Bill Introduced to Congress Seeks to Allow Generics to Make Label Changes
Democrats have introduced a bill in both the Senate and House of Representatives that seeks to allow generic drug makers to change product labeling to reflect safety information the same way brand-name drugs are now allowed to alter their labels.
Current laws require that a generic drug label, such as that used to explain generic Reglan side effects, match exactly those included with the brand-name drug. In a 2011 Supreme Court decision, this federal law was ruled to preempt any state laws requiring products to warn of serious side effects. That left many patients who had taken generic Reglan and suffered a serious injury, like Reglan tardive dyskinesia, with no legal recourse to recover damages. Legislators are hoping to change that.
No legal recourse for Reglan tardive dyskinesia
Patients taking the generic form of the heartburn drug Reglan currently have few options when it comes to litigation. Those who filed Reglan lawsuits against generic manufacturers last year ended up with nothing, as the courts ruled that generics cannot be held liable as long as their product labels match exactly those of the brand-name drug. In fact, even if a generic manufacturer wanted to update their labels to reflect new information concerning side effects, they would be unable to under current laws.
Meanwhile, many patients who took Reglan, particularly those who took it for long periods of time, suffered from a serious movement disorder called Reglan tardive dyskinesia. Reglan lawsuits attempted to hold generic manufacturers responsible for failing to adequately warn of the risks, but so far, none have been able to get past the preemption ruling. This has left many patients essentially unprotected when it comes to using generic drugs.
New bill to address discrepancy in generic side effects labels
On April 18, 2012, Senate Judiciary Committee Chairman Patrick Leahy (D-Vt.) introduced the “Patient Safety and Generic Labeling Improvement Act,” which will allow generic drug manufacturers to change their drug labels and provide up-to-date warnings to physicians and the public. Senator Leahy presented the bill to the Senate, and Representatives Bruce Braley (D-Iowa) and Chris Van Hollen (D-Md.) presented it in the U.S. House of Representatives.
“If a consumer takes the brand-name version of the drug,” Leahy said, “she can sue the manufacturer for inadequate warnings. If the pharmacy happens to give her the generic version, she will not be able to seek compensation for her injuries.” Generic companies oppose the act, saying it would result in different drug companies producing different warning information about the same drugs, resulting only in more confusion for patients.
Meanwhile, the consumer advocacy group Public Citizen has asked the FDA to take similar action to allow generics to make label changes, but the agency so far has said only that it needs more time to decide on the issue.