Home health remedies Shortage of childhood cancer drug hot top during Senate hearing for new...

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

38
0
SHARE

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

Webinar

Striving for Zero in Quality & Manufacturing

Pharmaceutical and medical device manufacturers strive towards a culture of zero – zero hazards, zero defects, and zero waste. This on-demand webinar discusses the role that content management plays in pharmaceutical manufacturing to help companies reach the goal of zero in Quality and Manufacturing.

“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.

Source link

LEAVE A REPLY

Please enter your comment!
Please enter your name here

one × 3 =