Experts tell Senate committee that U.S. drug shortages are forcing Americans to make impossible choices CNN



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As director of the Lymphoma Clinical Research Program at MD Anderson Cancer Center in Houston, Dr. Jason Westin frequently witnesses the life-saving power of anticancer drugs. But he said he and his patients are in trouble because of frequent shortages of generic cancer drugs in the United States.

Westin told members of the U.S. Senate Finance Committee at a hearing on Tuesday that a lack of generic and cheaper drugs like fludarabine could literally be the difference between life and death.

The committee has been investigating record drug shortages, a problem that has been going on for decades and is unique to the United States, according to research

Several senators said they have heard from constituents who have become sick or injured due to shortages. Senator Marsha Blackburn noted that Vanderbilt Medical Center in Nashville had to devote more than 100 staff members to manage and mitigate disruptions caused by the shortage.

The Tennessee Republican said Tuesday that this situation is becoming increasingly common among our service providers.

Sen. Mike Crapo, R-Idaho, said the majority (84%) of the nearly 200 drugs that continue to be in shortage do not involve new drugs or drugs, but generic versions that have been on the market for decades. In the United States, 9 out of 10 prescription drugs are generic, so shortages have a significant impact on the nation’s health.

Crapo said these shortages could severely harm large numbers of Americans. The average shortage affects at least 500,000 consumers, forcing them to look for viable alternatives or else abandon treatment altogether.

Many of these generic drugs treat cancer. Fludarabine, a reliable drug used in CAR T-cell therapy, is currently in shortage, according to the U.S. Food and Drug Administration. Like many generic drugs used to treat cancer, it has been on and off the list for a few years.

For Westin and his colleagues, patients with rapidly progressing, aggressive blood cancers don’t have time to wait for drugs to come back on the market. They are in good health and have only a short window of time before they can receive potentially life-saving CAR T-cell therapy, which is only available with fludarabine. Westin told the committee there was no choice.

“My colleagues are being forced to make impossible choices, including which patients will be prioritized for potentially curative treatments,” he said.

He added that we know how to treat cancer, but shortages force us to make impossible choices. We have life-saving medicines and we have life-threatening shortages.

A big part of the problem with generic drugs is that they come with razor-thin profit margins, so companies are often not interested in producing generic drugs. Crapo said the number of companies leaving the market making these drugs exceeds the number entering the market by more than 40%.

Dr. Inmaculada Hernandez, professor in the Department of Clinical Pharmacy at the Skaggs School of Pharmacy and Pharmaceutical Sciences, noted that most generic drug manufacturing is outsourced to other countries such as China and India, which can create geopolitical issues and quality control issues. at the University of California, San Diego.

Our pharmaceutical supply chain relies heavily on foreign manufacturing. Hernandez told the committee this is a national public health risk.

One solution, she said, is for the government to use value-based payments to incentivize large buyers of generic drugs, such as pharmacies and hospital systems, to buy from manufacturers with more reliable supply chains.

Generic drug manufacturers do not have to share supply chain information, so buyers currently make choices based solely on price.

To truly end drug shortages, the Centers for Medicare & Medicaid Services, the nation’s largest drug purchaser, must be able to base its manufacturing Purchase for quality and reliability, not just price. Senior fellow at the Brookings Institution.

If we started rewarding reliability, the manufacturer could actually maintain a higher price point because it’s being rewarded, which is reliability. An incentive package will follow, Wojciechka testified Tuesday.

In other words, more companies will enter the generics business.

Sen. Ron Wyden, D-Ore., said experts have testified that another problem the government must overcome is the concentration of generic drug procurement in the hands of a small group of very powerful health care middlemen. Although there is money to be made with generic drugs, the money goes to these middlemen, drug wholesalers and pharmacy benefit managers, or PBMs, rather than to the manufacturers.

Wyden said there are many companies making generic drugs, but they must compete for the attention of highly integrated middlemen. He said that the three major drug wholesalers control 90% of the country’s drug market.

Wyden said generic drug manufacturers who get these middleman contracts do so by offering to get what they pay for.

With prices so low, companies don’t have enough revenue to invest in critical capacity or equipment to produce reliable, high-quality medicines.

So, Wyden said, in effect, price-floor competition for generic drugs can lead to quality control problems and plant closures.

These middlemen have also been criticized for driving up drug prices. In a study published Tuesday in the journal JAMA, Hernandez and her co-authors said that PBMs often pay pharmacies unreasonably high prices for generic drugs, up to 10 times the acquisition cost, and then the PBMs Recover fees through callbacks rather than passing them on to customers.

Hernandez told the Senate committee that of the top 50 generic drugs covered by Medicare Part D, 16 saw price increases of 1,000% or more.Aripiprazole is an antipsychotic drug that sells for an average of 17 cents per pill at pharmacies; ritual aids The pharmacy benefit manager pays $11.70 per pill, a markup of 7,000%.

So they end up paying much more than the pharmacy actually pays for the drug, not to mention what the manufacturer gets, Hernandez said.

Hernandez said she recommended greater oversight of PBMs. Legislation currently before the Senate would make it illegal for PBMs to engage in spread pricing, in which companies charge payers and health plans more for prescription drugs than they reimburse pharmacies, and the PBMs pocket the difference.

Wosciuska and other experts agree that they will continue until some kind of legislation is enacted to address drug shortages.

What’s troubling about these shortages is that they’re largely avoidable, Wojciechka said.

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