Withdrawal of Proposed Rule on Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products

The US Food and Drug Administration (FDA) withdrew a proposed rule on label changes for generic drugs after concerns were raised by commenters. The FDA had proposed a new federal rule in 2013 that would have allowed people to hold generic-drug companies legally liable for the side effects of medicines. FDA's action by the agency withdrew the proposed rule, and keeps generic companies largely impervious to lawsuits. At issue in the complex matter is whether generic-drug companies are allowed, like brand-name drug companies, to change their drug labels to reflect new safety concerns. Currently, generic-drug companies must follow the labels written by the brand-name companies.

The otherwise arcane issue of drug labels became a major practical issue beginning with a 2011 Supreme Court decision that an injured person can’t bring a claim against generic makers over failure to warn about a drug’s adverse side effects. The court reasoned that generic companies—unlike brand-name companies—shouldn’t be liable because they have no authority to modify their labels.

In 2013, the FDA proposed the rule that would have allowed generic makers to change labels, a step the generic industry largely opposed. Thursday the agency dropped its plans to pursue the new rule.

FDA Commissioner Scott Gottlieb and the FDA’s drug-center director Janet Woodcock said in a statement, “We heard from manufacturers that they believed this change would have imposed on them significant new burdens and liabilities” and that the measure “might have raised the price of generic drugs to patients.”

for more details: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628339.htm