Last year, vials of the decades-old chemotherapy drug fludarabine could be purchased for a wholesale price of around $110. Not so much anymore.
This year, one company—Areva Pharmaceuticals—has jacked the figure up to $2,736, Stat News reports.
What’s going on with the aging chemotherapy used to prepare patients for cancer treatment?
It all comes down to supply chain problems triggering shortages that affect the only other two suppliers of the drug in the United States—Teva and Fresenius Kabi.
This and other well-documented shortages aren’t going away any time soon, according to Bindiya Vakil, CEO of Resilinc, a California-based firm that helps companies from a variety of industries mitigate supply chain problems.
While shortages of high-profile drugs such as Adderall and amoxicillin have garnered headlines recently, Vakil points to a recent FDA warning that has the potential for more far-reaching consequences.
The agency flagged shortages of more than a dozen drug ingredients, two of which are included in Adderall. Others include bacteriostatic saline, which is necessary for diluting drugs for IV injections, and compounds used in common drugs for anesthesia, water retention and calcium deficiencies.
“What we don’t appreciate as much is that our drug supply is highly vulnerable because a lot of the source materials that go into developing the active pharmaceutical ingredients come from China,” Vakil said in an interview. “India is a huge market for generic manufacturing that we rely on in the U.S. And India is heavily dependent on China for those source materials that they transform into the APIs. We don’t have independence in our drug supply at all.”
The raw material supply problems are so serious that Vakil expects the Adderall shortage, for example, to persist for up to another 52 weeks. There are no quick fixes in drug manufacturing and the FDA approval process to get a new site up and running is lengthy.
Compared to other business areas, biopharma has lagged in building supply chain resilience, the expert said. In this regard, Vakil said that the industry trails high-tech by some 10 years, citing companies with robust supply chain mapping and monitoring programs.
“The drug industry is not really taking a proactive approach to understanding their supply chain dependencies. And they continue to be surprised time and time again,” Vakil said. “It isn’t easy to build resiliency but the time to do it was yesterday. The problem is not going away. And here in the U.S., as the population ages, the demand for medications is only going to go up.”
And prices will too, if Areva’s experience with fludarabine is an accurate indicator.
In explaining its price, the company told Stat News that the API comes from China but from a supplier that is not approved by the FDA, requiring Areva to undergo thorough testing, reporting and quality control at its plant in Europe.