Consumer advocates are applauding the FDA’s recent announcement to allow generic drug manufacturers to make changes to safety labels.
Currently, brand name manufacturers are allowed to change their labels, without FDA approval, if the company becomes aware of new risks associated with the drug after some time on the market. Generic drug companies are only allowed to change product safety labeling if it were ordered to do so by the FDA or if its brand name equivalent made a similar change. However, there are 434 generic drugs on the market with no brand name equivalent, according to the consumer advocacy group, Public Citizen.
Consumer watchdog groups and medical experts have been petitioning for years for a revision of FDA rules because generic drugs have become so popular in the last few decades. Over 80% of prescriptions last year were filled with generic drugs. Dr. Sydney Wolfe of Public Citizen’s health research group says, “The proposed rule…will provide added protection to the tens of millions of people who regularly use generic drugs.”
Multiple lawsuits against generic drug manufacturers have been dismissed since 2011, when the Supreme Court ruled that inadequate labeling of a generic drug was not cause for a lawsuit against the maker. In contrast, a name brand drug is liable for inadequate safety labels. Experts say this causes a “regulatory gap” between generic and name brand product safety.
Michael Johnson, a lawyer who represented one of the patients who sued generic drug companies in the 2011 Supreme Court case, Pliva v. Mensing, says that the proposition “is a first step toward acknowledging that there is a problem with the current system. It doesn’t make sense to have one set of rules for the name brand and another set for the generics.”
The FDA says that the proposed change would create equality between generic and name brand manufacturers in respect to updating their drug safety labels. Because the proposition would allow generic manufacturers to change their labels if they became aware of safety issues, it could also make them liable for potential harm to patients.
In the past, generic drug companies have been opposed to such a change, saying that they prefer to leave decisions about drug safety in the hands of the FDA. The FDA is expected to publish a proposed rule by September.
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