Heparin Resource Center

Heparin Resource Center

Lessons from Heparin
The story of how contaminated heparin found its way into the global drug supply dominated pharmaceutical industry news in 2008. The following articles and links document the crisis and interpret its significance and meaning.

Interviews and Related Articles

• The Sleuthing Behind Heparin
  Finding the contamination source was no small feat.
• Evaluating the Prospects of Synthetic Heparin
  Dr. Jian Liu has recognized the vulnerability in the heparin supply for many years, and sees synthetic heparin as a solution.
• A Skeptic Remains
  Loyola University’s Dr. Jawed Fareed believes further heparin studies need to be done lest the past repeat itself.
• Moheb Nasr on Heparin’s Lessons
  The FDA’s lead scientist on the heparin case recounts the challenges and learnings from a very eventful year.
• USP Tests to be Updated
  Emil Ciurczak talks with Bill Cook, Chief Metrology Officer, and Darrell Abernethy, Chief Science Officer, USP.
• Contaminated Heparin Associated with Adverse Clinical Events
  A key article from the New England Journal of Medicine.
• FDA Landing Page on Heparin
• Countries Where Contaminated API Was Distributed
• Congressional Testimony by FDA CBER's Janet Woodcock
• Weak Links
  A recent survey suggests that manufacturers don’t have as much control over supply chain security as they think they do.
• NIR and Raman in the Detection of Biopharmaceuticals
  This presentation from AAPS 2008 touches on the role that NIR and Raman can play in detecting contaminants in heparin.

Opinion: Interpreting the Crisis

• From the Editor: Curing Pharma’s China Syndrome
  Accountability - on the part of finished drug manufacturers as well as their API suppliers - will prevent future quality and P.R. disasters.
• Cracks in the Armor: Securing the Global Supply Chain
  Processes and systems must be well understood before technologies can be implemented.
• Heparin Drama Underscores Need for More FDA Funding and Supplier Oversight
  April brought painful reminders of the human cost of pharmaceutical quality control problems, the need for more FDA resources and better supplier risk management.
• Outsourcing: Look at the Long Term Risks vs. Benefits
  The Heparin case provides an excellent opportunity to use risk analysis, as defined in ICH Q9,to look at the costs of outsourcing manufacturing to China.
• Are You Crisis-Proof?
  Tunnell’s Jaime Velez offers advice for manufacturers wary of where their raw materials are coming from and what preventive measures they can put in place to avoid their own crisis.
• Views from the Trenches
  Peers offer their opinions on standards for heparin.
• The Global Supply-Chain: Or, Which Shell is the Pea Under?
  There are solutions to making raw materials safer, but they involve coordinated technology and efforts.
• Will the High Costs of Analytics Permit Future Cases of Heparin Contamination?
  Any crime covered by the press inspires a wave of copycats. So, it seems, the global heparin supply chain will have to be closely monitored for some time.

How the Story Broke: Key News Chronicling the Crisis

• Problems in Blood Drug Lead to Halt by Factory
• Contaminant Found in Heparin
• FDA's Import Alert: Misbranded API's
• FDA's 483 Letter Issued to SPL's Chinese Affiliate
• Twists in Chain of Supplies for Blood Drug
• FDA Pinpoints Contaminant in Baxter's Heparin
• Chinese Authorities To Become More Rigorous On Heparin Production
• U.S. Pharmacopeia Announces Revised Heparin Monographs and Reference Standards
• More Seizures of Contaminated Heparin from Ohio Manufacturer