FDA Proposed Generic Drug Rules Could Solve Preemption Problem

New rules have been proposed by the FDA that are designed to allow generic drug manufacturers to change warning labels for medications they sell. However, the new regulations could also end up restoring consumers’ ability to pursue product liability lawsuits against generic drug makers when inadequate warnings are provided about known risks associated with their medications.  

The FDA will publish proposed labeling rule changes for generic drug manufacturers (PDF) in the Federal Register on November 13.

The agency indicates that the new regulations will allow generic drug makers to use the same process as brand name drug manufacturers to update label warnings and safety information for medications they manufacturer and sell.

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Currently, generic drugs must contain the same warning label that is provided on the brand name version of the medication, even if the manufacturer knows or reasonably should know that the information provided for consumers and the medical community is inadequate.

Generic drug makers have used this prior requirement as a shield in product liability lawsuits filed by consumers who suffered injuries while using their medications, arguing that it is impossible to comply with the federal regulations and state-law failure to warn claims.

Known as federal preemption, the U.S. Supreme Court upheld this defense in the controversial 2011 ruling in Pliva v. Mensing, which has essentially granted generic drug makers immunity in failure-to-warn lawsuits over injuries caused by medications they manufacture and sell. Even when plaintiffs alleged that a generic manufacturer was aware that the labels on the brand-name version of the medication was inadequate, courts have granted motions to dismiss.

The proposed rule by the FDA will likely change this and largely negate the preemption argument by generic drug makers. Under the new regulations, generic drug makers will be able to independently update product labeling with new safety information before the brand name drug is updated or if the brand name drug is no longer sold. Manufacturers would be able to inform the FDA and the brand name manufacturer of the changes, and the FDA would review the new safety information.

With that option open to them, Courts may find that generic drug manufacturers are no longer insulated from liability when they fail to disclose potential side effects that are discovered, multiple experts say.

“This proposal will help ensure that health care professionals and consumers have access to the latest safety information for the medications they use,” FDA Center for Drug Evaluation and Research Director Janet Woodcock, M.D., said in a press release. “More than 80 percent of prescriptions filled in the U.S. are for generics, so we want to make sure that generic drug companies actively participate with the FDA to ensure that product safety information is accurate and up to date.”

The FDA drafted the rule this summer and officially proposed it on November 8. The FDA is seeking public comment on the rule before its implementation.

Calls For Action Followed Supreme Court Ruling

In recent years, as a number of individuals injured following use of generic medications were left without a recourse for failure-to-warn, a number of lawmakers and consumer protection groups have called for the FDA to step up and author new regulations that would resolve the pre-emption 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.

The rule is likely to face resistance from generic drug manufacturers, who want to keep their immunity to failure-to-warn lawsuits. Some have suggested that the FDA is overstepping its authority by altering drug safety rules passed into law by Congress.


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