Senator Reverend Warnock, Representative Carter led their Georgia colleagues in pressuring the U.S. Food and Drug Administration (FDA) to increase transparency around their efforts to address chemotherapy drug shortages and to bolster efforts to prevent these shortages in the future
Senator Reverend Warnock, Representative Carter’s effort was joined by seven members of the Georgia House of Representatives delegation
Georgia lawmakers to the FDA: “Georgia cancer patients and their doctors deserve to choose treatment based on best evidence and what works for the patient without the additional burden of worrying about the availability and safety of drugs”
ICYMI from the AJC: Cancer drug shortage prompts Georgia lawmakers to raise issue with FDA
Washington, D.C. – Today, U.S. Senator Reverend Raphael Warnock (D-GA) and U.S. Representative Carter (R-CA-01) led a bipartisan delegation of Georgia’s congressional delegation in pressuring the U.S. Food and Drug Administration (FDA) to increase transparency around their efforts to address chemotherapy drug storages and to bolster efforts to prevent these shortages in the future. The bipartisan effort was joined by seven Georgia members of the U.S. House of Representatives: U.S. Representatives Rick Allen (R-GA-12), Stanford Bishop (D-GA-02), Hank Johnson (D-GA-04), Barry Loudermilk (R-GA-11), Lucy McBath (D-GA-07), Rich McCormick (R-GA-06), and Austin Scott (R-GA-08).
“Georgia cancer patients and their doctors deserve to choose treatment based on best evidence and what works for the patient without the additional burden of worrying about the availability and safety of drugs,” said Senator Reverend Warnock and his colleagues to FDA.“We are glad that the FDA is taking actions to mitigate these drug shortages. This includes working with additional manufacturers to increase supplies of these drugs. However, we are concerned by the lack of transparency from the FDA about these suppliers, especially since the FDA has begun importing cisplatin injections from Qilu Pharmaceutical, which is not FDA- approved and manufactures the injections in China. We are also alarmed by the lack of timeline and detail on when any new, safe imports of carboplatin will begin and from where they will be imported. The FDA must work quickly to assist in resolving shortages of chemotherapy drugs and ensure that the United States is better equipped to address drug shortages in the future.”
On December 2, 2022, the Food and Drug Administration (FDA) issued a report on several failures occurring at the Intas Pharmaceuticals production plant in Ahmedabad, India. This production plant is a major manufacturer of chemotherapy drugs cisplatin and carboplatin, including over 50 percent of the U.S. supply of cisplatin. Intas closed this production plant, resulting in shortages of carboplatin and cisplatin that has created a chain reaction with increased demand for other chemotherapy drugs leading to several other shortages. While the FDA has begun working with other foreign drug manufacturers to increase supplies of these drugs, the agency has not provided clear details on when additional imports will begin and in what quantity. The effect of these shortages is already beginning to impact patients and doctors across Georgia. As a result, doctors are forced to make choices on treatment for their patient based on availability of drugs, rather than on what the best option is for the patient.
Read the full letter to FDA Commissioner Califf HERE and below:
Dear Commissioner Califf:
We write to request information on the U.S. Food and Drug Administration’s (FDA) response to the ongoing shortage of chemotherapy drugs, including measures the agency is taking to ensure the safety of imported replacement drugs.
On December 2, 2022, the FDA released a report documenting severe deficiencies at the Intas Pharmaceuticals production plant in Ahmedabad, India. These failures include issues with procedures for preventing microbiological contamination and reports of trucks inappropriately disposing of shredded documents intended to ensure product safety.Following this report, Intas willingly halted production and distribution of its chemotherapy drugs, which include cisplatin, carboplatin, and methotrexate. The facility has reportedly now halted production for eight months. The closure of this production plant, which is responsible for about 50 percent of the U.S. supply of cisplatin, has led to ongoing shortages. Moreover, the closure of the Intas production plant has started a chain reaction, with higher demand for alternative chemotherapy drugs, creating additional shortages.
We have heard from cancer patients and doctors across Georgia who are confronting these shortages. Providers at cancer centers have started to alter treatment programs and delay preferred therapies due to limited drug availability. Cancer hospitals in Georgia are currently tracking several drugs other than cisplatin as limited in supply, including carboplatin, fludarabine, fluorouracil, methotrexate, dacarbazine, idarubicin and Bacillus Calmette-Guérin (BCG). Georgia cancer patients and their doctors deserve to choose treatment based on best evidence and what works for the patient without the additional burden of worrying about the availability and safety of drugs.
We are glad that the FDA is taking actions to mitigate these drug shortages. This includes working with additional manufacturers to increase supplies of these drugs. However, we are concerned by the lack of transparency from the FDA about these suppliers, especially since the FDA has begun importing cisplatin injections from Qilu Pharmaceutical, which is not FDA- approved and manufactures the injections in China. We are also alarmed by the lack of timeline and detail on when any new, safe imports of carboplatin will begin and from where they will be imported.
The FDA must work quickly to assist in resolving shortages of chemotherapy drugs and ensure that the United States is better equipped to address drug shortages in the future.
In light of these concerns, we respectfully request that the FDA respond to the following questions by September 18, 2023:
- How is the FDA working with Intas Pharmaceuticals and its subsidiary, Accord Healthcare, to quickly and safely reopen the production plant in Ahmedabad, India? Is there a timeline for when Intas Pharmaceuticals will resume production?
- What is the status of the FDA’s engagement with additional drugmakers outside of Qilu Pharmaceuticals regarding importing chemotherapy drugs?
- How is the FDA ensuring that any chemotherapy drugs that are imported to the U.S. meet U.S. drug safety standards?
- What is the FDA doing to resolve shortages of other chemotherapy drugs outside of carboplatin and cisplatin?
- How can Congress address the root causes of drug shortages, particularly those affecting chemotherapy drugs so that in the future, the closure of one manufacturing plant will not affect half of the U.S. supply of a critical drug?
We look forward to receiving your response. We are committed to working with the FDA to address the chemotherapy drug shortages so that cancer patients in Georgia and around the country can access the treatment they need.
Sincerely,
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