Current U.S. Food and Drug Administration (FDA) regulations do not require generic drug companies to update their warning labels to reflect potential dangers found by ongoing pharmaceutical research, reported ThinkProgress.
“It is a regrettably common occurrence that new products on the market contain hidden dangers that the public is unaware of,” commented Megan McBride an attorney with the Levin, Papantonio law firm who practices in the areas of personal injury and product liability litigation.
Responding to the FDA’s weak regulations concerning warning labels on generic drugs, a group of patients who’ve been harmed by under-labeled drugs will attend a public hearing to request that the FDA revamp its generic drug regulation. As the rules currently stand, generic drug makers are required to update their warning labels only at the specific request of the FDA. Otherwise, warning labels may remain outdated.
For instance, women who take the generic form of the birth control pill Yaz are at an increased risk of developing blood clots. Yaz contains the hormone drospirenone, which has been linked to causing blood clots.
ThinkProgress noted that Bayer Health Pharmaceuticals paid out over $1 billion to U.S. plaintiffs who filed lawsuits claiming that name-brand Yaz caused deadly blood clots. However, because generic drugs aren’t held to the same regulatory standard as name brand drugs, those harmed by generic drugs cannot take legal action.
Generic drug manufacturers are protected from any litigation that would otherwise be pursued against a maker of name-brand drugs. Generic drugs make up approximately 80 percent of the American pharmaceutical market, leaving a massive potential for patients to be harmed by dangerous drugs with no option for legal recourse.
“[Generic drug makers] no longer have an incentive to monitor the safety of their products and make sure warnings are up to date,” said Dr. Michael Carome, health research group of consumer advocacy group Public Citizen. “That ultimately presents a significant safety threat to patients.”
The Generic Pharmaceutical Association (GPhA) is opposed to any regulatory changes that would require generic drug makers to continuously update their warning labels. The GPhA found that litigation that could result from the rule change would cost the generic drug industry approximately $4 billion a year.
The central goal of any drug company is profit, even if it comes at the expense of patients’ lives. Will the FDA listen to this group of patients and consumer advocates? It should in order to protect the lives of millions of patients.