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FDA Delays Generic Drug Label Rule––Again

Generic companies aren’t required to update safety labeling

In 2013, the FDA proposed changing labeling rules to create “parity” between generic and brand-name drug makers for how they update their labels, exposing generic companies to legal liability if they fail to warn of a drug’s risks. The rule was widely expected to be introduced this spring, but the agency has decided to put off the decision until April 2017, according to a report posted on the STAT website.

This marks the third time since the FDA proposed the rule that it has been shelved in the face of opposition from the pharmaceutical industry and some lawmakers. The delay comes one month after the House Appropriations Committee proposed a spending bill that would prevent the FDA from using its funding to enact the rule as early as this summer.

Since the Hatch–Waxman Act was passed in 1984, generic drug makers have not been required to run tests to prove that their medications are the same as brand-name drugs, nor are they required to upgrade product labels with new safety data.

The FDA originally proposed its new rule after a 2011 Supreme Court decision held that federal law does not permit generic drug makers to independently make changes to their product labels and, therefore, the companies should not be held accountable for failing to warn the public about safety risks. This ruling sparked an outcry that generic labeling would be insufficient to warn patients about the risks associated with numerous medications. Generic drugs now account for an estimated 88% of all prescriptions filled in the United States, according to the IMS Institute for Healthcare Informatics.

For their part, generic drug makers are concerned that, if enacted, the rule would motivate lawyers to find ways to make the companies appear negligent if they do not move quickly enough to add newly learned safety information to labels. At one point, the Generic Pharmaceutical Association, an industry trade group, underwrote a white paper claiming that the cost of added litigation could add $4 billion to the nation’s health care bill.

Sources: STAT; May 19, 2016; and Federal Register; November 13, 2013. 

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