US FDA Commissioner Califf calls on industry to tackle supply chain quality issues

At a packed fireside chat at BIO this week, US Food and Drug Administration (FDA) Commissioner Robert Califf was reminded of the heparin scandal in 2008 where adulterated API imported from China was linked to 81 deaths in the US.

While this has led to greater FDA scrutiny​ across the pharma supply chain, including increased funding​ for overseas inspection units, Califf was challenged as to how the Agency will continue to try to ensure the safety of foreign-made APIs.

“We are revamping the inspections system, there will be many more inspections in India and China,” ​he told the San Franciscan crowd, adding the Agency is using a “risk algorithm”​ technology to help the inspectorate team in its approach to visiting facilities.

“We’re getting more and more data into the system​,” he said, but did not elaborate further. “You’ll hear a lot more about that over the next six months as that comes into place.”​

But he acknowledged that quality issues are not restricted to Chinese and Indian API and drugmakers.

“There are problems all over the world not just in those countries so we have to be cognisant of general risk which is the way we have to decide where to inspect,”​ he continued.

“We’re also working on mutual agreements with Europe so that we spend less inspection time in Europe.”​

Califf also called on industry itself to take responsibility for the quality of its supply chains.

“These firms that are making APIs are part of a supply chain which is essentially owned by the companies that eventually sell and distribute the drugs, so there’s a lot to be done by the companies themselves to make sure their suppliers are up to standard.​

“We need to develop a better ecosystem of quality to deal with these issues.”​