FDA can't solve drug shortages on its own, agency's oncology chief says

 As oncologists ration critical platinum-based cancer drugs in the U.S., government officials are busy seeking to alleviate the problem. But the government can't do it alone, one leader said.

The FDA has a hand in mitigating cancer drug shortages, but its abilities are limited, the director of the FDA's Oncology Center of Excellence, Richard Pazdur, M.D., told The Cancer Letter.

The root cause of shortages of chemo drugs such as cisplatin and carboplatin is ultimately a failure by the industry to invest in building capacity, Pazdur told the publication. 

With cisplatin specifically, the shortage started at one manufacturing facility after the FDA identified quality issues after an inspection. The plant then had to shut the production line, which triggered a “ripple effect" in the supply chain, according to Pazdur.

The FDA has offered assistance to the five manufacturers that produce the drug and is “exploring temporary importation," but the agency can’t do much to fully alleviate the shortage, Pazdur told The Cancer Letter.

As it stands, the FDA can’t require a company to manufacture a drug, nor can it make a manufacturer report increases in demand that could lead to a shortage, Pazdur explained. It also can’t require that essential drugs, including chemo, have diversified supply chains.

Even for drugs with more than one manufacturer, most facilities are operating near capacity. This means they aren't able to provide extra supplies if another plant stops production, Pazdur said.

Meanwhile, some companies have been reporting to the FDA that manufacturing costs have exceeded sales prices, forcing them out of certain markets, according to the oncology chief.

One potential solution would be a government contract with manufacturers to produce a “buffer stockpile” of essential oncology drugs, Pazdur said.

There are currently shortages of 17 cancer drugs, and the FDA is working with industry players to address them. For example, one of the three approved manufacturers of fludarabine injection was granted “regulatory discretion” to use unapproved, but FDA-evaluated, raw materials.

Ultimately, the FDA can’t solve this problem on its own, Pazdur told The Cancer Letter. A shortage is “the end result of a failure in the market,” Pazdur emphasized.

It’s an issue that the agency has been pressed on before. In March, the FDA’s actions in preventing and responding to the shortages were probed in Congress as the House Committee on Energy and Commerce launched an investigation to uncover if the agency is “effectively using its existing authorities.”

https://www.fiercepharma.com/manufacturing/failure-market-results-persisting-shortages-fda-oncology-director-says-report