Skip to content

Regulatory Focus – Drug Labels: Experts Note Importance of Faster Updates

Regulatory Focus – Drug Labels: Experts Note Importance of Faster Updates

The topic of cancer drug labels and how they can be updated more quickly, as well as how the labeling system needs to be reformed was front and center at several panels at the Friends of Cancer Research’s annual meeting in Washington, D.C. on Wednesday.


Janet Woodcock, director of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), noted her agency has been working on the issue of label updates for a number of years, particularly in oncology.

While acknowledging the agency can mandate label changes for safety issues, she noted there are now more than 450 products where an innovator drug’s label has been frozen in time because there are only generic versions of the drug still on the market and because under current regulations, generic drug labels must mirror their brand name reference products. Woodcock noted that there are even cases “where we know the label is wrong in some way.”


“We’ve developed some theories and ways where we can update some parts of generic labels, though we can’t add new indications without a great deal of effort,” Woodcock said, noting that it’s not just the indication that’s missing on some labels, but can include the dosage or pharmacology.


She added that the proposed rule to reform label updates (the finalization of which has been pushed back more than once) is workable, though industry has said it would be costly.


In oncology, the existence of additional indications on a label is often the difference between if a patient can obtain payment for a treatment or not, as payers in some cases will not pay for the off-label use of an oncology treatment and because prices have gotten so high, the option of paying out of pocket no longer exists, George Demetri, director of the center for sarcoma and bone oncology at the Dana-Farber Cancer Institute, noted.


Demetri questioned if there were more supplemental applications submitted to FDA, would that help with label updates?


Amy McKee, deputy director of FDA’s Office of Hematology and Oncology products, said that the latest iteration of the user fee agreement eliminated fees for supplements, noting that hopefully the change will help increase supplement submissions.


Woodcock noted that FDA has seen an uptick in efficacy supplements since the new user fee agreement was authorized.


And though McKee acknowledged that submitting lengthy data sets can be burdensome, FDA can only update labels when trial data is submitted. Other panels discussed complications with combination-product labeling and the goal of maximizing the data available through cross labeling, though legal and regulatory issues linger.

Other Comments

Richard Pazdur, director of FDA’s new Oncology Center of Excellence, speaking alongside the National Cancer Institute’s new director Ned Sharpless, discussed the practical implications of so many companies chasing after the same small indications, which he said, “probably isn’t the best use of resources.”


Pazdur also noted in a moment of caution for industry that FDA has probably already made a decision on an application before it is even submitted. And though FDA has added new and faster approval pathways in recent years, he said the regulatory structure at FDA has remained largely unchanged since the 1960s, which has added to difficulties as the development of cancer treatments has changed so much since then.


Pazdur noted that one of the biggest disappointments of the year was seeing the results from clinical trials with Merck’s Keytruda (pembrolizumab) in combination with other drugs to treat multiple myeloma. The trials were halted earlier this year.…