CNN
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As the US faces a near-record number of drug shortages, cancer treatment is one of the hardest hit.
According to the data, there is an active shortage of about two dozen chemotherapy drugs, which is the fifth largest among all drug categories. data from the end of March from the University of Utah Drug Information Service.
“The fact that we have so many chemo drugs in short supply is really alarming,” said Michael Ganio, senior director of pharmacy practice and quality for the American Society of Health System Pharmacists.
Unlike some other drugs that are also in the top five shortage categories, such as antimicrobials, there are often no alternatives for chemotherapy drugs, he said. And the shortage affects the treatment of a wide range of cancers.
“One of the key indicators of how well a patient will respond to treatment is getting the full dose on the right schedule,” Ganio said. “So when we can’t give a cure because we just can’t get it, it’s heartbreaking.”
Overall, Utah State University data shows that there were active shortages of more than 300 drugs in the US as of the end of March, including nearly 50 new shortages that had accumulated in the first three months of the year.
The data shows that the last time active drug shortages, including both new and ongoing ones, were this high was in 2014.
“Shortages are still happening and they are not being resolved or are not being resolved as quickly as new shortages start,” Ganio said.
On Thursday, the House Energy and Commerce Subcommittee on Oversight and Investigations held hearings examining the root causes of the shortfall.
The increase in demand is part of this. But experts say some high-profile deficiencies, such as amoxicillin during the most recent respiratory virus season and Adderall for ADHD, are the exception.
“They don’t really tell the story of drug shortages,” Ganio said.
Instead, the hearings focused more on production issues and the broader structure of the US drug market.
In particular, the US Food and Drug Administration has been criticized for lagging behind in inspections, especially of international businesses representing more than half of the manufacturers that ship products to the US.
A report of the Government Accountability Office, the federal oversight body, in January 2022 noted “longstanding challenges” facing the FDA’s Foreign Inspection Program and called for more formal steps to improve it.
Effective audits of both domestic and foreign manufacturing facilities are “absolutely essential to ensure the quality and safety of the drugs US citizens consume,” said Anthony Sardella, chairman of the API Innovation Center, a nonprofit dedicated to expanding the supply of US-made drugs. pharmaceutical preparations.
“They are also extremely important to market stability,” said Sardella, who was a witness at the hearing.
But at a hearing Thursday in the Health and Energy Trade Subcommittee, FDA Commissioner Dr. Robert Kaliff said that the economic problems underlying drug shortages “are not within the purview of the FDA.”
The FDA is “plugging holes in the dam,” he said, but it’s hard to motivate change when it doesn’t benefit drug companies.
“This drug shortage is becoming more widespread due to a distorted market,” said Rep. Kathy Castor, D-Fla., a senior member of the subcommittee.
“The current haphazard approach to crisis management, episode by episode, is not giving American families the confidence and quality of care they need and deserve.”
Hundreds of impending shortages are looming, and Kaliff has urged pharmaceutical companies to alert the FDA about them.
“Each company doesn’t know what the other company is doing because they are competing,” he said. “When one company lacks, we need to be able to coordinate those people.”
In addition to the FDA, there is a small group of officials in the White House dedicated to strengthening drug supply chains and quality, a senior administration official confirmed to CNN. It is reported by Bloomberg News.
The team, according to a senior official, has been “assembling for some time now” and consists of “several” White House offices, including the Domestic Policy Council and the National Economic Council.
“The Biden-Harris administration remains focused on strengthening the resilience of critical supply chains, including for medical products such as pharmaceuticals,” the official said, pointing to five executive orders issued by President Joe Biden since taking office aimed at “[catalyzing] whole-of-government action to achieve these goals”.
Blame aside, patients remain at the center of the problem.
“There is a major impact on patients every day,” said Laura Bray, founder of the Angels of Change, an advocacy group dedicated to ending drug shortages. “We also cannot forget the emotional trauma you are causing to a family in a health crisis.”
She experienced it first hand in 2019 when her 9-year-old daughter Abby was unable to get the medicine she needed to treat her leukemia due to a shortage.
Abby is doing well now, but 9 out of 10 oncologists say the drug shortage has led to patient harm, including death, said Bray, who was a witness at Thursday’s hearing.
“Patients deserve access to these medicines. The doctors, nurses and care team who are trying to solve these crises and save them deserve easy and equal access to these medicines.”
