Pfizer is playing a new role in the dramas that often surround drug shortages. While manufacturing issues at its Hospira unit have sometimes been responsible for hospital drug shortages, Pfizer is now trying to fill a serious shortfall after Teva Pharmaceutical discontinued production of a chemo drug used to cure children of serious cancers.
It is ramping up production of vincristine—often used with other drugs to treat leukemia, brain tumors and lymphomas—after Teva in July notified the FDA that it had made the “business decision” to discontinue production. Its move has left pediatric oncologists scrambling to find supplies.
“Due to a competitor’s outage, we are expediting additional shipments of this critical product over the next few weeks to support three to four times our typical production output. Pfizer is committed to providing this important medicine to patients,” Pfizer said today in an email.
The New York Times reports that vincristine is so widely used that the shortage is affecting clinical trials as well as treatments.
“Vincristine is our water. It’s our bread and butter. I can’t think of a disease in childhood cancer that doesn’t use vincristine,” Yoram Unguru, M.D., a pediatric oncologist at the Herman and Walter Samuelson Children’s Hospital at Sinai in Baltimore, tells the NYT.
In an emailed statement, Teva claims that its decision to leave the market was not the cause of the shortage. It said that based on data from 2017, it found its share of the market was never more than 15% and was a little as 3% per month on average this year.
"Based on this information about usage and availability and an annual business assessment, Teva decided to discontinue the product, and alerted FDA of its decision in March 2019." its statement said.
With margins on generics having gotten very thin in recent years, many drugmakers have given up production of products where they are not dominant in the marketplace. There are currently 202 drug discontinuations listed on the FDA Drug Shortages website.
Playing the hero in a drug shortage is a turnabout for Pfizer, which has been under pressure to upgrade several plants after manufacturing issues left certain drugs in very short supply. Problems at a Hospira plant in Kansas led to shortages at hospitals of some injected pain meds. Issues at another Pfizer facility that makes injectors resulted in shortages of Mylan’s popular EpiPen for treating anaphylactic shock.