Present Food and Drug Administration (FDA) regulations prohibit generic drug manufacturers from updating a product’s safety labeling quickly. This creates a problematic safety gap, whereby the public is left unaware of potential health risks from the generic drugs they take.
Nearly two years ago, watchdog group Public Citizen submitted a petition to the FDA calling for a change in regulations regarding generic drug labeling. After an FDA announcement on July 3rd that the regulation may soon change, it appears that Public Citizen’s plea has been heard.
The new proposed rule would allow generic drug makers to make the safety information publicly available while the FDA takes its time to review it.
Dr. Sidney Wolfe, founder of the Public Citizen’s Health Research Group, said in a statement: “When finalized, the revisions will fill a regulatory gap that poses a risk to patient safety.”
In a report published by Public Citizen last month, the group announced that after reviewing a period from January 2008 to March 2013, they found 53 drugs “for which a black-box warning calling attention to serious or life-threatening risks was added after generic market entry.”
The report shined a light on serious safety hazards connected to drugs that are often not discovered until a product, whether prescription or generic, has been used for several years.
In effect, the report showed that the amount of time a drug has been on the market does not necessarily correlate to its safety.
Brand-name manufacturers are currently allowed to give public safety information updates before the FDA has approved the change, and those changes put forth from the prescription drug can trickle down to the generic drug.
The problem, according to Public Citizen, is that competition from generic drugs – with their lower prices – usually causes the brand-name manufacturer to stop producing the prescription drug. As a result, the brand-name manufacturer becomes an unreliable source for keeping abreast of the latest hazards involved with a drug.
According to the FDA, nearly 8 in 10 prescriptions in the US are filled with generic drugs, so the new proposal to allow generic drug manufacturers to make new safety information available immediately could have a big effect.
Dr. Wolfe was pleased with the FDA’s announcement, and said:
“The proposed rule is a classic example of harm reduction. When finalized after public comments, it will provide added protection to the tens of millions of people who regularly use generic drugs.”
Though the FDA states that it does monitor adverse events reports for generic drugs, the new proposal will make that information obvious to consumers in a more timely fashion.