Having informed FDA this summer that it was withdrawing from the market for vincristine, a generic injectable that is highly effective for some childhood cancers, Teva Pharma has now reversed course. It will restart production “in our plant in the US, which provides the fastest route to market,” according to a statement from Teva that was released by Change.org on Nov. 13. “Product will be available for patients in the US as early in 2020 as possible,” says the statement.
According to Change.org, a self-styled “public benefit company” that enables the public to start an online petition and then gathers co-signers to that petition, the petition gathered 215,000 signatures. “There is incredible power in the activism of cancer survivors and cancer patients,” said Michael Jones, managing director of Change.org. “This petition – started by a cancer survivor herself – built international awareness about the shortage of this life-saving drug, and made this one of the biggest health petitions on Change.org in 2019.” It’s less clear whether the Change.org action changed Teva’s thinking, or the bad publicity when the New York Times highlighted the looming shortage of vincristine in an Oct. 14 news article (that article was cited in the original petition). It so happened that that article appeared around when FDA completed a new analysis of drug shortages—which have been endemic in the US healthcare system for at least the current decade—and at a time when drug manufacturer practices are under a spotlight, either for high drug prices, or opioid marketing and other practices.
For its part, the statement sent by Teva to Change.org somewhat changes the picture. “It is important to note that Teva has a history of being a strong, responsible corporate partner and when Teva removed vincristine from the market earlier this year there was no indication at all of a possible shortage. In fact, the company was only supplying 3% of the market and without any information to the contrary, anticipated that could quickly and easily be absorbed by the brand manufacturer supplying the other 97%. And as noted, we offered importation from other countries but were assured that was not needed,” says the statement, attributed to VP corporate communications & brand, Kelley Dougherty. (According to the NYT, the other 97% is provided by Pfizer.)
Generic injectables are the category of drugs cited frequently in shortage surveys; they are not easy to manufacture, requiring a sterile environment. The FDA report notes that poor economics routinely drives production of them down to one or a few, and then when a production upset occurs (or an unfavorable business decision), a shortage quickly erupts. Oncologists are continuing to watch the situation for another cancer drug, BCG (bacillus Calmette-Guérin, used for bladder cancer) whose only supplier is Merck. On the drug-shortages web page of the American Soc. of Health-System Pharmacists, BCG has “supply constraints” and is “under allocation” by Merck. Based on data gathered by the Univ. of Utah Drug Information Service, there are 126 drug shortages in the US currently.