Consumer Group Warns FDA Against Delaying Generic Rx Label Rules

On Thursday, consumer advocacy group Public Citizen said FDA, under pressure from drugmakers, might be considering delaying a proposal to revise product labeling requirements for generic drugmakers, Roll Call's "Healthopolis" reports (Christensen, "Healthopolis," Roll Call, 2/27).

Background

In 2013, FDA issued a draft rule that would require generic drugmakers to update their product labels without FDA approval if they receive new information about the safety of those products. The regulation would bring the drugmakers in line with their brand-name counterparts and make them liable for lawsuits about consumer safety.

FDA in December 2014 said it expects to issue the final rule later this year. FDA recently reopened the comment period for the proposed rule and is holding a public meeting on the proposal on March 27 (Gustin, CQ HealthBeat, 2/26).

Public Citizen Comments

Public Citizen, which petitioned for the labeling changes in 2011, said FDA "is allowing industry pressure to delay and possibly endanger a significant patient safety rule it proposed in 2013 in response to a Public Citizen petition" (Public Citizen release, 2/26).

Public Citizen said, "At issue is whether generic drug manufacturers have any responsibility for providing doctors and patients with new-found information about risks posed by the companies' products." According to the group, delaying the rule could jeopardize patient safety (CQ HealthBeat, 2/26).

The group said, "The agency should resist pressure from the pharmaceutical industry, which is putting profit above patient safety, and instead finalize a rule that will protect patients" (Public Citizen release, 2/26).