FDA plans to revise drug labeling regulations by September

The US Food and Drug Administration says it plans to issue a proposed rule to revise FDA regulations about prescription drug labeling by September, a move that could open the generic drug makers up to liability if their drugs injure patients.

According to a description on the Office of Management and Budget’s (OMB) web site, the revised rule would create parity between brand-name pharma companies and generic drug manufacturers with respect to revising drug labeling to provide information about newly discovered risks.

The proposed rule comes shortly after the US Supreme Court ruled that generic drugmakers cannot be sued under state law for adverse reactions to their products (The Pharma Letter June 15). The court ruled that a state's law cannot run against federal laws on prescription medications whose design has been approved by the FDA.