The authors of the letter on the other hand, want the FDA to review the safety of the You&i program in the context of the approved drug label.
The FDA should take another look at ibrutinib and make some necessary changes, said letter coauthor Mark J. Ratain, MD, of the University of Chicago.
“The FDA should reconsider whether the drug can be prescribed as labeled,” Dr. Ratain said in an interview. “I would like to see the pricing changed to linear [constant $/mg] pricing, so that prescribers and patients can select the most appropriate strength.”
Dr. Brian T. Hill