WASHINGTON — Today, U.S. Senator Amy Klobuchar (D-MN) urged the Food and Drug Administration (FDA) to address the shortage of Vincristine – a drug used to treat many childhood cancers. In a letter to FDA’s Acting Commissioner Norman Sharpless, Klobuchar highlighted recent news reports about the Vincristine shortage in the United States and asked several questions regarding the FDA’s actions leading up to the shortage. Klobuchar also questioned whether the required timeframe to notify the FDA when a drugmaker plans to discontinue production was followed, as well as the FDA’s future plans to mitigate shortages.
“I write to express my serious concern about the recent shortage of Vincristine, a critical drug used to treat many childhood cancers—including more than 1,000 patients at Children’s Minnesota each year. An October 14, 2019 news report indicated that the drug’s limited supply is forcing physicians across the country to consider rationing, lowering, or skipping doses for patients. Since there is no appropriate substitute for the drug available in the U.S., the current lack of Vincristine could jeopardize the health and well-being of vulnerable children across the country unless the shortage is swiftly resolved,” Klobuchar wrote.
The full text of the letter can be found HERE and below:
Dear Acting Commissioner Sharpless:
I write to express my serious concern about the recent shortage of Vincristine, a critical drug used to treat many childhood cancers—including more than 1,000 patients at Children’s Minnesota each year. An October 14, 2019 news report indicated that the drug’s limited supply is forcing physicians across the country to consider rationing, lowering, or skipping doses for patients. Since there is no appropriate substitute for the drug available in the U.S., the current lack of Vincristine could jeopardize the health and well-being of vulnerable children across the country unless the shortage is swiftly resolved.
According to reports, the Vincristine shortage is linked to a Pfizer manufacturing delay following Teva Pharmaceuticals’ withdrawal from the market earlier this year. Previously, just two drugmakers manufactured the drug in the U.S. until Teva stopped production. Teva has indicated that it informed the Food and Drug Administration (FDA) that it would stop manufacturing the drug in March 2019, and in July 2019, the FDA posted a statement that, “Teva made a business decision to discontinue the product.”
While Pfizer is working to expedite production of Vincristine to meet the full market need by January at the latest, the next shipment is not planned until later this month, and notably, this is not the first time that patient demand of Vincristine has been met with a limited supply.
The FDA has previously taken action to help resolve drug shortages, including allowing for the temporary importation of foreign drugs with appropriate safeguards—for example, four medications to fight cancer in 2011. In a May 2018 statement about drug shortages, the agency reiterated a willingness to “explore importation of a product from a foreign manufacturing source until the shortage is resolved.”
It is crucial that Vincristine’s current drug shortage is quickly addressed. Accordingly, I respectfully request answers to the following questions:
- What actions will you take to mitigate the Vincristine shortage should the drug remain in limited supply after December 2019? Have you looked for other manufacturing sources outside of the country? If not, why not? If so, will the FDA explore temporary importation of the drug? What actions will you take to prevent future drug shortages of Vincristine once the current shortage is resolved?
- Did the FDA contact Teva and Pfizer to ask about the status of their Vincristine supplies after reports surfaced in the spring of 2018 to ensure the companies could continue to meet demand? If not, why not? If so, please provide a copy of any responses you received.
- Did Teva notify the FDA of its plan to discontinue production of Vincristine in March 2019? If so, why is the FDA notice dated July 5, 2019? What strategic planning and communication occurred between the FDA, Pfizer, hospitals, physicians, and patients between March 2019 and July 2019 in anticipation of potential market disruption?
Thank you for your prompt attention to this important matter.
Sincerely,
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- LTR - Drug Shortage - Vincristine.pdf (161.9 KBs)