A new rule has been proposed by the Food and Drug Administration that would allow generic drug companies to update their own warning labels on the drugs they manufacture. The rule would also force all manufacturers of the same drug to update their warning labels should one company in the group get approval from the FDA to make a change to their label.
Only brand-name drug companies currently have the ability to autonomously update their warning labels without approval from the FDA. Generic drug companies have been required to copy brand-name warning labels of equivalent products and have not been able to update the labels without the FDA’s approval.
Under the new rule, generic drug manufacturers will no longer have to wait for the brand-name manufacturer to update its warning label, and can petition to the FDA if a warning label needs to be modified, possibly allowing consumers to be aware of any new, dangerous risks before it is too late.
However, giving brand-name and generic drug companies the power to update and change their drugs’ warning labels could be an opportunity for the manufacturers to disclose potentially dangerous risks associated with their products. Brand-name companies, such as Tylenol, an over-the-counter drug that has been on the market for decades, have been notorious for concealing the risks associated with their products to capitalize on market share. Tylenol carries an increased risk of acute liver failure and the drug’s manufacturer failed to warn of those risks, which resulted in several deaths from the use of the drug.
“Big Pharma companies will take advantage of any opportunity they get to maximize profit, even if it means potentially sacrificing consumer health by failing to disclose dangerous risks associated with their products,” said Mike Papantonio, host of Ring of Fire.
The Generic Pharmaceutical Association warns that the FDA should be the sole decision-maker when it comes to approving any updates to pharmaceutical drug labels.
“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,” president of the Generic Pharmaceutical Association, Ralph Neas, told USA Today.
Krysta Loera is a writer and researcher for Ring of Fire.