Decision Maker Response

Teva Pharmaceuticals’s response

Nov 13, 2019 — Teva has been working in the best interest of patients and offering the FDA assistance since the company was first made aware that there was a shortage being caused by manufacturing delays of the available product. Offers included importing product from other countries and to begin manufacturing in the US again as quickly as possible. We were assured they would let us know if they needed us to assist.

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. 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.

Teva takes its responsibility to patients seriously, and I encourage you to read more about our efforts in our latest social impact report: https://www.tevapharm.com/files/responsibility/teva_social_impact_report_2018.PDF