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The worrisome shortage of anti-cancer drugs has added to concerns about the troubled generics industry. Congress and the White House are looking for ways to solve widespread supply problems.
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Thousands of patients face delays in treatment for cancer and other life-threatening diseases, and drug shortages in the United States are approaching record levels.
Hospitals are scouring shelves for a drug that reverses lead poisoning and a sterile fluid needed to stop the heart in order to perform bypass surgery. Some antibiotics are still in short supply after the winter flu season, when doctors and patients frantically chased for cures for ailments like strep throat. Tylenol Evenchildren was hard to find.
Hundreds of drugs are on the list of drugs that are in short supply in the United States, such asofficials are concernedwith an opaque and sometimes interrupted supply chain, quality and financial problems that lead to production downtime.
The shortages are so severe that they are attracting the attention of the White House and Congress as they investigate the root causes of the faltering generic drug market, which accounts for about 90 percent of the country's prescriptions.
The Biden administration has assembled a team to find long-term solutions to support the pharmaceutical supply chain at a time when the United States is heavily dependent on drugs and drug ingredients from India and China. And in recent weeks, generic drugmakers, supply chain experts and patient advocates have all appeared before legislators to discuss the issues.
The shortage of generic forms of chemotherapy to treat lung, breast, bladder and ovarian cancers only adds to the concern.
"In my view, this is a public health emergency," said Dr. Amanda Fader, a professor at the Johns Hopkins School of Medicine and president-elect of the Society of Gynecological Oncology, "because of the wide range of influencers and the number of chemotherapeutic agents currently in short supply." .
The American Cancer Society warned last week that delays caused by shortages could result in poorer outcomes for patients.
"If these drugs are not available, people will receive poorer care," said Dr William Dahut, the association's chief medical officer. "This is the basis. These are not third or fourth line drugs where there are many other agents. They are used in advance for the people you are trying to heal.
Ryan Dwars beat pancreatic cancer in 2021, but a scan late last year showed cancerous lesions on his liver. Dwars, 39, a father of two, was hoping to receive his final four doses of chemotherapy in April.
Then his doctor delivered the stunning news: he did not make the cut for those given priority treatment.
“The light at the end of the tunnel was within reach,” said Mr. Dwars, a special education teacher in Iowa City. "Being so close was even worse - and now this."
Laura Bray, who founded a nonprofit called Angels for Change, acts as a liaison between patients, healthcare systems, and pharmaceutical companies for "microsources," as she calls it, hard-to-find drugs.
“Will we have the determination and sense of urgency to fix this?” asked Ms. Bray, an assistant professor of business who provides information to the White House and Congress. "It's possible. It can be done. It's happening in other supply chains. But we need to focus on that and think about ending it - instead of appeasing it. I don't think the jury is in the mood for that.
In the case of Mr Dwars, Ms Bray contacted the manufacturer of cisplatin, the chemotherapy he needed, and arranged for a supply to be shipped within days and for others at his hospital. Some states across the country have not been so lucky, encountering appalling gaps between treatments.
According to James McKinney, spokesman for the Bloomberg Agencypreviously reportedon the involvement of the White House.
Officials debated possible measures, such as tax incentives for generic manufacturers and greater transparency about the quality of generic drugs. Current incentives favor the lowest-priced drugmakers, including those who can cut corners - leading to disruptive factory closures if F.D.A. requests a fix. (Some shortages, such as weight-loss medications, are the result of exorbitant demand, while others have been attributed to over-prescription, including antibiotics, or lack of investment in potential alternatives.)
The FDA, which has a team of about 10 people who do the day-to-day work of mitigating and reporting drug shortages, said it was asking Congress to authorize additional information on the drug's manufacturing and supply chain.
But the agency has also voiced concerns about the White House over the heavy financial strain on the generics industry - an economic problem that the F.D.A. officials say they are unaddressable.
Dr. Robert Califf, FDA Commissioner, emphasized the agency's views in recent speeches before Congress, saying that officials can only plug so many holes.
"We need to fix the basic economy if we're going to fix this situation," Dr. Califf told a House panel on May 11.
David Gaugh, interim chief executive of the Association for Accessible Medicines, which represents generic drug manufacturers, recalled the F.D.A.'s warning. officials at an April meeting that the recent bankruptcy and closure of Akorn Pharmaceuticals was likely to be followed by others.
“Shortages are growing. We've all seen it," Gaugh said in an interview. "And it's likely to get worse soon, not better."
Mr Gaugh cited figures highlighting the pressures the generics industry is facing. While the number of generics manufacturers has increased, a review by IQVIA, a healthcare research firm, found that the market has consolidated such that three buyers account for about 90 percent of generic purchases. Intermediaries include major drug distributors and retail chains such as Red Oak Sourcing, which includes CVS Health and Cardinal Health, and ClarusONE, which includes Walmart and McKesson. Walgreens also has distribution deals with AmerisourceBergen. The companies did not respond to requests for comment.
Competition for contracts with these middlemen pits US producers against producers in India, where labor costs are much lower. When a generic drug company cannot get a contract for a drug, it usually stops making it and may see its already small profits dwindle.
"There's much less room for error if you're a generic manufacturer," Gaugh said.
Hospital pharmacists and supply chain experts were stunned in February by Akorn's sudden closure, whose products were subsequently recalled as there were no more staff to deal with potential quality issues.
This added "insult to injury," said Eric Tichy, Mayo Clinic's supply chain chair and board chairman of the End Drug Shortages Alliance.
Akorn produced about 100 drugs, including albuterol cylinders that children's hospitals relied on to ease breathing difficulties. And it was the only company that created an antidote for lead poisoning, Dr Tichy said.
"Health is the basis for the good functioning of our country," said Dr Tichy. "And then we have a domestic manufacturer that just collapses and there's not much action."
Four Senate bills with bipartisan sponsorship could help bring generic drugs to market faster by addressing tactics or loopholes that cause delays. During Homehearingon shortages on Thursday by Anthony Sardella, a business research adviser at Washington University in St. Louis, said generic drug prices have fallen by about 50 percent since 2016.
"But low prices come at a high cost," Sardella said, noting that they can lead to cost cutting, which can result in quality issues.
A recent example of this was Intas Pharmaceuticals, a company in India that produces three key chemotherapy drugs that are hard to find: methotrexate, carboplatin and cisplatin, a drug Dwars needed. Intas temporarily suspended drug production after F.D.A. found serious quality control violations.
During an unannounced visit to the Intas facility, F.D.A. inspectors discovered a "truck full" of hundreds of plastic bags filled with torn and tattered documentsreport released in December. One of the quality control workers poured acid on the torn records and stuffed them into a garbage bag.
FDA inspectors pieced together papers and found quality control records for products destined for the United States, the report said. The agency also listed a number of other problems.
To ease the supply disruption, Intas' US distributor Accord Pharmaceuticals said several batches have been third-party tested, certified and released to the US market. These included treatments arranged by Ms. Bray that reached patients in Iowa.
The companies cooperated with F.D.A. to resume production for US customers, Accord said in a statement, adding that the destruction was an "isolated incident".
The Society of Gynecological Oncology has sent out a nationwide survey in recent weeks. In response, doctors in 35 states said they had little or no stockpiles of key chemotherapy drugs, even at major cancer centers and teaching hospitals.
Dr. Patrick Timmins, a partner at Women's Cancer Care Associates in Albany, New York, said his office ran out of some chemotherapy drugs on May 9, but still has 25 patients who need them.
"Our patients are at war and we're taking their guns away," Dr Timmins said. "It's completely ridiculous that we can't find a way, at least in the short term, to treat our patients and in the long term to solve these recurring problems."
When Ms Bray met with White House staff in late April, she said she recommended setting up an exchange to get drugs to where they are most needed, and increasing the production of drugs in small batches, often referred to as compounding.
Dr. Kevin Schulman, a Stanford professor of medicine who has studied the generics industry, said he urged the White House team to investigate the power of firms that broker deals with generic drugmakers. He said they demand the lowest prices, but unlike a customer-centric company like Apple that deals with suppliers around the world, drug brokers are not held accountable when shortages occur.
Dr. Schulman said he recommended expanding government contracts with the non-profit Civica, which sells generics at slightly inflated prices, which could help generics makers run a stable business.
"The middlemen are pushing people out of the market," Dr. Schulman said. "I think it's a market problem and we need market-level solutions."
Audio produced by Kate Winslett.
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