FDA could soon change labeling requirements for generic drug companies

This blog previously discussed the Supreme Court ruling that ruled in favor of generic drug companies, and against a woman who became injured from ingesting certain items. The court said that generic drug companies were not required to alter their custom labels, as those firms must have identical product descriptions as the mainstream companies. Even though patients might have adverse reactions to certain ingredients, the businesses are not liable, as they cannot make alterations to drug labels.

However, the Food and Drug Administration (FDA) could soon change that practice.

A newly proposed rule would allow generic drug companies to adjust their medical labels, even if it means differing from what the brand name organizations use in their product descriptions. The FDA announced that it will hopefully publish a proposal for new regulation by September of this year.

“We are extremely pleased to see that the Food and Drug Administration (FDA) today announced its plan to issue a proposed rule to revise FDA regulations about prescription drug labeling,” Dr. Sidney Wolfe, founder and senior adviser 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.”

Wolfe’s group submitted a citizen’s petition to the FDA in 2011, asking them to make generic drug companies to address any potential dangers they might find in their products. The Research Group explained that of the 4,653 FDA approved drugs with different ingredients, strengths and delivery methods, 1,062 of those products were available only in generic form.

With some customers only having access to generic drugs, it could be extremely beneficial for them to have as much information as possible. As companies keep an eye on federal rulings, having a color label printer in-house will ensure that they can stay up-to-date on all regulations.