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FDA No Longer Pursuing Rule Update to Require Generic Drug Makers To Warn Of Known Side Effects

A recent decision by federal regulators will permit generic drug makers to continue taking advantage of a controversial loop hole in drug labeling laws, which allows pharmaceutical companies to escape liability for failing to warn about known side effects associated with medications they sell. 

Despite years of work, and calls from both inside and outside of the agency to ensure accurate and up-to-date warnings are provided to consumers by generic drug manufacturers, the FDA posted a notice last week about the withdrawal of a proposed rule involving label changes for approved drugs.

The FDA originally proposed the rule in November 2013, which would have allowed generic drug manufacturers to independently update and distribute new safety information about medications they sell, which is currently only something that branded drug makers can do.

In a statement issued on Thursday, FDA Commissioner Scott Gottlieb and Janet Woodcock, director of the Center for Drug Evaluation and Research, indicated that the proposed rule is being withdrawn, and that the agency will take steps to update labels on certain generic drugs with modern safety and efficacy information.

The decision will allow drug makers to continue using the existing rules as a “shield” against generic drug lawsuits over failure to warn about dangerous side effects, even when there is evidence that the pharmaceutical companies were aware the existing labels are inadequate.

The proposed rule was designed to allow generic drug manufacturers to change their products labels to reflect newly discovered dangers to consumers, and close a dangerous gap in federal regulations that may occur when new side effects are discovered after an older drug is no longer sold as a brand-name product.

Currently, generic drug manufacturers must place the same label warnings on drugs that the brand-name product carried, even if new problems are found that could put patients at risk. In a 2011 U.S. Supreme Court ruling known as Pliva v. Mensing, the high court determined that this effectively shielded generic drug manufacturers from failure to warn lawsuits.

That means that even if a generic drug manufacturer learns their products can kill, they are not required to warn the public or the medical community if the problem was discovered after the brand-name drug was no longer on the market.

For years, drug safety experts, consumer watchdog groups and lawmakers have urged the FDA to fill this loophole. However, after considering comments on the action, the agency is now torpedoing that effort, saying that would be too much trouble for the generics manufacturers to be required to warn consumers of potentially deadly drug side effects.

“This rule, if implemented, would have allowed generic manufacturers to independently update their drug labels with new information,” an FDA press release from Gottlieb and Woodcock states. “We heard from manufacturers that they believed this change would have imposed on them significant new burdens and liabilities.”

The announcement indicates the FDA feared the new labels would have raised generic drug prices and caused consumer confusion. The agency also claims that it wants to avoid unintended consequences, like multiple generic versions of the same drug having different warning labels.

Gottlieb and Woodcock indicate that there are already requirements in place for generic drug manufacturers to provide updates to product labels. It is then up to the FDA to determine whether the change is appropriate. However, previous administrations and FDA regulatory analysts have said this approach does not work.

The FDA officials note they are advancing other initiatives to update drug product labels on certain generic cancer drugs. However, the concerns about updated labels has ranged across a wide variety of medications.

Since the Supreme Court ruling, thousands of lawsuits filed against the manufacturers of generic drugs have been dismissed, even though those medications have caused permanent and devastating injuries for consumers who were never warned about known risks associated with the medications.

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