U.S. Drug Supply Chain Under Strain Due to Shortage of Chemo Drugs

US: Advocacy groups and lawmakers are calling for the strengthening of the U.S. drug supply chain as a critical shortage of chemotherapy drugs persists. The heavy reliance on a few manufacturers exacerbates the issue, leading to a scarcity of cancer drugs, including cisplatin and carboplatin. Medical practitioners are resorting to rationing care due to the shortage, leaving oncologists.

Recently, the FDA granted temporary authorization for the importation of a non-FDA-approved version of cisplatin from a Chinese manufacturer. For several months, there has been a shortage of Cisplatin, a generic drug that has been available in the US for decades. This is due to an Indian pharmaceutical company halting production temporarily for the US market since February. Cisplatin and other platinum-based drugs are prescribed to 10-20% of all cancer patients. Cisplatin boasts a cure rate of over 90% when treating testicular cancer and is also used to treat bladder, cervical, ovarian, lung, gastric, breast, and head and neck cancers.

While this move has provided some relief in certain areas, clinics that previously switched patients to other platinum-based treatments are now facing shortages. As a result, they are resorting to a precarious game of pharmaceutical patchwork.

The reason behind the shortage of drugs that treat nearly 500,000 new cancer patients every year is due to the dependence on a handful of manufacturers. Any disruption such as plant closure or quality concerns can trigger a chain reaction leading to scarcity.

Karen Knudsen, CEO of the American Cancer Society expressed disbelief over the shortage of cisplatin and carboplatin, which cost $15 and $23 per unit respectively. She highlighted that despite their criticality as lifesaving front-line treatments, these drugs cannot be delivered to patients due to the scarcity.

There is a heated discussion in Congress regarding the recent shortages of drugs, which has sparked a debate on expanding FDA's authority over the drug supply chain. The lawmakers are divided over whether to grant the FDA more regulatory power through the planned reauthorization of pandemic preparedness legislation.

Republican lawmakers, including Cathy McMorris Rodgers of Washington, who serves as the chair of the House Energy and Commerce Committee, and Sen. Mike Crapo of Idaho, the ranking member of the Senate Finance Committee, have called for an investigation into the drug shortage crisis. They aim to explore potential solutions to the issue, while also questioning the role of the Inflation Reduction Act. The act allows Medicare negotiation to reduce drug costs, but it has faced opposition from the drug industry and may be contributing to the problem.