FDA to update generic labeling rules

The FDA plans to require all makers of a drug, generic and branded, to have essentially the same labeling and set out the same warnings. The move comes two years after generic drugmakers were protected by a Supreme Court ruling for not updating labels and less than two weeks after the court said generic drugmakers could not be sued in state court for similar issues.

Right now, generic drugmakers are prevented from updating their labels for potential safety issues without special FDA approval, although makers of the branded drugs can. According to Reuters, the FDA on Wednesday laid out a plan on the Website of the Office of Management of Budget that would require all drugmakers to update their labels if the FDA has approved a change by one company. The New York Times reports that the agency expects to publish a new rule by September. An FDA spokeswoman told The Times that the FDA has been considering this for some time but could not say at this point exactly what the rule would require.

In 2011, the group Public Citizen asked the FDA to change its rules and allow generic drugmakers to update the labeling on their products. That request came in response to another Supreme Court ruling that year that specifically said generics makers aren't liable for safety warnings on their drug labels because the labeling must duplicate the language on branded versions and can only be changed with FDA approval. Public Citizen lauded the proposed change, which it claims is needed to fill the "regulatory gap" that now exists between branded and generic drugs, USAToday reports. About 80% of the drugs U.S. consumers now take are generics.

Ralph Neas, president of the Generic Pharmaceutical Association (GPhA), told USAToday that the labeling changes should fall to the FDA. "Decisions on safety and efficacy of prescription drugs should rest in the hands of the FDA, the only body with the scientific knowledge, regulatory experience and complete data that is needed to make these decisions," he said.

But Dr. Sidney Wolfe, founder of Public Citizen's Health Research Group, said, "The proposed rule is a classic example of harm reduction," Reuters reports. "When finalized after public comments, it will provide added protection to the tens of millions of people who regularly use generic drugs."

The Supreme Court just recently ruled 5-4, in a decision that broke along ideological lines, that a patient could not expect a state court case to preempt federal law and sue when a drug design has already been approved by the FDA.

- here's the proposed rule
- read the Reuters story
- more from USA Today
- more from The New York Times

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