Drug shortages in the United States are nearing record levels, with thousands of patients facing delayed treatment for cancer and other life-threatening illnesses.
Hospitals scour the shelves for drugs to cure lead poisoning and for the sterile liquid needed to stop the heart in bypass surgery. Even after the winter flu season is over and doctors and patients desperately search for treatments for ailments such as strep throat, some antibiotics are still in short supply. Even children’s Tylenol was hard to find.
Hundreds of drugs are on the list of drugs in short supply in the United States, with officials grappling with opaque and sometimes disrupted supply chain, quality and financial issues that have led to production shutdowns.
The shortage is so severe that it has attracted the attention of the White House and Congress, which are investigating the root causes of the sluggish generic drug market, which accounts for about 90% of domestic prescriptions.
With the United States still heavily dependent on drugs and pharmaceutical ingredients from India and China, the Biden administration assembled a team to find long-term solutions to strengthen the drug supply chain. And in recent weeks, generic drug makers, supply chain experts and patient advocates have appeared before lawmakers to debate the issue.
The lack of generic chemotherapy to treat lung, breast, bladder and ovarian cancers only increases concerns.
“In my opinion, this is a public health emergency,” said Dr. Amanda Fader, professor of medicine at Johns Hopkins University and president-elect of the Society of Gynecologic Oncology. Find out how many chemotherapy drugs are currently in short supply. ”
The American Cancer Society warned last week that delays caused by shortages could worsen patient outcomes.
“Without access to these drugs, people will be treated poorly,” said Dr. William Dahat, the association’s chief medical officer. “That’s the bottom line. These aren’t third-line or fourth-line drugs where there are multiple other drugs. They’re used upfront on the people you’re trying to treat.”
Ryan Dowers beat pancreatic cancer in 2021, but a scan late last year revealed cancerous patches on his liver. Dowers, 39 and a father of two young children, had hoped to undergo his final four rounds of chemotherapy in April.
His doctor then gave him startling news. He was not prioritized for treatment.
“We’ve seen the light at the end of the tunnel,” said Dowers, a special education teacher in the city of Iowa. “This proximity made things worse, but now it’s like this.”
Laura Bley, founder of the non-profit organization Angels for Change, works as a liaison between patients, healthcare systems and pharmaceutical companies to “microsource” what she calls hard-to-find medicines. ing.
“Do we have the resolve and the sense of urgency to solve this problem?” asked Bray, an adjunct professor of business who has informed the White House and Congress. “It can be done. It can be done. The same thing happens in other supply chains. I think we’re making judgments about it.”
For Dowers, Bray contacted the manufacturer of the chemotherapy drug he needed, cisplatin, and arranged for supplies to be sent within days and to other patients at the hospital. Some states across the country are not so lucky and encounter a terrifying gap between treatment and treatment.
FDA spokesman James McKinney said the White House team grappling with the broader problem of longstanding drug supply disruptions includes national security, economic and health officials.bloomberg previously reported About White House involvement.
Officials have debated possible measures, including tax incentives for generic drug makers and greater transparency about the quality of generic drugs. Current incentives favor drug companies with the lowest prices, some of which may cut corners, leading to disruptive factory closures if the FDA demands a fix. . (Some shortages, such as weight-loss drugs, are due to surging demand, while others are thought to be due to overprescription, such as antibiotics, and underinvestment in potential alternatives. )
The FDA, which employs a team of about 10 people on a daily basis to mitigate and report drug shortages, said it is asking Congress for authority to obtain additional information about drug manufacturing and supply chains.
But the agency has also raised concerns with the White House about the serious financial strain on the generic drug industry, which FDA officials say is ill-suited to deal with.
FDA Commissioner Dr. Robert Calif emphasized the FDA’s position at a recent Congressional meeting, saying there are too many holes for the agency to fill.
Dr. Caliph told a House of Representatives committee on May 11 that “to solve this situation, we need to revise the core economics.”
David Goh, interim chief executive of the Accessible Medicines Association, which represents generic drug makers, told FDA officials at an April meeting that the recent bankruptcy and closure of Acorn Pharmaceuticals could follow. I remembered warning you that .
“There are more shortages. We’ve all seen that,” Goh said in an interview. “And the situation is likely to get worse, not better, in the near term.”
Goh cited data highlighting the pressures facing the generics industry. Although the number of generic drug makers is increasing, the market is consolidating, with three buyers accounting for about 90% of generic drug purchases, according to research by healthcare analytics firm IQVIA. Intermediaries are a combination of major drug distributors and retail chains, including Red Oak Sourcing, which includes CVS Health and Cardinal Health, and ClarusONE, which includes Walmart and McKesson. Walgreens also has a distribution deal with AmerisourceBergen. Both companies did not respond to requests for comment.
In the race for contracts with these intermediaries, U.S. manufacturers are competing with Indian manufacturers whose labor costs are much lower. When generic drug companies fail to win contracts for a drug, they tend to stop manufacturing that drug, which can erode their already meager profits.
“Generic drug makers have a much smaller chance of making a mistake,” says Goh.
Hospital pharmacists and supply chain experts were appalled by Acorn’s sudden closure in February. Acorn’s products were then recalled because there was no staff left to address potential quality concerns.
Eric Tichy, chairman of the supply chain division at the Mayo Clinic and president of the Alliance to End Drug Shortages, said this added “an insult to injury.”
Acorn made about 100 medicines, including albuterol cylinders that children’s hospitals relied on to ease breathing difficulties. And it was the only company to produce an antidote for lead poisoning, Dr. Tichy said.
“Health is very foundational for our country to function well,” said Dr Tichy. “Since then, some domestic manufacturers have just gone bankrupt, so there hasn’t been much action.”
Four Senate bills with bipartisan support could help bring generic drugs to market faster by addressing tactics and loopholes that cause delays.while at home hearing About the shortage, Anthony Saardera, a business research adviser at the University of Washington in St. Louis, said Thursday that prices for generic drugs have fallen about 50% since 2016.
“But with low prices comes high costs,” said Sardera, noting that cutting costs can lead to quality problems.
A recent case in point is Intus Pharmaceuticals, an Indian company that manufactures three major chemotherapy drugs that are hard to come by: methotrexate, carboplatin, and cisplatin, which Mr. Dowers needed. Insta suspended production of the drug after the FDA found a serious quality control violation.
FDA inspectors reportedly found a “truck loaded with hundreds of plastic bags” filled with torn and shredded documents during an unannounced visit to the Intus plant. Report published in December. According to the report, one of the quality control officers doused the torn record with acid and stuffed it in a garbage bag.
According to the report, FDA inspectors pieced together the documents and found quality control records for products destined for the United States. The agency also raised a number of other issues.
To ease supply disruptions, Intus’ U.S. distributor Accord Pharmaceuticals said a small number of lots had been tested and certified by a third party before being released to the U.S. market. Among them was a treatment arranged by Bray, which was delivered to a patient in Iowa.
Accord said in a statement that the two companies are working with the FDA to resume manufacturing for U.S. customers, adding that the shredding turned out to be a “separate incident.”
The Society of Gynecologic Oncology conducted a national survey in recent weeks. In response, doctors in 35 states said even large cancer centers and teaching hospitals had little or no supply of key chemotherapy drugs.
Patrick Timmins, M.D., partner at Women’s Cancer Care Associates in Albany, N.Y., said the clinic ran out of some chemotherapy drugs on May 9, but still has 25 patients in need. Stated.
“Our patients are at war and what we are doing is disarming them,” Dr. Timmins said. “It’s just ridiculous that we can’t find a way to treat patients, at least in the short term, and solve these recurring problems in the long term.”
When Mr. Bray met with White House officials in late April, he said he recommended creating exchanges to make medicines available where they were needed most, and increasing production of small quantities of medicines, often called concoctions. .
Kevin Shulman, a Stanford University School of Medicine professor who studies the generic drug industry, said he has asked a White House team to investigate how much power intermediaries have in contracts with generic drug makers. . They demand the lowest prices, he said, but unlike customer-facing companies like Apple that contract with suppliers around the world, drug brokers don’t take any responsibility for shortages. said no.
Shulman said he recommended the government expand government contracts with nonprofit Civica, which sells generic drugs at a slightly premium price, which would help generic drug makers to operate stably. .
“Middlemen are driving people out of the market,” Dr. Shulman said. “I think this is a market problem. We need a market-level solution.”