The Biden administration on Monday announced the key chemotherapy drug, cisplatin, is back to “nearly 100% of pre-shortage levels,” according to a memo first obtained by Scripps News.
While the administration says progress is being made in addressing cancer drug shortages across the country, it acknowledged that more needs to be done to ensure patients receive critical care.
Medical organizations warned over the summer about the impact of delayed treatments due to shortages of 15 cancer drugs, including three widely used generic drugs – cisplatin, carboplatin and methotrexate. However, even though the White House has highlighted strengthening the supply chain, shortages of those three drugs persist, according to the Food and Drug Administration’s website. They are part of a widespread ongoing drug shortage, including many generic drugs.
In June, the FDA announced it would allow the importation of cisplatin to help reduce the strain. An FDA official said the agency continues to consider temporary importation of the 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 it will take That they are helping strengthen the supply chain for widely used cancer drugs.
In a summer survey released in July, more than half of respondents said the shortage of chemotherapy drugs was “severely impactful”. ASHP Drug Shortage Resource Center With data from the University of Utah Drug Information Service, that means rationing, canceling or delaying cancer treatment is necessary. Meanwhile, the National Comprehensive Cancer Network found that of its 27 member institutions that participated in the survey, 93% experienced carboplatin and 70% cisplatin shortages, and while some institutions were able to continue treating patients, 16% Reported delay in treatment.
“Ensuring that every American has access to the tools and interventions available today to prevent, detect, and treat cancer – and the progress we are making in the Biden-Harris Administration – Biden’s Cancer Moonshot to End Cancer necessary to achieve the goal. We know this,’ says a new blog post from the White House Office of Science and Technology Policy.
Advancing the fight against cancer and strengthening the supply chain have been key pillars of Biden’s agenda.
“The cisplatin shortage over the last year and a half has impacted the oncology community in a big way,” Dr. Shikha Jain, associate professor of medicine at the University of Illinois Cancer Center, told Scripps News. “Although it seems to be improving, shortages of other chemotherapy drugs are still seriously affecting cancer patients.”
Jain pointed to the lack of 5-FU (5-fluorouracil), which is a chemotherapy drug and is first-line for most gastrointestinal cancers.
“It’s a balancing act between which drugs we have and which we don’t,” he said.
The administration points to manufacturing and supply chain issues in the drug shortage, including products being discontinued over time for economic reasons and manufacturing site closures that have cut the supply of three generic drugs by nearly half this year. The FDA had previously found significant violations at a manufacturer’s plant in India. According to an FDA official, the company that uses the product has indicated that it has begun releasing inventory again after pausing distribution.
The FDA said it “recognizes the potential impact that lack of availability of certain products could have on health care providers and patients. However, the agency does not manufacture drugs and does not allow any drug company to make a drug, make more of a drug, or While drug distribution may not need to be changed, the public should rest assured that the FDA is working closely with multiple manufacturers and others in the supply chain to understand the impact of intermittent or reduced availability of certain products, including reduced Series to do and stop or reduce.
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 has worked with manufacturers of generic methotrexate for injection to increase supply. Have also worked. According to the blog post, the actions have helped bring cisplatin supply to nearly 100% of pre-shortage levels and are helping to offset the carboplatin shortage.
The actions included the FDA granting permission to import 14 lots of cisplatin manufactured in China. The FDA temporarily allowed the import of cisplatin through Quill Pharmaceutical and Apotex Corp after assessing the quality. An official says two manufacturers marketing cisplatin and carboplatin also returned to the market.
“Close collaboration between the FDA, manufacturers, and health care systems is helping to ensure that approximately 400,000 patients per month receive their treatment,” the blog said.
Cancer Moonshot and the 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 agree that “these supply chain issues cannot be fixed through government action alone” and “increased use of data related to supply capabilities and patient needs at the local level across the supply chain.” Can support flexibility and reduce economic and patient costs” shortage.
But stakeholders are keeping an eye on what next steps are taken.
ASHP Recommended Enforcing shortage prevention requirements, improving manufacturer quality transparency, and encouraging new manufacturers.
“Where cisplatin purchases can be equal to where they were before the shortage. But that doesn’t mean usage is the same as it was. And what I mean to say is that through these imported products, hospitals and other physicians can buy as much as they had, but not knowing how long it will last, they are taking measures to preserve the product. “There are,” said Michael Ganio, senior director of pharmacy practice and quality at ASHP.
According to ASHP, which tracks drug shortages, the shortage was at its highest level in nearly ten years by the end of June.
“So as far as our hospitals and our physicians are able to take care of our patients, we’re in really bad shape. Fortunately, these are not new, so our physicians and pharmacists have found ways to manage drug shortages and ensure that patients still receive optimal care. But as shortages increase and persist longer, it becomes more difficult to provide optimal care to patients,” Ganio said.
Ganio points to long-term needs to create a rotating buffer supply similar to a national stockpile of drugs and to provide buyers with more information about manufacturer quality.
The Association for Clinical Oncology said in a letter to members of Congress in July that the drug shortage is one of the worst in decades.
“These shortages are caused by a number of factors, including quality issues, manufacturer business decisions, disruptions in raw material and excipient supplies, natural disasters and other emergencies occurring in countries with critical pharmaceutical manufacturing facilities.”
The FDA has faced pressure from members of Congress to work with Congress to address shortages and supply chain issues. a june letter A bipartisan delegation highlighted FDA authority to monitor drug shortages, but said, “However, it is our understanding that many manufacturers are not currently complying with these guidelines. We also understand that neither the federal Neither the government nor the industry has end-to-end visibility into the pharmaceutical supply chain. Together, we believe these factors limit the federal government’s ability to proactively identify and mitigate drug shortages. can do.
Members of Congress have introduced several proposals to address this issue.
The resolution was introduced by Democratic Senator Gary Peters of Michigan and Republican Senator Joni Ernst of Iowa. Pharmaceutical Supply Chain Risk Assessment Act This will require agencies to assess supply chain vulnerabilities and find ways to reduce dependence on other countries. Another bill, Drug Shortage Prevention ActSenators Amy Klobuchar, Susan Collins, Tina Smith, Lisa Murkowski and Elizabeth Warren would require manufacturers to notify the FDA when they may no longer be able to meet demand without shortages or delays.
According to an administration official, officials are in touch with Congress members.
On Thursday, the House Energy and Commerce Subcommittee on Health will hear five legislative proposals addressing generic drug shortages.
“We are seeing drug shortages, not only in cancer care, but also in ADHD medications, we are seeing it with opioid medications. We are seeing this with anesthesia drugs. So this is a huge problem across the board. I think we really need to focus on how we can stop this because it affects so many of us across the country, it’s something we all need to focus on. Is, because it is definitely affecting anyone you know, no matter how they talk to you. It is there or not,” Jain said.