FDA Begins Updating Generic Chemotherapy Labels

Regulatory NewsRegulatory News | 13 November 2018 |  By 

As part of efforts to ensure older generic drug labels remain relevant, the US Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE) has begun updating generic chemotherapy labels.

Speaking at Friends of Cancer Research’s annual meeting on Tuesday, FDA Office of Hematology and Oncology Products (OHOP) Supervisory Associate Director Amy McKee explained the push to update the labels, known as Project Renewal, which will update about 40 generic chemotherapy labels that are still used in clinical practice but no longer have brand name reference products, so that the labels will appropriately reflect how the drugs are used today.
While joking that no one reads labels anyway, she noted the project will update the entire label so “you know the right doses and pediatric uses” as well as any new indications. She estimates that OCE will update five labels in the first year and do more as the time comes.
The initiative to update the labels is just one of several new initiatives the office is working on as it has grown from just one employee – OCE Director Richard Pazdur – to 12 employees now.
As far as obstacles for the new office, McKee noted that “funding and continued guaranteed funding is a major concern.” Other misconceptions she wanted to address include the fact that OCE and FDA in general do not stop reviewing a medicine once it wins its first approval. “We actually do get data in after an approval…we are constantly updating labels and reviewing postmarketing data,” she added.
Pazdur also discussed misconceptions around the breakthrough therapy designation, which was first developed by the Friends of Cancer Research. “Breakthrough was never meant to be a rating system – it was meant to encourage early dialogue [between sponsors and FDA]. There’s no such thing as giving too many of these out – if anything, you’d want more given out,” he said in response to some critics who say FDA designates too many new therapies as breakthroughs.

In addition to the label updates, OHOP is also reorganizing, according to deputy director Gideon Blumenthal. The office is moving from three clinical divisions to five, and safety analyses are being centralized within the immediate office.
As for misconceptions, Blumenthal took issue with those calling for overall survival in every trial, noting that a lot of times “you just can’t demonstrate survival benefits – can’t run a randomized trial.”
He also discussed ironing out the kinks of OCE the first time, noting potential plans to move to other disease-focused centers of excellence in, for instance, neurology or cardiology. “We have to get this first center right,” he said.


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