The Food and Drug Administration announced Wednesday that generic drug companies now have permission to makes changes or update safety information on their products if information about potential risk is discovered.
According to CBS News, the new rule was announced on the Office of Management and Budget website. The rule also stated that manufacturers of the same drug are expected to change their warning labels as long as the FDA approves changes to one manufacturer.
"We are extremely pleased to see the Food and Drug Administration 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 to CBS News. "When finalized, the revisions will fill a regulatory gap that poses a risk to patient safety."
According to USA Today, the new rule comes at a great time. The FDA has experienced years of petitioning from Public Citizen, a non-profit consumer rights advocacy group. In recent reports, Public Citizen asked that the FDA make it easier for generic drug makers to change their safety labels.
In 2011, in a 5-4 ruling, the U.S. Supreme Court decided that generic drug makers cannot be sued if patients experienced any harmful side effects from drugs approved by the FDA. The court ruled that a maker cannot be sued for inadequate labeling of a generic drug.
But not all trade associations are on board with the new rules. The Generic Pharmaceutical Association believes warning labels should be left to the FDA.
"Decisions on safety and efficacy of prescription drugs should rest in the hands of the FDA, the only body with scientific knowledge, regulatory experience and complete data that is needed to make these decisions," Ralph Neas, president of the Generic Pharmaceutical Association, told USA Today.
Currently, only brand-name companies can update their safety information without FDA approval if they find there is a potential issue. Generic companies are not allowed to add or change safety labels, unless it is ordered by the FDA or a brand-name manufacturer has already done so.
