publication date: Jan. 15, 2021

FDA to update labels for generic cancer drugs with signing of MODERN Labeling Act

By Matthew Bin Han Ong

A new law has given FDA the authority to update the approved labeling on generics—including for many older cancer drugs.

The law, called the MODERN Labeling Act, was  bundled into the $900 billion coronavirus relief package that was passed Dec. 27. It allows FDA to identify drugs for which labeling updates would “provide a public health benefit.”

The measure is the result of advocacy initiated in 2017 by Friends of Cancer Research. “FDA-approved labeling routinely fall out of date even when products are still being actively marketed by the innovator company,” a November 2017 white paper by Friends states.

“The result is that most older drugs have aspects of FDA-approved labeling that need to be modernized to prevent the dissemination of incorrect information and to enable the communication of information pertinent to safe and effective prescribing.”

In a subsequent study, published March 2018 in Therapeutic Innovation and Regulatory Science, the group found that, of 43 cancer drugs approved between 1999 and 2011, 34 (79%) had at least one well-accepted off-label use.

In total, 253 off-label uses were identified: 91% were well accepted, and 65% were in cancer types not previously represented on labeling.

The paper concluded:

“The labeling for many cancer drugs, particularly for older drugs, is outdated. Although FDA-approved labeling can never be fully aligned with real-world clinical practice, steps should be taken to better align the two when high-quality data exist. Such steps, if taken, will assist patients and … Continue reading FDA to update labels for generic cancer drugs with signing of MODERN Labeling Act

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