Two years ago, the US Supreme Court ruling that generic drugmakers are not required to strengthen product labeling, even when alerted to side effects, so long as the same change has not been made to the labeling for the branded medicine. The decision sparked an outcry that product labeling would be insufficient to warn patients about the risks associated with numerous medications.
Now, though, the FDA is following through on reported plans to issue a proposed rule to revise regulations to allow generic drugmakers to update labeling. The rule would update current regulations that prevent generic drugmakers from doing so, even if they become aware of a potential risk not mentioned in labeling. By contrast, brand-name drugmakers can update warnings and precautions on labeling before obtaining FDA approval.
The move by the FDA, which was disclosed on the web site of the Office of Management and Budget and was described as an attempt to “create parity” in the responsibilities required of both brand-name and generic drugmakers. The disclosure, not surprisingly, was hailed by consumer advocates, such as Public Citizen Health Research Group, which had petitioned the FDA to change its regulations.
“Many potential hazards are not discovered until years after drugs have been on the market,” says Public Citizen’s Sidney Wolfe in a statement. “Yet, currently, drug manufacturers can do little to warn doctors and patients about newly discovered information, putting patients at risk. The proposed rule is a classic example of harm reduction. When finalized after public comments, it will provide added protection to the tens of millions of people who regularly use generic drugs.”
The rule “would amend the regulations regarding new drug applications, abbreviated new drug applications and biologics license applications to revise and clarify procedures for changes to the labeling of an approved drug to reflect certain types of newly acquired information in advance of FDA's review of such change,” according to the US Office of Management and Budget (here is the proposed rule).
In the 2011 Supreme Court case, which is known as Pliva v. Mensing, two women had claimed in different lawsuits that generic drugmakers could have made changes to their product labeling under state law and without FDA approval for such changes. They cited an earlier 2009 Supreme Court decision – Wyeth v. Levine – that found FDA regulations do not protect drugmakers from being sued under state law over labeling.
But generic drugmakers countered that they would have been required to provide labeling that is different from what appears on labeling of the brand-name drug, effectively convincing the court that federal law preempts state law. In siding with the drugmakers, a 5-to-4 majority found that it would have been impossible for generic drugmakers to comply with both state law and federal regulations (back story and here is that ruling).
The decision sparked a flurry of legal maneuvering in subsequent cases in which attorneys sought to avoid the preemption argument while hoping to force generic drugmakers to be held liable for harm suffered by consumers, but to no avail (back story). Meanwhile, a pair of bills was introduced in the US House and Sent to allow generic drugmakers to make changes in product labeling (back story).
“The decision creates a troubling inconsistency in the law governing prescription drugs,” Patrick Leahy, a Vermont Democrat who co-sponsored a Senate bill, said at the time. “If a consumer takes the brand-name version of drug, 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."
The same issue was at the heart of another case decided last month by the Supreme Court, which ruled that state lawsuits claiming drugmakers failed to adequately design their medications cannot proceed because these are pre-empted by federal law. The case had the entire pharmaceutical industry on edge because brand-name drugmakers feared the same notion might also be applied to their practices.
In fact, the Obama administration had filed a brief in support of drugmakers over concerns that the entire FDA regulatory review process could be undermined if medicines deemed safe and effective by the agency could later be considered "unreasonably dangerous.”
Now, though, the FDA is following through on reported plans to issue a proposed rule to revise regulations to allow generic drugmakers to update labeling. The rule would update current regulations that prevent generic drugmakers from doing so, even if they become aware of a potential risk not mentioned in labeling. By contrast, brand-name drugmakers can update warnings and precautions on labeling before obtaining FDA approval.
The move by the FDA, which was disclosed on the web site of the Office of Management and Budget and was described as an attempt to “create parity” in the responsibilities required of both brand-name and generic drugmakers. The disclosure, not surprisingly, was hailed by consumer advocates, such as Public Citizen Health Research Group, which had petitioned the FDA to change its regulations.
“Many potential hazards are not discovered until years after drugs have been on the market,” says Public Citizen’s Sidney Wolfe in a statement. “Yet, currently, drug manufacturers can do little to warn doctors and patients about newly discovered information, putting patients at risk. The proposed rule is a classic example of harm reduction. When finalized after public comments, it will provide added protection to the tens of millions of people who regularly use generic drugs.”
The rule “would amend the regulations regarding new drug applications, abbreviated new drug applications and biologics license applications to revise and clarify procedures for changes to the labeling of an approved drug to reflect certain types of newly acquired information in advance of FDA's review of such change,” according to the US Office of Management and Budget (here is the proposed rule).
In the 2011 Supreme Court case, which is known as Pliva v. Mensing, two women had claimed in different lawsuits that generic drugmakers could have made changes to their product labeling under state law and without FDA approval for such changes. They cited an earlier 2009 Supreme Court decision – Wyeth v. Levine – that found FDA regulations do not protect drugmakers from being sued under state law over labeling.
But generic drugmakers countered that they would have been required to provide labeling that is different from what appears on labeling of the brand-name drug, effectively convincing the court that federal law preempts state law. In siding with the drugmakers, a 5-to-4 majority found that it would have been impossible for generic drugmakers to comply with both state law and federal regulations (back story and here is that ruling).
The decision sparked a flurry of legal maneuvering in subsequent cases in which attorneys sought to avoid the preemption argument while hoping to force generic drugmakers to be held liable for harm suffered by consumers, but to no avail (back story). Meanwhile, a pair of bills was introduced in the US House and Sent to allow generic drugmakers to make changes in product labeling (back story).
“The decision creates a troubling inconsistency in the law governing prescription drugs,” Patrick Leahy, a Vermont Democrat who co-sponsored a Senate bill, said at the time. “If a consumer takes the brand-name version of drug, 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."
The same issue was at the heart of another case decided last month by the Supreme Court, which ruled that state lawsuits claiming drugmakers failed to adequately design their medications cannot proceed because these are pre-empted by federal law. The case had the entire pharmaceutical industry on edge because brand-name drugmakers feared the same notion might also be applied to their practices.
In fact, the Obama administration had filed a brief in support of drugmakers over concerns that the entire FDA regulatory review process could be undermined if medicines deemed safe and effective by the agency could later be considered "unreasonably dangerous.”