FDA Delays Issuing New Generic Drug Label Rule

A new proposed rule that will allow generic drug makers to update their own safety warnings on labels has been delayed until the fall of 2015. The new rule has been labeled as “controversial” because it would give the makers of generic drugs the ability independently update safety warnings. This is currently something that only brand-name drug makers are allowed to do prior to receiving permission from the United States Food and Drug Administration (FDA).

An article that was recently published on the Wall Street Journal’s website makes the following comments:

  • There are concerns that generic drug labeling might be insufficient to warn patients about the risks associated with certain generic medications
  • Generic drug manufacturers are not required to run tests that prove their medications are exactly the same as the brand-name variety

When it comes to brand-name and generic drugs, there are many concerns about warning labels. The complexity and controversy surrounding this particular issue is the reason for the FDA’s delay in finalizing the new rule.

At Golomb Legal, our lawyers are highly experienced in helping pharmaceutical injury victims. We know the complex laws that govern these cases, and we have the vast resources necessary to battle large pharmaceutical companies in court to recover the compensation you deserve.

If you’ve been injured due to the consumption of a generic drug, please contact Golomb Legal today to schedule a free consultation. We serve clients nationwide from our offices in Philadelphia.