House and Senate Introduce Bill Concerning Labeling For Generic Drug Manufacturers
Democrats in the House and Senate introduced bills that would permit generic drug manufacturers the ability to revise the warning labels for generic drugs--in effect making the regulations applicable to brand name drugs applicable to generics. However, it appears that both the bills in the House and Senate bills died in committee.
The bills were introduced in response to the Supreme Court's decision in Pliva v. Mensing about which we have previously written (here and here). In Mensing, the Supreme Court held that federal law preventing generic drug manufacturers from independently changing their generic drugs' warning label pre-empted state law failure-to-warn claims. In essense, according to the Court, it was "impossible" for generic drug manufacturers to comply with both state and federal law. As we previously stated:
Thus, according to the Court, generic drug manufacturers are caught between a proverbial “rock and a hard place”: because state law failure-to-warn claims impose a duty on generic drug manufacturers to provide a “safer label” than required by federal regulations, if the manufacturers had independently changed their labels to satisfy their state-law duty, they would have violated federal law which requires generic drug labels be the same at all times as the corresponding brand name drug labels. “Thus, it was impossible for the Manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same.”
The bills would have changed this dynamic by allowing generic drug manufacturers the ability to propose changes to the warnings for their generic drugs in response to safety concerns.
Interestingly, 41 state attorney generals signed a letter in support of the bills, stating:
Consumers whose prescriptions happen to be filled with the brand-name version of a drug are protected by state law from inadequate warnings, but consumers whose pharmacists fill their prescriptions with the generic versions are now denied this protection. Congress can readily cure this problem by amending federal law.
Despite the support of the attorney generals, the bills appear to be going nowhere. Consequently, for now, generic drug manufacturers remain largely immune from product liability lawsuits, particularly those based on state law failure-to-warn claims.
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