CNN
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As the United States faces near-record drug shortages, cancer treatments are among the hardest hit.
There are active shortages of about two dozen chemotherapy drugs, the fifth most of any drug category, according to data since late March from the University of Utah Drug Information Service.
“The fact that we have so many chemotherapy drugs in short supply is really concerning,” said Michael Ganio, senior director of pharmacy practice and quality for the American Society of Health System Pharmacists.
Unlike other drugs that are also in the top five categories of shortages, such as antimicrobials, there are often no alternatives to chemotherapy drugs, he said. And the shortage is affecting the treatment of a wide range of cancers.
“One of the key predictors of how well a patient will respond to treatment is receiving a full dose at the correct time,” Ganio said. “So when we can’t deliver the drug because we just can’t get it, that’s heartbreaking.”
Overall, data from the University of Utah shows there were more than 300 drugs in active shortages in the US at the end of March, including nearly 50 new shortages that built up in the first three months of the year.
The last time active drug shortages, including recent and ongoing reports, were this high was 2014, the data shows.
“Shortages keep happening and they don’t get resolved, or they don’t get resolved as quickly as new shortages start,” Ganio said.
On Thursday, the US House of Representatives Subcommittee on Supervision and Investigations on Energy and Commerce held a hearing to explore the root causes of these shortages.
Increased demand is part of it. But experts say some high-profile shortages, like amoxicillin during the most recent season of respiratory viruses and Adderall for ADHD, are the exception.
“They don’t really tell the story of drug shortages,” Ganio said.
Instead, the hearing focused more on manufacturing issues and the broader structure of the US drug market.
The US Food and Drug Administration, in particular, was criticized for falling behind on inspections, especially of international facilities that account for more than half of the manufacturers supplying the US.
TO report of the Government Accountability Office, a federal watchdog agency, in January 2022 noted the “longstanding challenges” facing the FDA’s Foreign Inspection Program and called for more formal steps to improve it.
Effective inspections of domestic and foreign manufacturing facilities are “absolutely essential to ensure the quality and safety of the drugs consumed by American citizens,” said Anthony Sardella, president of the API Innovation Center, a nonprofit focused on in building the US supply. manufactured pharmaceuticals.
“They are also extremely important to ensure market stability,” said Sardella, who was a witness at the hearing.
But at a hearing Thursday by the Subcommittee on Health and Energy and Commerce, FDA Commissioner Dr. Robert Califf said the economic problems underlying drug shortages “are not within the purview of the FDA.”
The FDA is “plugging holes in the levee,” he said, but it’s hard to motivate change when it’s not profitable for drug companies.
“These drug shortages are becoming more prevalent because of a distorted marketplace,” said Rep. Kathy Castor, D-Fla., a ranking member of the subcommittee.
“The current haphazard approach of tackling the crisis episode by episode is not working to give American families the certainty and quality of care they need and deserve.”
Hundreds of looming shortages are looming, and Califf called on drug companies to alert the FDA about it.
“Each company doesn’t know what the other company is doing because they are competing,” he said. “When there is a shortage in a company, we must be able to coordinate among these people.”
Outside of the FDA, there is a small team of White House officials focused on bolstering drug supply chains and quality, a senior administration official confirmed to CNN. The team was first reported by Bloomberg News.
The team, the senior official said, has been “meeting for some time” and is made up of “various” White House offices, including the National Policy Council and the National Economic Council.
“The Biden-Harris Administration remains focused on strengthening the resiliency of critical supply chains, including for medical products like pharmaceuticals,” the official said, pointing to five executive orders issued by President Joe Biden since he took office aimed at of “[catalyzing] whole-of-government action toward these goals.”
Blame aside, patients remain at the center of the problem.
“Every day there is a serious impact on patients,” said Laura Bray, founder of Angels for Change, an advocacy group focused on ending drug shortages. “We also can’t forget the emotional trauma you’re causing a family in medical crisis.”
She experienced it firsthand in 2019 when her 9-year-old daughter Abby couldn’t get the medicine she needed to treat her leukemia because there was a shortage.
Abby is doing well now, but 9 out of 10 oncologists say drug shortages have led to harm to patients, including death, said Bray, who was a witness at the Oversight hearing on Thursday.
“Patients deserve to have access to these medicines. The doctors, nurses, and care team who are trying to solve these crises and save them deserve easy and equitable access to these medicines.”
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