Teva to Resume Production of Vincristine After Widespread Shortages
With vincristine in short supply, Teva will resume production of the chemotherapy agent following its previous decision to remove the product from the market.
Teva announced it will resume manufacturing vincristine, a widely-used chemotherapy agent, following its previous decision to discontinue production, the company announced on Wednesday.
In a statement posted on its Twitter page, Teva indicated that the product will be available again for US patients as early in 2020 as possible.
Vincristine is used to treat several types of blood cancers, including acute lymphoblastic leukemia, one of the most common childhood cancers. Teva discontinued production of the medication in early June 2019, leaving Pfizer as the sole supplier. Since then, manufacturing delays and increased demand have resulted in shortages of the drug, causing considerable concern within the pediatric patient community. Pfizer reported that it expects to fully recover by January 2020.1
In response to the shortage, 1 circulating petition urged the US government to intervene and another, which has more than 200,000 signatures, directly requested that Teva resume production. Health care providers have voiced concerns about the need to ration doses of the drug for their patients if shortages persist.2
Generic injectable drugs are most vulnerable to shortages, mostly due to fewer suppliers, long lead times, and manufacturing complexity, according to the FDA.3 The agency recently released a report highlighting key contributors to drug shortages such as this, indicating that major changes are needed in the marketplace to mitigate the impact of supply disruptions.
According to the Twitter post, when Teva removed vincristine from the market, “the company was only supplying 3% of the market and, without any information to the contrary, anticipated that that volume could quickly and easily be absorbed by the brand manufacturer, which was supplying the other 97%.”
Now, Teva has decided to re-introduce the product and plans to manufacture it in its US plant, “which provides the fastest route to market.”
In October, the Mitigating Emergency Drug Shortages (MEDS) Act was introduced in the Senate. The legislation intends to increase authority for the FDA, enhance manufacturing reporting requirements, and provide new market-based incentives as a means to combat drug shortages. Following the 200 plus drug shortages reported in 2018, health care organizations, including the American Society of Health-System Pharmacists, are ready to help advance the MEDS Act.
In the meantime, providers can follow several recommendations to help prepare and plan for a shortage crisis. In addition, pharmacists can stay updated on drug shortages by regularly visiting ASHP (ashp.org/Drug-Shortages) and FDA (fda.gov/drugs/drug-safety-and-availability/drug-shortages) websites.
- Pfizer Inc. Supply Update Notification for Vincristine Sulfate Injection, USP Presentations. FDA’s website. October 18, 2019. https://www.fda.gov/media/131865/download. Accessed November 14, 2019.
- Robin RC. Faced With a Drug Shortfall, Doctors Scramble to Treat Children With Cancer. The New York Times. October 14, 2019. https://www.nytimes.com/2019/10/14/health/cancer-drug-shortage.html.
- FDA. Drug Shortages: Root Causes and Potential Solutions. 2019. FDA’s website. https://www.fda.gov/media/132058/download. Accessed October 21, 2019.