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Regulatory News | 05 May 2017 | By Michael Mezher
Drugmakers should be mindful of the risks involved with relying on foreign manufacturers as part of their supply chain, said Thomas Cosgrove, director of the US Food and Drug Administration's (FDA) Office of Manufacturing Quality within the Center for Drug Evaluation and Research.
Speaking at the Food and Drug Law Institute's annual conference on Friday, Cosgrove detailed some of the biggest challenges drugmakers face when contracting with foreign manufacturers, which firms increasingly contract with to produce everything from excipients and active pharmaceutical ingredients to finished drugs.
According to Cosgrove, it's important for companies to understand the risks involved in relying on foreign manufacturers and take appropriate steps to mitigate those risks.
"If any firm in the supply chain falls down, the supply chain itself can fall down. This is a very real risk," Cosgrove said, noting that the agency can reject applications for drugs over good manufacturing practice (GMP) issues.
"You're pretty confident that those European companies you're dealing with have a strong culture of quality and can perform pretty consistently," Cosgrove said.
But, in other parts of the world, Cosgrove said that companies might not "have a deep experience with how the US regulations work or even how to deal with the FDA," and may not have been inspected by the agency before.
While FDA has stepped up its inspections of foreign drug manufacturers in recent years, there are more than 1,000 foreign drug facilities the agency has never inspected.
Since the passage of the Food and Drug Administration Safety and Innovation Act in 2012, Cosgrove said the agency has "reached parity" between inspections of foreign and domestic drug firms.
As a result, Cosgrove said that FDA is getting better acquainted with the risks involved with international manufacturing, in some cases more so than US drugmakers themselves.
"FDA investigators are finding out quality and compliance problems and violations that sponsors here in the US, Europe and elsewhere had no idea existed, and this is wreaking havoc on those supply chains," he said.
Some of these problems include failing to investigate quality issues, not responding to customer complaints, refusing to cooperate with FDA inspectors and data integrity issues.
"I thought several years ago that [data integrity] would maybe be a flash in the pan and we would not be talking about it now, but if you look at the working letters, you see about 60% of the GMP warning letters coming out of FDA cite data integrity issues," Cosgrove said.
However, Cosgrove said that drugmakers can limit these risks by knowing the issues foreign firms might struggle with, and by implementing a "robust and thorough auditing approach before [deciding] to do business with a manufacturer."
Tags: Office of Manufacturing Quality, Foreign Inspections, Supply Chain