Here's why there is a record critical drug shortage in the US

Here’s why there is a record critical drug shortage in the US

US Senate discussed drug shortages endangering patients' health
End of 2022 marked a five-year high with 295 reported active shortages
Thin profit margins and outsourcing production are contributing to the issue

Updated: Dec 9, 2023 / 08:07 PM CST

FILE – Adderall XR capsules are displayed on Feb. 24, 2023. Drug shortages are growing in the United States, and experts see no clear path to resolving them. The U.S. Food and Drug Administration announced last fall a shortage of the attention deficit/hyperactivity disorder treatment Adderall due to a manufacturing problem. (AP Photo/Jenny Kane, File)

(NewsNation) — The U.S. Senate Committee on Finance delved into the persistent shortages of crucial drugs that are jeopardizing the well-being of patients across the nation, both physically and mentally, in a hearing on Tuesday.

“The absence of a generic and cheap drug like fludarabine literally can be the difference between life and death,” Dr. Jason Westin, director of the Lymphoma Clinical Research program at M.D. Anderson Cancer Center told the committee.

The end of 2022 marked a five-year high with 295 reported active shortages, and a Senate report revealed over 15 drugs enduring shortages for more than a decade, in stark contrast to the average duration of 1.5 years.

Sen. Mike Crapo underscored a concerning statistic: out of nearly 200 ongoing drug shortages, 84% pertained to generic drugs, not innovative medicines. These generics constitute 90% of all prescriptions filled in the US, amplifying the crisis’s impact on the healthcare system.

Among the generic drugs in short supply, cancer treatment faces a severe setback, with fludarabine, a key component of CAR T-cell therapy, currently unavailable according to the U.S. Food and Drug Administration.

Shortages of cancer drugs are causing doctors to make difficult decisions about patient care, including rationing doses and opting for alternate treatment options with more possible side effects.

A major contributor to the problem is the thin profit margins of generic drugs, dissuading companies from producing them. And the outsourcing of generic manufacturing to countries like China and India poses both geopolitical and quality-control challenges.

Addressing potential solutions, experts proposed implementing value-based payments to incentivize bulk buyers like pharmacies and hospital systems to choose manufacturers with reliable supply chains. Currently, buyers only consider price since generic drug makers aren’t required to disclose supply chain information.

For a comprehensive resolution, the Centers for Medicare & Medicaid Services, the nation’s largest drug purchaser, must shift from price-based purchasing to quality and reliability-based procurement, according to Dr. Marta E. Wosińska, an economist and senior fellow at the Brookings Institution.

Testifying experts also highlighted the consolidation of generic drug purchasing among a few powerful intermediaries, such as drug wholesalers and pharmacy benefit managers (PBMs).

Sen. Ron Wyden expressed concern over the disproportionate profits going to middlemen rather than manufacturers. The Senate is currently considering legislation to combat unfair practices, such as “spread pricing,” where PBMs charge more to payers than they reimburse pharmacies, pocketing the difference.

A recent survey by the American Cancer Society disclosed that one in 10 patients has already felt the brunt of drug shortages, resorting to substitute medications or facing treatment delays.