Proposed FDA Rule Strips Court Protection From Generic Drugs

A new rule proposed by federal drug regulators could address the current problem with generic drug warnings, which allow manufacturers of generic medications to escape liability even when they sell medications that contain known side effects that are not adequately disclosed on the warning label.  

Currently, federal regulations require that generic drug manufacturers provide the exact same label warnings as the brand name version of the drug they are copying. This applies even when the brand name version is no longer sold and when the generic manufacturer learns about new side effects that may cause consumers to suffer serious or even life-threatening injuries.

Following a 2011 Supreme Court ruling in Pliva v. Mensing, generic drug makers have used this limitation on their ability to update warning labels as a defense in product liability lawsuits brought by consumers who suffer injuries as a result of problems associated with the medication that were not disclosed by the manufacturer.

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Known as federal pre-emption, generic drug makers have successfully had thousands of lawsuits dismissed arguing that state-law failure to warn lawsuits are pre-empted by the current federal regulations that require they carry the same warnings as the brand name equivalents.

However, on Wednesday, the FDA proposed a new rule, which would allow generic drug manufacturers to update their labels with new warnings, even when the brand name is no longer on the market.

The proposed rule changes regulations for new drug applications, abbreviated new drug applications and biologics license applications. It lays out the means and requirements for generic drug manufacturers to update the labels on their drugs.

Proposed Rule Follows Another Blow to Consumer Protection

The proposal comes just days after the Supreme Court stripped a $21 million court victory from a woman who was blinded and burned across two-thirds of her body by generic sulindac. The case involved a lawsuit filed by Karen Bartlett against Mutual Pharmaceutical, the manufacturer of the generic version of Clinoril.

Bartlett had argued that Mutual Pharmaceutical should not be protected from her lawsuit, because the medication was defectively designed and the drug maker could have chosen not to sell the medication at all. Although a lower appeals court allowed the verdict to stand, the U.S. Supreme Court overturned the verdict and further narrowed the recourses available to people injured by generic drugs.

As in the 2011 ruling in Pliva v. Mensing, the ruling was split down ideological lines, with the majority conservative judges pushing for protection of manufacturers, and liberal judges dissenting in favor of protecting consumers.

Even before the latest ruling, a number of lawmakers and consumer protection groups called for the FDA to step up and author new regulations that would resolve the problem.

In August 2011, the prominent consumer advocacy group Public Citizen filed a petition with the FDA calling for the agency to amend the federal regulations that limit generic drug makers’ ability to update warning labels. The group indicated that the outdated regulations prevent consumers from learning about many known risks associated with generic drugs and has become a shield for pharmaceutical companies against product liability lawsuits.


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