Shortage of childhood cancer drug hot topic during Senate hearing for new head of FDA 

The nominee for FDA commissioner Dr. Stephen Hahn pledged to a Senate committee that he is committed to working on the problem of drug shortages. (YouTube )

The shortage of childhood cancer drug vincristine was front and center during the Senate hearing for Stephen Hahn, the chief medical executive at MD Anderson Cancer Center who is expected to be confirmed as the FDA Commissioner. 

Hahn, a radiation oncologist, told the Senate committee that as a front-line physician, he has dealt personally with the problem of drug shortages. 

RELATED: Teva to produce children's chemo drug again as shortage leads to backlash


Simplify and Accelerate Drug R&D With the MarkLogic Data Hub Service for Pharma R&D

Researchers are often unable to access the information they need. And, even when data does get consolidated, researchers find it difficult to sift through it all and make sense of it in order to confidently draw the right conclusions and share the right results. Discover how to quickly and easily find, synthesize, and share information—accelerating and improving R&D.

“This is an incredibly serious issue….  Telling parents and a child that you don't have vincristine to treat their cancer…no physician, wants to be in that position,” Hahn said during the hearing. 

The drug was in the spotlight this month when Teva said it would restart production of vincristine just months after it gave up manufacturing the chemo drug, leaving Pfizer as the only U.S. supplier. While Teva says its share of the market was minimal, Pfizer was unable to keep up with demand and a shortage materialized of vincristine, a treatment for childhood leukemia and other cancers. 

The shortage drew quick and heated criticism from parents and doctors which led some members of Congress to speak out. Senator Susan Collins of Maine mentioned it in the hearing when she extracted a promise from Hahn to work on the drug shortage issue. 

RELATED: FDA Commissioner nominee Hahn promises to put science above politics

Pfizer has said it expects to recover from the shortage in January. Teva says it will reintroduce the product and, by manufacturing it in a U.S. plant, will have its version available as early next year as possible. 

Teva has said that after learning that “manufacturing delays” would result in a shortage of vincristine, it began working with the FDA to see how it can help and decided that manufacturing in the U.S. is the best answer.

“Teva takes its responsibility to patients seriously, and I encourage you to read more about our efforts in our latest social impact report (PDF),” it said in its statement.


Suggested Articles

At one point, Novartis even offered up $90 apiece for the inclisiran developer but would later say even $85 was too much, a securities filing shows.

Sanofi spent months hyping its Tuesday investor event, and new CEO Paul Hudson certainly laid out a different vision for the drugmaker at the confab.

After more than 10 years as partners, Sanofi and Regeneron are splitting up their deal to comarket PCSK9 med Praluent and immunology drug Kevzara.