FDA Delays Generic Drug Label Warning Rule Again

Despite reported plans by federal regulators to issue new rules on generic drug safety labels, which would allow manufacturers to update warnings about new health risks, it appears that the proposed rule has been delayed yet again. 

For four years, the FDA has left proposed rules in limbo, which are designed to close a loophole that allows generic drugs to carry outdated label warnings that fail to disclose known risks, without exposing the pharmaceutical company to liability through failure to warn lawsuits. The agency indicated it was planning to introduce those rules in April, following several delays throughout the years. However, an Agency Rule List released last month by the Office of Management and Budget (OMB) yet again does not have the proposed rule on the list for at least the next 12 months.

Currently, generic drug makers are prohibited from independently updating the warnings provided with their medications, even when they are aware that the label fails to provide accurate information about the potential side effects. Existing regulations require the copycat drugs to carry the same label information as the brand-name version of the medication. However, this has allowed generic drug makers to continue to profit off of medications that they know contain serious side effects of which doctors and patients may be unaware.

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Generic drug makers have used this prior limitation of warning label updates as a shield against product liability lawsuits filed by consumers who suffered injuries while using the medications, arguing that such claims are barred since 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.

In November 2013, the FDA announced that it would implement new generic drug labeling rules, which would allow manufacturers of generic medications to update warning labels to add new information discovered about potentially dangerous side effects not disclosed by the manufacturers of the brand name drugs being copied.

The rules were supposed to be finalized in December 2015, but after that date passed, the FDA indicated that implementation of the generic drug labeling rules will be delayed until at least July 2016. That date passed with no rule, and again delayed the rule until April 2017, which has also passed.

With no sign of the rule on the OMB’s agency rule list, it is unclear when, if ever, the rule will be put forward to close what many consider a loophole that works as a legal shield for generic drug makers who fail to warn the medical community and patients about dangerous drug risks.


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