Thousands of cancer patients across the United States are unable to access life-saving treatments and medicines due to chronic widespread shortages, according to recent data.
Between 2021 and 2022, new drug shortages increased by nearly 30 percent, according to the report. By the end of 2022, active drug shortages were at a record five-year high of 295.
“While the average drug shortage lasts about 1.5 years, more than 15 critical drug products have been in shortage for over a decade,” the report stated. “Shortages continue to have devastating consequences for patients and health care providers, including medication errors and treatment delays, and in some cases, have led to doctors having to ration lifesaving treatments.”
Doctors Forced to Ration Life-Saving Drugs
“I don’t know of a time that’s worse than this,” Dr. Julie Gralow, the chief medical officer and executive vice president of the American Society of Clinical Oncology, told NBC News. "What’s different about this shortage is, I think, it’s just the broad applicability of these drugs, how important they are, you know, globally, in the U.S., in the treatment of many diseases.”Amid the shortages, some doctors have reported rationing much-needed cancer drugs or having to decide which patients will receive the drugs first.
In its March report, the Homeland Security and Governmental Affairs Committee noted that an insufficient supply chain and an overreliance on foreign and geographically concentrated sources for critical drugs, as well as limited domestic manufacturing capabilities, are creating both health and national security risks.
The report noted that the number of Chinese-based Active Pharmaceutical Ingredients (API) manufacturers registered with the FDA more than doubled from 188 in 2010 to 445 in 2015. In 2021, India accounted for the majority of FDA-approved API facilities, according to the report.
“These shortages have cascading effects on patient care, causing delays in treatment, increasing the risk of medication errors, and requiring the use of less effective alternative treatments,” the report said. “Hospitals have also experienced increased costs, medication waste, and limited staffing capacity to address and remedy shortages.”
Despite the findings of the report, the FDA said in an update on June 6 that it is working with the Chinese drugmaker Qilu Pharmaceutical to temporarily import the chemotherapy drug cisplatin to address shortages of the drug.
According to the update, the 50-milligram cisplatin vials, which are used to treat a number of cancers, will be distributed in the United States market by Toronto-based pharmaceutical company, Apotex.
FDA Turns to Chinese Drug Maker Amid Shortages
In a statement on Twitter, FDA Commissioner Dr. Robert Califf said the agency “recognizes the importance of a stable, safe supply of critical drugs used in oncology, especially those used in potentially curative or life-extending situations.”“Today, we’ve taken steps for temporary importation of certain foreign-approved versions of cisplatin products from FDA-registered facilities and used regulatory discretion for continued supply of other cisplatin and carboplatin products to help meet patient needs,” Califf said, adding that the quality of the medications have been carefully assessed to ensure they are safe to be used by patients.
“The public should rest assured that we will continue all efforts within our authority to help the industry that manufactures and distributes these drugs meet all patient needs for the oncology drugs impacted by shortages,” the FDA commissioner said.
In its March report, the Homeland Security and Governmental Affairs Committee stressed the importance of having diversity when it comes to sourcing and manufacturing much-needed medications to ensure that unexpected disruptions do not lead to widespread shortages.
Additionally, the committee urged the federal government to build upon previous efforts to incentivize advanced domestic manufacturing technologies for critical drugs through private-public partnerships.
