If you put the federal government in charge of the Sahara Desert, in 5 years there'd be a shortage of sand.
Milton Friedman in 1980
PETERS, STABENOW & SLOTKIN CALL ON FDA TO TAKE ALL POSSIBLE ACTIONS TO MITIGATE CANCER DRUG SHORTAGESWASHINGTON, DC – U.S. Senators Gary Peters (MI), Chairman of the Homeland Security and Governmental Affairs Committee, and Debbie Stabenow (MI), along with U.S. Representative Elissa Slotkin (MI-07), wrote to Dr. Robert Califf, the U.S. Food and Drug Administration (FDA) Commissioner to ask that the FDA do everything in its power to mitigate the dire shortage of cancer drugs that has reached crisis levels in recent months. The nationwide shortages of critical cancer drugs, specifically cisplatin and carboplatin, are causing hospitals and health care systems in Michigan and across the country to ration products and delay needed treatments for cancer patients. The letter thanked FDA for their efforts and urged them to take swift action to address these shortages, including by using their authority to allow temporary importation of alternate medications and expediting approvals of potential new manufacturing lines, facilities, or suppliers to increase supply of these critical drugs.
“We are deeply concerned with the worsening shortages of chemotherapy drugs, including cisplatin and carboplatin, and urge the Food and Drug Administration to do everything in its power to alleviate the strain on patients and prevent delays in life-saving treatments,” the lawmakers wrote. “Cisplatin and carboplatin, two critical chemotherapy agents used to treat a wide range of cancers, have been on FDA’s shortage list since February and April of this year. At least 50,000 Americans rely on cisplatin as part of their chemotherapy treatments, as the product is used in approximately 10 to 20 percent of chemotherapeutic regimens.”
“We recognize that this shortage – as with the majority of shortages involving generic drugs – are largely due to a broken economic system in the generic drug industry,” the lawmakers continued. “While Congress is actively working on long-term solutions to this longstanding problem, we ask that in the short-term, FDA utilize all of its existing authorities to mitigate this dire shortage.”
While the COVID-19 pandemic highlighted vulnerabilities in our nation’s medical supply chains, drug shortages are a longstanding problem and for decades, hospitals and health care providers have regularly experienced shortages of medications that are used to provide critical care and treat serious diseases, like cancer. The current shortages of cisplatin and carboplatin have been exacerbated by a disruption in supply from one manufacturer – the India-based Intas Pharmaceuticals Limited – which supplies a significant portion of these drugs to be distributed in the United States. Following this disruption in supply, other manufacturers have been unable to meet the increased demand for these drugs.
This type of supply chain disruption is a common cause of drug shortages. Earlier this year, Peters released a report on his investigation into ongoing shortages of critical medications. His report found that drug shortages are rising due to economic drivers, insufficient visibility into supply chains, increased demand, and our nation’s continued overreliance on both limited numbers of manufacturers and foreign suppliers – including those from China and India – for many of the raw materials used to manufacture critical drugs.
The text of the letter is copied below and available here.
Dear Commissioner Califf:
We are deeply concerned with the worsening shortages of chemotherapy drugs, including cisplatin and carboplatin, and urge the Food and Drug Administration (FDA) to do everything in its power to alleviate the strain on patients and prevent delays in life-saving treatments. We recognize that this shortage—as with the majority of shortages involving generic drugs—are largely due to a broken economic system in the generic drug industry. While Congress is actively working on long-term solutions to this longstanding problem, we ask that in the short-term, FDA utilize all of its existing authorities to mitigate this dire shortage. We know FDA is acutely aware of this issue and appreciate the agency’s tireless work.
Cisplatin and carboplatin, two critical chemotherapy agents used to treat a wide range of cancers, have been on FDA’s shortage list since February (cisplatin) and April (carboplatin) of this year. The per-unit wholesale cost of these two drugs is generally less than a side of fries at McDonalds. At least 50,000 Americans rely on cisplatin as part of their chemotherapy treatments, as the product is used in approximately 10 to 20 percent of chemotherapeutic regimens. In 2022, over 130,000 Americans were diagnosed with a cancer that relies on either cisplatin or carboplatin for treatment. According to the Michigan Health and Hospital Association, these shortages are “forcing Michigan hospitals and health systems to find alternative treatments for patients, some of which may be less effective.” Further reports indicate patients in some cases may have had to postpone life-saving treatments altogether. Even when health care providers can secure supplies, they are often at outrageously inflated prices; one health system reported to us that it has paid 50 times the usual price for a small supply of cisplatin. In addition, hospitals and health care professionals have expressed significant frustration because they have been unable to tell patients why they cannot access the drugs or when they can expect to receive additional supply.
Unfortunately, this situation appears to be a textbook drug shortage. We understand the shortage of cisplatin and carboplatin stemmed from a disruption in supply due to quality control issues at Intas Pharmaceuticals Limited, a manufacturer based in India that supplies product for Accord Healthcare to distribute to the U.S. market. When Accord Healthcare could not continue supplying these products, the remaining manufacturers were unable to keep pace with increased demand. FDA’s website, however, does not list the reason for Accord Healthcare’s shortage, nor does it list Intas Pharmaceuticals Limited as the manufacturer. Instead, FDA’s website states “other,” as the reason for the shortage and notes that cisplatin and carboplatin is “marketed by Accord Healthcare” and “current inventory is being allocated, further availability pending return to manufacturing.” While we understand that certain restrictions prevent FDA from sharing some information publicly, the cause of a drug shortage helps inform provider mitigation strategies and communication with patients.
Strengthening our pharmaceutical supply chain will take sustained effort and investments over time to address the broken economic system. It will also require increased transparency from manufacturers and FDA. Given the acute nature of this shortage and the severe impact a delay in receiving this medication could have on cancer patients, we ask that FDA continue to work as expeditiously as possible and use all existing authorities to increase supply of these critical drugs. Specifically, we urge you to do everything in your authority to increase the availability of supply, including initiating temporary importation of alternate products under FFDCA 801(d)(1)(B) and expediting approvals of new manufacturing lines, facilities, or suppliers to alleviate this crisis.
Thank you for your attention to this important matter.
Not good news for the most unfortunate in Michigan:
Amid cancer drug shortages, some Michigan doctors are forced to ration.
Dr. John Wallbillich in his office
By Robin Erb - May 19, 2023Two cancer drugs have been in short supply nationally for weeks, prompting rationing guidelines.
Several Michigan providers have scaled back doses. At least one reported a patient going without treatment for several days.
Two Michigan medical groups have called for policy changes to address drug shortages.
Countless Michiganders with cancer face critical shortages of two of the most widely used, life-saving drugs.
Amid the nation’s worst drug shortages in years, several Michigan providers have been forced to scale back doses by 10 percent or more. On Friday, the Barbara Ann Karmanos Cancer Institute ran out of carboplatin, one of the two drugs at issue, one doctor told Bridge.
And Henry Ford Health, oncologists, pharmacists and other staff this week conducted daily 7 a.m. meetings to assess ongoing shortages. About 300 patients could be impacted, according to a health system spokesperson.
“This is really unconscionable … that something that's as effective and as well known as carboplatin and cisplatin — and so necessary for cancer patients — could be in shortage for months,” Chu said.
“We are at the point where some places are out of the drug,” said Dr. Emily Mackler, director of the Pharmacists Optimizing Oncology Excellence in Michigan and the Michigan Oncology Quality Consortium -- partnerships of oncologists and of pharmacists specializing in oncology care.
At issue are the chemotherapy drugs carboplatin and cisplatin. Both are part of a class of infusion drugs containing the element platinum, which binds to the DNA of cancer cells and disrupts the cell’s ability to grow. The U.S. Food and Drug Administration alerted providers on Feb. 10 that cisplatin was becoming scarce. On April 28, the administration added carboplatin to its drug shortages list.
The drugs are used to treat multiple cancers, non-small cell lung cancer, head and neck cancer, testicular cancer, thoracic cancer, bladder cancer, and cancer when it’s not clear in what part of the body it started. In children, they are used to treat a type of kidney and a cancer that begins in nerve cells.
They’re especially critical in gynecologic cancers, too.
“They certainly are core drugs for multiple, multiple common cancers,” agreed Dr. William Dahut, chief scientific officer for the American Cancer Society, told Bridge Michigan Thursday.
“The physicians don't have any ability to get the patient the drugs, and there’s no place for the patients to turn because nobody has them,” said Duhat, who, prior to his role at the American Cancer Society, was scientific director for clinical research at the Center for Cancer Research at the National Cancer Institute.
The shortages force providers to use the lowest doses of the drugs possible for patients, stretch out intervals between doses, and - if worse comes to worst, prioritize patients, doctors told Bridge Michigan.
“It's really difficult with carboplatin and cisplatin both being short at the same time, because - in a lot of different (patient) scenarios - one is the alternative for the other,” said Mackler with the oncology care improvement groups.
Mackler and others have been tracking the shortages among Michigan cancer treatment providers.
Without “thoughtful” prioritization of dosing and patients, she said, rationing will happen anyway because the drugs will no longer be available for some patients.
It’s already happened at least once.
One Michigan cancer treatment provider reported to Mackler that it had to delay treatment by four days for a patient, said Mackler, declining to name the provider.
It’s a scenario that may be increasingly likely in the coming weeks, and the importance of the drugs can’t be overstated, providers told Bridge.
“This is cancer. This is not like (delaying) my knee surgery three or four weeks,” said Henry Ford’s Chu.
Carboplatin and cisplatin also are the “backbone” of treatment especially in gynecologic cancers — cervical, ovarian and endometrial cancer, said Dr. John Wallbillich, a Karmanos doctor in Detroit.
He also serves on the legislative and regulatory affairs subcommittee for the Society of Gynecologic Oncology, which last month issued guidelines to providers on how to “allocate the limited supply” for patients who would see “the most significant benefit.”
Doctors should stretch out intervals between treatments whenever possible under the guidelines. If a treatment recommendation calls for infusion every three to four weeks, for example, the doctor should default to a four-week cycle. If guidelines offer a dosing range, they are to give the lower dose.
For patients whose cancers appear resistant to carboplatin and cisplatin, the oncologists’ group recommends the drugs be at least minimized, if not altogether abandoned.
On Friday, Karmanos ran out of carboplatin and was running low on cisplatin, Wallbillich said.
Dr. Youssef Hanna, an independent general oncologist in Port Huron, said doctors periodically face drug shortages, but they usually are brief, and there are alternatives.
“We’ve never had to push back patient treatment because we don't have the drugs,” he said. “We’ve never had to have to do it before - not in 20, 25 years.”
Will inferior cancer drugs fill the gap?
It’s difficult to nail down a single reason for the shortage.
Drug manufacturers have cited an increase in demand. A long-time critic of the drug supply chain, Bloomfield Hills Democrat and U.S. Senator Gary Peters, has cited a lack of manufacturers and overreliance on raw materials from other countries as causes for drug shortages in general.
The American Society of Health-System Pharmacists, which has cited manufacturing delays in the shortage of cancer drugs, specifically, said some of those cancer drugs won’t be available until June or July.
Even if that were sooner, “who wants to promise it until you see that on the shelves?” said Laura Appel, executive vice president of government relations and policy at the Michigan Hospital & Health Association.
The hospital industry group this week called on insurers to suspend “prior authorization” that can delay patient access to alternative drugs, as insurers decide whether to cover those alternative drugs. Additionally, the Michigan State Medical Society asked state lawmakers to pressure federal regulators to address ongoing drug shortages. And Peters, the congressman who released a report on drug shortages in March, told Bridge in an emailed statement that he is “pressing the Food and Drug Administration to take swift action … (and) working on legislation” that would address some of the reasons behind drug shortages.
Meanwhile, the White House has reportedly stepped up focus on drug shortages, too.
For now and for some patients, there may be alternative therapies, albeit likely not as reliable. Some of those chemotherapies were abandoned more than 20 years ago, replaced by carboplatin and cisplatin found to be not only more effective, but also produced fewer side effects, said Karmanos’ Wallbillich.
“It feels like the clock is being set back 25 years,” Wallbillich said.
He and others also told Bridge that it’s not clear what paring back doses or stretching out the times between treatments will mean for long-term survivability.
Unlike a broken bone that may be mended so the patient can return quickly to everyday life, cancer forces “the long game” between and the cancer cells they are designed to kill.
“Will some of these interventions -- where you're reducing the dose, or extending out the timeframe or frequency -- lead to drug resistance?” he said.
‘A nightmare’
Ultimately, doctors may have to prioritize patients for whom the drugs may cure the cancer rather than those for whom the drugs may simply extend life, doctors told Bridge.
“I'm thinking that if I can see a 37-year-old with cervical cancer and give her a lifetime -- that's where we would like to spend that cisplatin,” said Dr. Shitanshu Uppal, clinical associate professor of obstetrics and gynecology at the University of Michigan. He also provides cancer care at Trinity Health Ann Arbor Hospital.
It’s a “nightmare - a nightmare for us and for our patients,” said Hanna in Port Huron.
And it’s maddening, said Uppal.
Building problem
The drug shortage has been an increasing problem for years, and drug shortages are now the highest they’ve been in at least five years. In fact, the FDA lists more than a dozen cancer-treating drugs among its 207 drugs in short supply, as of Friday.
Moreover, the pandemic underscored the lethal implications of short supplies as doctors scrambled at times for masks, ventilators, COVID tests, and lab equipment, he said.
“Three years into the pandemic, and it’s again the supply chain (problem) and we can't figure this out? I mean, what's going on?” Uppal said.
Friedman had it right!
Take away the FDA monopoly, and they'd either shape up, or go out of business.
https://www.aha.org/news/headline/2023-06-02-fda-allow-import-oncology-drug-amid-nationwide-shortage
FDA to allow import of oncology drug amid nationwide shortage
The FDA on June 2 told AHA that is has worked with Qilu Pharmaceuticals and Apotex Corp. to temporarily import cisplatin, a drug used in chemotherapy, after a national shortage. FDA said it is carefully assessing the overseas product for quality to ensure it is safe for U.S. patients. The agency issued a “Dear Health Care Provider” letter with details and updated its drug shortage database with more information.
From China, no less.
So ... what's the real reason US drug manufacturers aren't providing a stable supply?
We have dozens of them in Michigan alone.
What's up with this??
https://www.cnn.com/2023/06/03/health/fda-cisplatin-shortage/index.html
By Katherine Dillinger, CNN Published 9:21 PM EDT, Fri June 2, 2023The US Food and Drug Administration is working with Chinese drugmaker Qilu Pharmaceutical to import the cancer medication cisplatin to boost supply amid an ongoing shortage.
Canadian pharmaceutical company Apotex will distribute the injectable medication in 50-milligram vials on a temporary basis. It will be available for order by health care providers starting Tuesday.
Cisplatin and other platinum-based drugs are prescribed for 10% to 20% of all cancer patients, according to the National Cancer Institute. Cisplatin has a cure rate of over 90% when used to treat testicular cancer. It also treats bladder, cervical, ovarian, lung, gastric, breast, and head and neck cancers.
Cancer treatments are among the hardest-hit as the US faces a near-record number of drug shortages. As of the end of March, about two dozen chemotherapy drugs were in active shortage, the fifth most of any drug category, according to data from the University of Utah Drug Information Service.
At a hearing last month on the shortages, lawmakers criticized the FDA for falling behind on inspections, especially of international facilities. But FDA Commissioner Dr. Robert Califf said that the agency is doing what it can even though the economic issues underlying shortages are not in its purview.
“The FDA recognizes the importance of a stable, safe supply of critical drugs used in oncology, especially those used in potentially curative or life-extending situations,” Califf said on Twitter late Friday. “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.
“In these situations, we very carefully assess product quality and require companies to take certain measures to ensure the products are safe for 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 severe shortage of cisplatin and carboplatin, “the chemotherapy backbone,” is affecting hundreds of thousands of patients across the US, Dr. Amanda Fader, a professor at the Johns Hopkins School of Medicine, said Friday.
“Substitutions are sometimes required,” she said. “And in many cases, these drug substitutions are going to be as effective in terms of the response to the treatment. … However, many of these drugs may carry worse side effect profiles or different dosing schedules that require two to three times longer to administer.”
Imports of foreign medications have helped in similar cases before, Fader said. A decade ago, the FDA allowed foreign companies to import the chemotherapy drug Doxil amid a shortage that lasted over a year. “The drugs do need to pass the same rigorous inspections and requirements as conventionally FDA-approved drugs, so that process does take time,” she noted.
CNN’s Jen Christensen contributed to this report.
Senator Peters, in an April 11, 2023 email:
Friend ––
Hospitals and health care systems in Michigan and across the nation have been impacted by drug shortages, and that probl em is only continuing to grow. No one should have to worry about accessing critical drugs like cancer treatments or common over-the-counter medications , yet shortages are forcing health care providers to substitute less-effective medications or limit doses to treat patients.
Drug shortages have real life impacts on patients and health care providers, and Congress must do more to address the problem. We need to encourage more domestic and diversified production of important medications where possible, expand the number of supp liers of critical materials for drugs, and ensure the federal government has up-to-date information that will help them prevent shortages before they reach a crisis point.
As Chairman of the Homeland Security and Governmental Affairs Committee, I recently released a report that shows how these shortages affect patients’ health and safety and present a significant national security risk. I also held a hearing with health care and supply chain experts to discuss my report and highlight how drug shortages are impacting the health and safety of our communities.
Click here to watch more.My report looked into the causes of drug shortages and what we can do to address this problem. Here are some of the report’s key findings and recommendations:
- Drug shortages can lead to treatment delays, medication errors, and have life threatening impacts on patients.
- Nearly 90% of FDA-registered manufacturing sites that produce ingredients to make generic drugs are located overseas. If the U.S. is unable to get the ingredients and raw materials needed to make these medications from these countries it could result in catastrophic consequences for patients.
- We must invest in domestic advanced manufacturing capabilities for generic drug products that are regularly in shortage to reduce our dependence on foreign and geographically concentrated sources and suppliers.
- The federal government and drug companies lack full visibility into where key ingredients for generic drugs are coming from. We must take steps to collect data on the supply chain to ensure agencies are not in the dark and can predict and work to prevent shortages.
Click here to read the full report.
My report and hearing showed that while drug shortages impact every part of our health care system – they tend to hit smaller, rural hospitals and health care providers the hardest because they often lack the resources needed to monitor and find alternative drug supplies. Shortages are made worse by our over-dependence on foreign suppliers, mostly in India and China, for the key raw materials that make many medications, as well as the limited number and clustered locations of facilities both in the U.S. and overseas that produce critical drugs. If one of these countries stops exporting a certain drug or a facility closes, it could lead to devastating shortages.
I’ll continue working toward bipartisan solutions that will help us take action to address this threat and protect the health and safety of Michiganders.
Thanks for reading,
Gary Peters
United States Senator for Michigan
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