Leahy Bill would boost generic drug safety in USA, says consumer group

A bill giving generic drug manufacturers in the USA the authority to revise labeling for their products when they become aware of risks that are not adequately disclosed would fill a hazardous hole in drug regulation, consumer advocacy group Public Citizen said in a letter sent to Senate Judiciary Committee Chairman Patrick Leahy, who introduced the Patient Safety and Generic Labeling Improvement Act this week.

The generic drug market has grown exponentially in the past 25 years; generic drugs now constitute a majority of the prescription drugs sold in the USA. The regulatory system, however, has not adjusted to the marketplace. Leahy’s bill would fix that, Public Citizen points out.

The proposal is consistent with the citizen petition that Public Citizen submitted to the Food and Drug Administration in August 2011. The petition urged the FDA to update its drug regulations to allow generic drug manufacturers to revise their product labeling to warn patients about risks associated with their drugs. The FDA has not responded substantively to the petition.