FDA May Change Warning Regs For Generic Labels

Last year, the US Supreme Court ruled generic drugmakers are not required to strengthen labeling even when alerted to side effects. The decision came in response to lawsuits by two women who claimed changes could have been made under state law and without FDA approval. They argued generic drugmakers would create uncertainty about safety if they are not held liable under state laws and update labeling in the face of evidence of serious side effects. Under current FDA regulations, however, generic drugmakers cannot update labeling, even if they become aware of a potential risk not mentioned in the labeling. Brand-name drugmakers, though, can update warnings and precautions on product labeling before obtaining FDA approval. In other words, the generic drugmaker is required only to match its labeling to brand-name labeling. As a result, the FDA was petitioned to revise its regulations so generic drugmakers can update product labeling to warn patients about risks associated with their drugs. And now, there is an indication the agency may do so. How do we know? A footnote in a friend-of-the-court brief that the US Department of Justice filed last month in a somewhat related case concerning the responsbiilty of generic drugmakers and design defects. This is what the footnotes states: “This office has been informed that FDA is considering a regulatory change that would allow generic manufacturers, like brand-name manufacturers, to change their labeling in appropriate circumstances...
Source: Pharmalot - Category: Pharma Commentators Authors: Tags: Uncategorized FDA Pliva Preemption Prescription Drug Lableling Takeda Pharmaceuticals Source Type: blogs