Representatives Debbie Dingell (D-MI) and Tim Walberg (R-MI) On May 24, 2023, led the Michigan Congressional delegation in sending a bipartisan letter to Food and Drug Administration (FDA) Commissioner Dr. Robert Califf to urge the Administration to take immediate action to mitigate the effects of the nationwide shortage of chemotherapy medications. Every member of the Michigan delegation signed onto the letter as multiple hospitals across the state are experiencing shortages.
“The FDA is currently reporting a nationwide shortage of cisplatin and carboplatin, two essential chemotherapy drugs that are often used to treat lung, gynecologic, and breast cancers, ”the lawmakers write.“
The shortage of cisplatin was reported by the FDA on February 10, 2023, followed by the shortage of carboplatin on April 28, 2023. The FDA also reported a shortage of methotrexate, a chemotherapy drug used in the treatment of several types of cancer, on March 13, 2023.”
“These chemotherapy drug shortages come amid a shortage of other critical cancer medications. Taken together, they are straining the ability of doctors to provide the best course of treatment for their patients. We are hearing directly from impacted hospitals urging immediate action to address these alarming challenges, ”the lawmakers continue.
“Patients should not have to worry whether they can access the scarce chemotherapy drugs they need on top of the daily stressors accompanied by a cancer diagnosis. But in the wake of these shortages, doctors and patients are being forced to make difficult decisions to turn to alternative treatments that could result in worse outcomes.”
“We understand these shortages have been fueled, in part, by a halt in production at Intas Pharmaceuticals – an India-based company that manufactures methotrexate, carboplatin, and cisplatin – after FDA inspectors identified quality-control violations, ”the lawmakers conclude.
“We appreciate the robust oversight the FDA conducts to ensure medications received from overseas facilities are held to high quality standards, but more must be done to ease the troubling supply disruptions that also put patients at risk.
The Michigan delegation is requesting an immediate briefing from the FDA, as well as answers to the following questions:
- How is the FDA working with manufacturers to mitigate the shortage of chemotherapy drugs cisplatin, carboplatin, and methotrexate?
- As doctors and patients continue turning to alternative drugs, should we expect additional shortages of other chemotherapy drugs?
- What flexibilities can the FDA provide to help manufacturers swiftly increase their production of cisplatin, carboplatin, and methotrexat
- When does the FDA anticipate the chemotherapy drug shortage to alleviate?
- How is FDA leveraging temporary importation and other flexibilities to work with industry on bringing other manufacturers into the market to alleviate the shortages of cisplatin, carboplatin, and methotrexate?
View the full text of the letter here.
Original source can be found here.
