risks. Yet the change is strongly opposed by the generic industry, which fears it will be held liable if it doesn’t add risk information to labels and patients are harmed.
The agency proposed the rule after a 2011 U.S. Supreme Court decision holding that federal law does not permit generic drugmakers to make such changes independently. The agency’s proposal would change a law in effect since 1984 that requires generic labeling to be the same as the approved labeling for the copied brand drug.