Last week, the US Food and Drug Administration (FDA) again delayed making a decision about whether generic drug makers should be required to keep their medication labels updated about newly discovered risks. The delay marked the third time that the FDA has postponed making a decision about generic labeling. The final ruling date has been pushed out to April 2017.
Supreme Court Creates Generic Drug Legal Loophole
In 2011, the Supreme Court ruled in Pliva v. Mensing, that makers of generic drugs cannot be held liable for failing to warn patients of risks associated with taking their drugs. The logic behind the ruling is that generic drug manufacturers currently have no control over the content of the medication labels.
FDA Admits Lack of Generic Drug Safety
Following the top court’s ruling, in 2013, the FDA announced that it would consider changing its rules so that generics would be subject to the same labeling requirements as branded drugs.
Current law states that branded drug manufacturers must change their labeling when important new information is discovered about a drug. The federal agency acknowledged that a rule change which brought parity of responsibility to generic drugmakers would improve drug safety for patients.
Patients Have No Legal Recourse for Generic Drug Risks
Without clarification or additional rules enacted by the FDA, patients who have been harmed due to inaccurate medication labels on generic drugs are left with no legal recourse. Thus, drug makers are effectively bulletproof, with little accountability available for patients within the current legal landscape.
Drug Makers Don’t Want Responsibility
Weighing in against changing the existing rules is Generic Pharmaceutical Association (GphA), aided by their branded drug counterparts in the Pharmaceutical Research and Manufacturers of America (PhRMA). These groups recommend an alternative approach called an Expedited Agency Review, which essentially shifts the burden of labeling approval back to the FDA. For its part, the FDA says it doesn’t have the staff to enact such a review of all generic medication labels on the market.
In announcing the new delay last week, the FDA left itself wiggle room, saying that the projected ruling date “may be adjusted to reflect ongoing work on specific rules.”
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