Global Supply Chains Strain FDA's Traditional Model Says Agency Official

By Daniel R. Matlis

The Challenges associated with the globalization of manufacturing and supply chains in Life-Sciences were again brought to the forefront at last week’s FDA/Xavier Global Outsourcing Conference (GOC).

“Global Supply Chains Strain FDA’s Traditional Model” noted FDA’s Brian Hasselbalch during his Keynote during the GOC Conference. Mr. Hasselbalch works at the Division of Manufacturing and Product Quality, Office of Compliance at FDA’s CDER.

“The agency wants to hold sponsor companies more accountable for flaws in manufacturing processes of outside contractors both in the U.S. and abroad, and for certifying that contractors have followed FDA drug-making standards,” Marla Phillips, founder of Med-XU and the conference’s director told the Wall Street Journal.

According to Mr. Hasselbalch presentation slides, the Agency is working to address the strains associated with Medical Product Globalization Trends including:

  • More foreign facilities supplying the U.S.
    • Most drug manufacturing facilities are not located in the U.S.
    • The number of non US facilities is growing
  • Increasing volume of imported products
    • Over 80% Active Pharmaceutical Ingredients come from outside the U.S.
  • Greater complexity in manufacture and supply
  •  Shipments outside import system
    • Rogue wholesalers / brokers
  • Imports involving countries with less developed regulatory systems
    • Unregistered firms
    • “Shadow” firms

To identify key initiatives Life-Science companies are undertaking to address the issues raised by FDA; Axendia has launched a research study titled: “Global Supply Chain Visibility and Security; Business Necessity, Regulatory Imperative”.

To provide your input on this critical issue facing the industry, please complete a short survey (approximately 10 min.) by following this link:

All respondents will be eligible to receive a copy of the Axendia’s Research Report once it is completed.

We look forward to your contribution.

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