Experts Highlight Critical Dilemmas Faced by Americans amid US Drug Shortages
US drug shortages are endangering lives and forcing difficult decisions for Americans, as highlighted by Dr Jason Westin from the MD Anderson Cancer Center The scarcity of generic cancer drugs has left patients and medical professionals in a dire predicament
Dr. Jason Westin, who heads the Lymphoma Clinical Research program at M.D. Anderson Cancer Center in Houston, frequently sees the life-saving impact of cancer drugs. However, he is distressed by the shortage of generic cancer drugs in the United States, which has resulted in difficult circumstances for both himself and his patients.
"Without access to affordable generics like fludarabine, we are faced with life-and-death situations," Westin shared with the members of the US Senate Committee on Finance during a hearing on Tuesday.
The committee is currently conducting an investigation into the long-standing issue of drug shortages, which is specifically unique to the United States, according to studies.
Multiple senators have reported receiving feedback from their constituents who have been impacted by these shortages, either personally or through patients. Senator Marsha Blackburn pointed out that Vanderbilt's medical center in Nashville has had to allocate over 100 staff members to address and minimize the disruptions caused by these shortages.
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The Tennessee Republican stated on Tuesday that this is an increasingly common issue with our providers. According to Sen. Mike Crapo of Idaho, the majority of the nearly 200 ongoing shortages, which account for 84%, do not involve new or innovative drugs, but rather generics that have been available for decades. With generics making up 9 out of every 10 prescriptions filled in the US, the shortages have a significant impact on the country's health.
"These shortages can have devastating effects on large numbers of Americans," stated Crapo. "On average, each shortage impacts at least 500,000 consumers, leaving them to search for other options or go without treatment."
A number of these generic drugs are used in cancer treatment. The US Food and Drug Administration has reported a current shortage of Fludarabine, a dependable drug used in CAR T-cell therapy. Like many other generic drugs for cancer treatment, it has been in and out of shortage for several years.
For Westin and his team, there is no time to wait for a drug to come back in stock when dealing with patients suffering from rapidly progressing aggressive blood cancers. There is only a narrow window in which they are well enough to receive potentially lifesaving CAR T-cell therapy, which specifically requires fludarabine. Westin emphasized to the committee that there is no alternative.
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"My colleagues have been placed in impossible situations, having to decide which patients should be given priority for potentially life-saving treatment," he stated.
"We are skilled in treating cancer, but the lack of resources leads to difficult decisions," he said. "We possess life-saving drugs, but the scarcity of them poses a threat to life itself."
A major issue with generics is that they yield minimal profits, making them unappealing to pharmaceutical companies. The number of companies leaving the market for these drugs is significantly higher than those entering, with an exceeding rate of 40%, according to Crapo.
Dr. Inmaculada Hernandez, a professor at the Skaggs School of Pharmacy and Pharmaceutical Sciences at the University of California in San Diego, pointed out that the outsourcing of generic manufacturing to countries like China and India raises concerns about geopolitical problems and quality control issues. She emphasized that the heavy reliance on foreign manufacturing for the drug supply chain poses a significant national public health risk.
She suggested that one solution could be for the government to implement value-based payments in order to encourage pharmacies and hospital systems, as large buyers of generics, to procure medicine from manufacturers with more reliable supply chains.
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In order to effectively eliminate shortages, the Centers for Medicare & Medicaid Services, the largest buyer of drugs in the country, should prioritize purchasing based on manufacturing quality and reliability instead of just price, according to Dr. Marta E. Wosińska, an economist and senior fellow at the Brookings Institution.
Dr. Wosińska stated during her testimony on Tuesday that rewarding reliability would encourage manufacturers to maintain a higher price point, incentivizing them to prioritize reliability.
In simple terms, this means that additional companies would enter the generics industry. Experts testified that the government would also need to address the issue of a few influential healthcare intermediaries monopolizing the purchase of generic drugs. Senator Ron Wyden of Oregon stated that the profits from generics are currently going to drug wholesalers and pharmacy benefit managers (PBMs) instead of the manufacturers.
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Wyden pointed out that numerous companies produce generic drugs, but they face tough competition from a small number of powerful intermediaries. According to him, three major drug wholesalers dominate 90% of the country's pharmaceutical market.
Wyden also mentioned that generic drug manufacturers secure contracts from these intermediaries by offering significantly lower prices.
Companies are unable to make sufficient profits to invest in necessary capacity or equipment for producing dependable, high-quality medications due to the exceptionally low prices offered. "Ultimately, this results in a downward price competition for generic drugs, which then causes issues with quality control and the closure of manufacturing facilities," Wyden added.
The "middle men" have faced criticism for increasing drug prices. According to a study published in JAMA, PBMs often overpay pharmacies for generics, up to 10 times the acquisition cost, and then recover the excess through clawbacks instead of passing the savings on to customers. When testifying before the Senate committee, Hernandez reported that 16 of the top 50 generic drugs paid for by Medicare Part D were marked up 1,000% or more. For example, the antipsychotic drug aripiprazole cost 17 cents per tablet for pharmacies, but Rite Aid's pharmacy benefit manager paid $11.70 per tablet, marking up the price by 7,000%.
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Hernandez pointed out that customers often end up paying significantly more than the pharmacy actually paid for the drug, not to mention what the manufacturer received for it. She advocates for increased regulation of PBMs, and mentioned that a bill currently being considered by the Senate would prohibit PBMs from practicing "spread pricing," where they charge payers and health plans more for a prescription drug than what they reimburse the pharmacy and keep the excess for themselves.
The experts, including WosiÅska, agree that they will continue until there is legislation addressing drug shortages. WosiÅska expressed frustration about the largely avoidable nature of these shortages.
