CHICAGO – U.S. Senator Dick Durbin (D-IL), Chair of the Senate Judiciary Committee, today held a news conference at Cook County Health to discuss the shortage of life-saving drugs for cancer patients. Last week, Durbin urged the Food and Drug Administration (FDA) to use the Agency’s authority to immediately address the ongoing shortage as it threatens the lives of patients nationwide. FDA has since agreed to import one of the drugs for which U.S. hospitals are seeing a shortage, but widespread problems with the drug and medical supply chain remain.
“I am pleased that FDA has taken this step and I hope it brings some relief to patients in need, but more must be done to prevent these shortages in the first place and to ensure that cancer patients never go through this again,” said Durbin. “I’ve worked with my colleagues since the beginning of COVID to pass provisions that strengthen our federal drug stockpile, enhance FDA’s visibility into pharmaceutical supply chains, and expand our domestic manufacturing capability so we are not as dependent on foreign supply chains for critical medical supplies. Receiving a cancer diagnosis and being told that there is a drug that can save you, but that you cannot get it because of a shortage, is simply unacceptable.”
“Cancer is difficult enough to live with, but not having access to the proper medication to help a patient combat such a deadly disease is beyond the pale,” said Cook County Board President Toni Preckwinkle. “Undoubtedly, medication shortages significantly impact disenfranchised communities that already struggle to receive the care and treatment they need for their cancer diagnosis. We stand with Senator Durbin and support his efforts to combat medication shortages.”
“Due to shortages of the chemotherapy drug Cisplatin, the first line medication to fight many head and neck, lung and gynecological cancers, health care providers across the nation are having to alter treatment plans for their patients. We need to be able to access these essential and effective medications to provide our patients with the best care possible. Lives depend on it,” said Israel Rocha, Jr., CEO, Cook County Health. “I am grateful for Senator Durbin’s leadership on this issue and for the FDA’s new plan to import medication from other countries. We must continue to collaborate on long-term solutions to address drug shortfalls and ensure all patients have access to the treatments they need.”
At the end of 2022, there were 295 active medication shortages—a 30 percent increase since 2021—of mostly generic drugs ranging from antibiotics and anesthetics to cardiac mediations and chemotherapy drugs. Chemotherapy drugs, which often cannot be substituted for other drugs, are experiencing some of the most prolonged shortages with 17 drugs in shortage, the fifth most of any drug category.
Two of the most critical cancer drugs currently in shortage are cisplatin and carboplatin. An FDA inspection of a manufacturing facility in India found quality control issues with cisplatin production. With production halted, doctors turned to carboplatin, which created a surge in demand that led to a shortage of that chemotherapy drug. Patients and providers nationwide have reported difficulty in obtaining these drugs—leading to delayed or denied care for cancer patients.
This shortage is particularly problematic for people facing a cancer diagnosis given that in most cases, there are no alternative treatment options available for patients. While cisplatin and carboplatin are front-line medications that successfully treat hundreds of thousands of U.S. cancer patients every year, problems at a single facility in India have caused major disruptions in the supply chain. With limited supplies, doctors are faced with difficult decisions to ration care only for their sickest patients. According to a 2020 study published in the British Medical Journal, every month delayed in cancer treatment can raise the risk of death by approximately ten percent.
In addition to an over-reliance on foreign manufacturing—roughly 80 percent of all ingredients and raw materials going into generic prescription drugs come from China or India—there are other systemic reasons for drug shortages. Pharmaceutical companies do not make huge profits on older generic drugs. Thus, given limited profit margins, they either exit the market entirely or are unable to invest in newer equipment, processes, or management practices that could prevent quality-related manufacturing breakdowns that lead to shortages of critical drugs.
In the 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act, Durbin authored a bipartisan provision directing the National Academies to examine the dependence on foreign sources for drug manufacturing. The resulting report recommended an intentional blend of stockpiles, domestic manufacturing capacity, and overlapping sources from overseas for diversification.
The CARES Act also provided FDA with new authorities to enhance its visibility to prevent and mitigate shortages—including:
- prioritized FDA review period for applications of generic drugs in shortage;
- required manufacturers to notify FDA of interruptions to their supply chain; and
- established a risk management system for drug manufacturing.
Additionally, the Fiscal Year 2023 (FY23) omnibus appropriations bill, which passed in December 2022, included Durbin’s bipartisan legislation to strengthen domestic manufacturing and supply chain readiness by enabling the Strategic National Stockpile to consistently sell into the commercial market and replenish supplies—which would both maintain fresh supply and foster market demand.