FDA to Allow Generic Companies to Alter Drug Labels
AUGUST 05, 2013
The FDA intends to allow generic drug manufacturers to update product safety labels to include new information on potential risks, according to a July 4 report in USA Today.
The FDA announcement, made July 3, follows a Supreme Court ruling that struck down a lawsuit involving adverse effects from a generic medication. The 5-4 ruling follows several similar lawsuits, where the court ruled that generic manufacturers were not liable for product safety label updates after a generic is already on the market.
“When it comes to decisions on safety and approval of prescription medicine, the FDA is best equipped to make judgments that affect patients,” said GPhA President and CEO Ralph G. Neas in a release. “The experts at the FDA alone have the scientific knowledge, regulatory experience, and complete data to make these decisions.”
The FDA announcement also follows years of petitions from consumer advocacy groups requesting easier processes for label safety updates, USA Today noted.
Currently, generic manufacturers can only change product labels if the FDA approves of the changes or if the regulatory agency orders them to make changes.
According to USA Today, GPhA would prefer the labeling changes remain under the jurisdiction of the FDA.
“Decisions on safety and efficacy of prescription drugs should rest in the hands of the FDA, the only body with the scientific knowledge, regulatory experience, and complete data that is needed to make these decisions,” Neas told USA Today.