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Pink Sheet — Cancer Drug ‘Strategic Reserve’ May Be Shortage Solution, US FDA’s Pazdur Says

Pink Sheet — Cancer Drug ‘Strategic Reserve’ May Be Shortage Solution, US FDA’s Pazdur Says

An oncology drug “strategic reserve” could be a long-term solution to chronic shortages of critical cancer medicines in the US, FDA Oncology Center of Excellence Director Richard Pazdur suggested during a Friends of Cancer Research workshop last month.

While carefully noting that he cannot advocate for legislative changes, Pazdur described the stockpile as an idea that the “oncology community in general has favored.”

A stockpile would assure a back-up supply of cancer medicines in the event of a shortage, which Pazdur argues also could play a significant role in addressing the economic factors that underpin many of the most critical supply issues.

Drug Shortage Staff Associate Director Val Jensen cited those economic factors as a key issue in the current shortage of three critical medicines (cisplatin, carboplatin and methotrexate) triggered by a production shutdown at the Indian firm Intas Pharmaceuticals Ltd. resulting from quality problems found by the FDA.  (Also see “US FDA Finds Poor Data Integrity At Second Intas Plant” – Pink Sheet, 7 Jul, 2023.)

Jensen suggested a lack of investment in quality explains the problems at Intas and also pointedly noted that the FDA did not ask or want the plant to shut down after the inspection.

“It’s an economic issue,” she said. “Older drugs, they are not profitable. They get discontinued for newer products. There’s a lack of incentive for companies to not only continue to make them but also to invest in quality.”

Jensen then raised the idea of having a “rotating stockpile” as a potential solution and Pazdur jumped in to suggest the phrase “strategic reserve” as a better term, and argued that it should on treated like reserves of critical medicines for potential pandemic or bioterror responses.

While shortages occur across many generic product classes, they are particularly critical in oncology where generic medicines are often still the backbone of treatment regimens even when newer therapies enter the market, Pazdur said.

“Even though many of these drugs are older, they are still commonly used,” Pazdur added. In “some other therapeutic areas, when an innovator drug comes out, some of the older drugs just fall by the wayside and are not used.” In oncology, however, “cisplatin and carboplatin are backbones of testicular cancer therapies, of ovarian cancer, lung cancer therapies, head and neck, so a wide range of diseases.”

“When people take a look at the generic industry, these drugs are commodities, basically,” Pazdur noted. “It is really a race to the bottom of what is the cheapest price of the drug. When you are looking at that type of competitive pricing situation, this does not lend itself to quality manufacturing. Somebody was telling me that people spend more on a McDonald’s dinner for their family than for cisplatin, for example.”

A national “strategic reserve” could “have the effect of establishing a floor price, rather than just going down to the absolute lowest price, and ensure that we don’t run into this problem,” Pazdur suggested. “As with every other reserve, whether it be oil, whether it be any other drug that we’re talking about, stock would be rotated through, so there would not be drug wastage.”

The FOCR event focused on a project to develop circulating tumor DNA as a potential endpoint for cancer drug development. Pazdur focused his comments on other OCE work, including a new pilot program intended to offer an alternative pathway to co-development of lab tests to support targeted medicines.  (Also see “US FDA’s Cancer Drug/Diagnostic Pilot Program Aims To Close The Gap Between Regulation And Clinical Practice” – Pink Sheet, 13 Jul, 2023.)

The discussion of shortages also reflects the broader political interest in addressing the issue. Republicans in the House have declared their intent to draft a bill that addresses the issue beyond FDA’s regulatory mission.  (Also see “House Republicans: Drug Shortage Solutions Must Move Beyond FDA” – Pink Sheet, 13 Jul, 2023.)

The “strategic reserve” idea could fit into that broader push. However, any attempt to build a stockpile will not address the current shortage situation. As a more immediate solution, Jensen told FOCR that the agency was about to clear for import additional quantities of Qilu Pharmaceutical Co., Ltd.’s cisplatin (distributed by Apotex Inc. in the US).  (Also see “The Quality Lowdown: As Washington Churns On Drug Shortages, Supply Chain Challenges Grow” – Pink Sheet, 4 Jul, 2023.)

In addition, the FDA is working with manufacturers who previously discontinued generic oncologic products and “we will have some additional suppliers coming back in,” Jensen said.

“We do expect the supply to continue to improve over the coming weeks for all three of those drugs,” she added.