Teva in March notified the FDA that it had made a business decision to quit manufacturing vincristine, a cancer drug commonly used to treat children. Now, after a national backlash over the shortage that followed, the drugmaker has decided to return it to market as soon as possible.
In a Tweeted statement Wednesday, the company said its version of the drug will be available in the U.S. as early as next year. Pfizer is currently the only company selling vincristine in the U.S.
“Because vincristine is such a lifesaving medicine—and there is no reliable single supply anticipated in the near term—we will re-introduce the product and plan to manufacture it in our plant in the U.S., which provides the fastest route to market. Product will be available for patients in the U.S. as early in 2020 as possible,” Teva said.
After Teva decided to give up production of vincristine, Pfizer said it was unable to keep up with supply. The shortage that materialized led doctors to protest. Oncology nurse Liliana Haas, who credited the drug with helping her survive childhood leukemia, started a petition on Change.org that the organization says drew more than 215,000 signatures and comments. National media drew attention to the shortage as doctors lamented unavailability of a drug they relied on to keep children alive.
Teva has resisted the idea that its action was responsible for the shortage, saying that when it made its decision, “there was no indication at all of a possible shortage.” The company said it believed its share of the market could be absorbed by Pfizer.
That turned out not to be the case. Pfizer’s Hospira unit notified the FDA that there would be a shortage as demand outran supply and began rationing supplies. In a “Dear customer” letter in October, Pfizer said it expected new deliveries of the drug soon and to fully recover from the shortage by January of next year.
After learning that “manufacturing delays would result in a shortage of vincristine, Teva said it began working with the FDA to see how it can help. It says it has offered to import the drug from other countries but has now landed on manufacturing in the U.S. as 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.