The Biden administration on Monday announced major chemotherapy drug, cisplatin, is back “to near 100% of pre-shortage levels,” according to a memo first obtained by Scripps News.
While the administration says progress addressing the nationwide shortage of cancer drugs is being made, it acknowledged more needs to be done to ensure patients receive critical care.
The shortage of 15 cancer drugs prompted warnings from medical organizations over the summer about the impact of delayed treatment, including three widely used generic drugs — cisplatin, carboplatin, and methotrexate. However, even as the White House highlights the strengthening supply chain, those three drugs remain in shortage, according to the Food and Drug Administration's website. They are just part of the broader ongoing drug shortages, which include many generic drugs.
In June, the FDA announced it would allow the importing of cisplatin to help alleviate the strain. An FDA official said the agency is continuing to look at temporary importation for all three drugs.
Later this week, President Joe Biden will convene his Cancer Cabinet, where the issue could be discussed, but ahead of that meeting the White House has outlined steps it believes are helping strengthen the supply chains for the widely used cancer drugs.
More than half of respondents said shortages of chemotherapy drugs were "critically impactful" in a summer survey released in July by the ASHP Drug Shortage Resource Center with data from the University of Utah Drug Information Service, meaning the shortages required rationing, canceling, or delaying cancer treatment. Meanwhile, the National Comprehensive Cancer Network found of its 27 member institutions who participated in a survey, 93% experienced a shortage of carboplatin and 70% of cisplatin, and while some institutions were able to continue treating patients, 16% reported treatment delays.
“Ensuring every American has access to the tools and interventions that exist today to prevent, detect, and treat cancer — and to the breakthroughs we are advancing in the Biden-Harris Administration — is essential to achieving the Biden Cancer Moonshot goal of ending cancer as we know it,” said a new blog post from the White House Office of Science and Technology Policy.
Advancing the fight against cancer and bolstering supply chains have been key pillars in Biden’s agenda.
“Cisplatin shortages have impacted the oncology community in a major way over the last year, year-and-a-half,” Dr. Shikha Jain, associate professor of Medicine at University of Illinois Cancer Center told Scripps News. “While it seems like that’s getting better, other chemotherapy drug shortages are still continuing to severely impact cancer patients.”
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Jain pointed to a shortage of 5-FU (5- fluorouracil), which is a chemotherapy drug, and a first line for most gastrointestinal cancers.
“It's been a balancing act of which drugs do we have, and which do we not have,” she explained.
The administration points to manufacturing and supply chain issues in the drug shortage, including products discontinued over time due to economic reasons and manufacturing site closures cutting the supply of the three generic drugs nearly in half this year. The FDA previously found significant violations at a manufacturer's plant in India. The company, which utilized the manufacturer, has indicated it’s started to release inventory again after halting distribution, according to an FDA official.
The FDA stated it “recognizes the potential impact that lack of availability of certain products may have on health care providers and patients. While the agency does not manufacturer drugs and cannot require a pharmaceutical company to make a drug, make more of a drug, or change the distribution of a drug, the public should rest assured the FDA is working closely with numerous manufacturers and others in the supply chain to understand, mitigate and prevent or reduce the impact of intermittent or reduced availability of certain products.”
The administration said the FDA has worked closely with manufacturers to find ways to increase manufacturing capacity and bring companies back to the market for generic carboplatin and cisplatin, while it’s also worked with manufacturers of generic methotrexate for injection on increasing supplies. According to the blog post, actions have helped bring the cisplatin supply to nearly 100% of pre-shortage levels and are helping with shortages of carboplatin.
Actions included the FDA allowing 14 lots of cisplatin manufactured in China to be imported. The FDA through Quill Pharmaceutical and Apotex Corp. temporarily allowed the importation of cisplatin after assessing for quality. An official says two manufacturers that had marketed cisplatin and carboplatin also returned to the market.
“Close cooperation among the FDA, the manufacturers, and health care systems is helping to ensure approximately 400,000 patients per month receive their treatments,” the blog states.
The Cancer Moonshot and White House Office of Science and Technology Policy convened a meeting in July with stakeholders, including manufacturers, providers and patient advocates. The administration says they agreed “these supply chain issues cannot be fixed solely through government action” and “that the increased use of data related to supply capabilities and patient needs at a local level can support supply chain resilience and lessen the economic and patient costs of shortages.”
But stakeholders are watching what next steps are taken.
The ASHP recommended enforcing shortage prevention requirements, improving manufacturer quality transparency and encouraging new manufacturers.
“Where cisplatin purchases may be equal to where they were before the shortage. But that doesn't mean use is equal to where it was. And what I mean by that is through these imported products, hospitals and other clinicians may be able to buy as much as they had, but not knowing how long is this going to last They're keeping measures in place to conserve product,” said Michael Ganio, senior director of pharmacy practice and quality with ASHP.
According to the ASHP, which tracks drug shortages, as of the end of June there was a near ten-year high of shortages.
“So we're in really bad shape as far as our hospitals and our clinicians being able to take care of our patients. Fortunately, these aren't new, so our clinicians and pharmacists have found ways to manage drug shortages and make sure patients still receive optimal care. But as the shortages get worse, and they're more prolonged, it makes it more difficult to provide that optimal care to patients,” said Ganio.
Ganio points to longer term needs of creating a rotating buffer supply, similar to a national stockpile of drugs, and providing purchasers with more information regarding manufacturer quality.
The Association for Clinical Oncology said in a July letter to members of Congress that the drug shortages are among the worst seen in decades.
”These shortages are caused by a multitude of factors, including quality issues, manufacturer business decisions, disruptions to raw ingredients and excipient supplies, natural disasters, and other emergencies that take place in countries that house critical drug manufacturing facilities.”
The FDA has faced pressure from congressional members to work with Congress to address the shortages and supply chain issues. A June letter from a bipartisan delegation highlighted FDA authority to monitor drug shortages but states “It is our understanding, however, that many manufacturers are currently non-compliant with these guidelines. We also understand that neither the federal government nor industry has end-to-end visibility into the pharmaceutical supply chain. Together, we believe these factors may limit the federal government’s ability to proactively identify and mitigate drug shortages.”
Congressional members have introduced a slew of proposals to address the issue.
Sen. Gary Peters, a Democrat from Michigan, and Sen. Joni Ernst, a Republican from Iowa, introduced the Pharmaceutical Supply Chain Risk Assessment Act that would require agencies to assess supply chain vulnerability and find ways to lessen reliance on other countries. Another bill, the Drug Shortage Prevention Act, from Senator Amy Klobuchar, Susan Collins, Tina Smith, Lisa Murkowski and Elizabeth Warren would require manufacturers to notify the FDA when they may not be able to meet demand without shortfall or delay.
Officials are in contact with congressional members, according to an administration official.
Thursday, the House Energy and Commerce Subcommittee on Health will hold a hearing on five legislative proposals addressing generic drug shortages.
“We're seeing drug shortages, not just in cancer care, but also ADHD meds, we've been seeing it with opioid medications. We've been seeing it with medications for anesthesia. So this is a very big problem across the board. I think that we really need to focus on how we can prevent this because this impacts so many of us across the country, it is something that we all need to care about, because it's definitely impacting someone you know, whether they talk to you about it or not,” Jain said.
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