When brand name prescription drug manufacturers learn that their product has caused harm to a customer, they are required to notify doctors and potential consumers by sending letters or by adding an additional warning to their product label. However, the same rule does not apply to manufacturers of generic drugs.
Currently, brand name drug manufacturers face liabilities under the “failure to warn” legal theory that says if they do not act quickly enough to keep others safe, they are held responsible. Generic drug manufacturers don’t have to worry about that. Instead, generic drug manufacturers are not allowed to change the labels on their products until the brand name equivalent has done the same. Once a brand name manufacturer has developed a new label resulting from potential harm to consumers, the FDA must approve it before it can be put into place.
Does the 2013 Generic Drug Supreme Court Ruling Place Consumers In Danger?
In a case from 2013, the Supreme Court ruled that patients who claim to be harmed or injured by generic drugs cannot file failure-to-warn lawsuits against generic drug manufacturers who use the FDA-mandated labels. This means that generic drug companies are free from legal risk if their product causes any type of harm or injury to consumers.
The FDA is currently in the process of proposing a rule that will allow the makers of generic drugs to update their warning labels once they learn of the risks of their products. The FDA believes this new rule will allow both generic and brand name manufacturers to be held to the same legal obligations, as well as allow generic manufacturers to act ahead of brand names to keep their consumers safe.
If the new proposed rule is adopted without changes, generic drug makers will be required to update their labels and be liable against failure-to-warn lawsuits. The FDA hopes this new rule will cause generic drug makers to be more proactive in finding out when drugs are harming consumers and work to better warn those at risk.
The generic drug market makes up more than 80% of the prescriptions market in the United States. Currently, these manufacturers are opposed to the new rule proposed by the FDA. They believe the current system has worked well for the past thirty years and will continue to do so. Generic manufacturers warn that adopting the proposed rule will cause generic drug costs to increase by up to $4 billion a year and lead to confusion regarding warning labels for the same drugs. Generic drug makers believe the FDA should be the ones who decide whether or not warning labels need to be changed and to notify who needs to make the changes.
Both sides of the House warn of different risks involved with updating the rule. However, when it comes to the FDA, their sole purpose is to keep consumers safe. If a proposed rule aims to help protect consumers both physically and legally, it is the responsibility of the FDA to push for that to become a rule that all drug manufacturers need to follow.