The head of the FDA told Congress this week that the agency intends to finally close a loophole that has allowed generic drug manufacturers to continue selling medications that do not include appropriate label information about known health risks.
FDA Commissioner Scott Gottlieb submitted testimony to the Senate Committee on Appropriations on April 24, indicating that the agency can assume more responsibility in helping make sure that generic drugs warning labels contain updated information when the name brand version of the drug is no longer for sale.
Under current rules, 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, and has reduced confidence in generic medicines.
“If the brand drug sponsor has voluntarily withdrawn their marketing application, there’s no sponsor who is responsible for making any necessary label updates that otther generic applicants would follow. The result is that these drug labels get frozen in time,” according to written testimony submitted. “The number of generic drugs that reference discontinued or withdrawn brand drugs essentially comprises about one-fifth of the total number of reference-listed drugs.”
Since many of these generic drugs with a withdrawn reference drug remain very useful, the FDA is working to close this gap and Gottlieb is requesting additional funding from Congress for the agency to do just that. The testimony also called for more reliance on post-market data tools as well as electronic medical records.
Generic Drug Warning Pre-emption
Many consumer advocates have pushed for the FDA to remove the limitation on generic drug makers updating the warning labels independently, allowing the pharmaceutical companies to be subject to the same requirement to add new safety information when it becomes available.
In recent years, generic drug makers have used this prior limitation on their ability to make label changes as a shield against product liability lawsuits filed by consumers who suffered injuries while using the medications, arguing that even when there is evidence that they knew the labels were insufficient, failure to warn lawsuits should be pre-empted by federal regulations that require the warning label to match the name brand version.
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.
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.
For almost five years, the FDA has left proposed rules in limbo that were 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.
In the meantime, 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.