Expert Says Safety Labeling Guidance Debunks RLD Theory; PA Court Disagrees

The FDA’s final guidance on safety labeling changes, issued Tuesday, clears up any ambiguity about whether drugmakers can make changes to a generic drug’s label if that drug is designated as a reference listed drug (RLD). According to industry experts, the guidance prohibits such changes.

James Beck, a lawyer in the Philadelphia office of Reed Smith, told DID Wednesday the guidance negates the controversial RLD theory of liability and a Monday ruling by the Pennsylvania Superior Court upholding the much-debated hypothesis (DID, March 20, 2012).

(Drug Industry Daily; read more here; subscription required)