Tyler Patchen

Richard Pazdur, director of the FDA’s Oncology Center of Excellence, attributes the current shortage of two cancer drugs to drug companies that haven’t invested in building out their production capacity.

In an interview with The Cancer Letter, a weekly cancer publication, Pazdur said that the current shortages of cisplatin and carboplatin, a pair of drugs used to treat a wide range of cancer patients, are the result of two problems: manufacturers not investing in enhancing production capacity, and drug companies being dependent on one supplier of raw ingredients. The cisplatin shortage followed an inspection that revealed quality issues at a manufacturing facility, which then led to the shutdown of production. This led to a surge in carboplatin demand, creating a secondary shortage.

The shortages are causing oncologists across the US to ration platinum-based drugs, according to The Cancer Letter.
To restore the supply of cisplatin, the FDA is offering assistance to all manufacturers to help boost production, Pazdur said. The regulator is also looking at “temporary importation” options to dampen the situation and asking manufacturers to give the FDA more data about expiration dates for products that have been distributed.

However, Pazdur noted that the agency’s jurisdiction to manage shortages is limited. Current laws don’t require producers to report an increase in demand, and the FDA cannot tell manufacturers what to make or how much to produce — or control the supply chains for drugs.

Michael Ganio, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists (ASHP), which tracks drug shortages, told Endpoints News in an email that he cannot confirm whether the manufacturers were dependent on a single supplier of materials.

“Half of the US market of cisplatin relied on one manufacturer — that has led to a shortage of cisplatin,” Ganio said. “That same manufacturer was responsible for about 20% of the carboplatin market, which has also been problematic because carboplatin has been one of the alternatives clinicians have sought out to manage the cisplatin shortage.”

Bipartisan lawmakers pressure FDA on common chemotherapies now in shortage
Lawmakers have been trying to make headway with the current cancer shortage. Reps. Debbie Dingell (D-MI) and Tim Walberg (R-MI) last week penned a letter to FDA Commissioner Rob Califf, expressing concerns about the shortages of cisplatin, carboplatin and methotrexate, which is also used to treat cancer. Rep. Frank Pallone (D-NJ) issued a statement, saying his staff was working with the Biden administration and the FDA to address the shortages.