What Have We Learned Ten Years After the Heparin Crisis?
Ten years ago, contaminated heparin sourced from China entered the U.S. market, leading
to 81 deaths (1). Naturally, this spurred considerable attention to the pharmaceutical
supply chain, particularly as the products were supposed to pass through several screenings
before entering the market (1).
The pharmaceutical supply chain has become increasingly complex due to its global nature.
While the heparin incident highlights the dangers inherent to a global supply chain,
there are still several benefits, most notably greater access to critical medicines for patients
worldwide. With that in mind, this means protecting drug product is more critical than
ever. As we have seen even within the past year, a natural disaster in one region can result
in shortages of critical drugs in another. And do not forget there are bad actors out there,
too. I have seen the 60 Minutes segment about the Eli Lilly warehouse theft in 2010
multiple times and the brazenness of that theft never ceases to amaze me. While writing
this, I even received a news alert from the U.S. FDA regarding a theft of 16,000 packages
of injectable fertility drug products in Italy (2).
In light of the anniversary of the heparin contamination incident, this year’s PDA/FDA
Joint Regulatory Conference will focus on supply chain-related issues. Various sessions will
cover a range of supply chain topics, including supplier quality audits, disaster recovery,
the Food and Drug Administration Safety and Innovation Act (FDASIA), distribution
challenges for cell and gene therapy products, raw material oversight and more.
I look forward to attending these sessions and learning how industry and global regulators
are responding to the challenges of the growing supply chain. There will certainly be
extensive Q&A and panel discussions featuring FDA representatives. It all sounds exciting
and I hope you can come to D.C. this September to participate.
You may also see me and my team about, possibly carrying equipment to film another
“On the Issue” video. On that note, we have been expanding our library of “On the
Issue” videos, including one conducted entirely in Japanese featuring PDA board
member Masahiro Akimoto and Japan PMDA representative Issei Takayama. Do
not worry! We worked with both of them to subtitle the video in English. It can be
found on the PDA Letter videos page and on the PDA YouTube channel.
- Greenemeier, L. “Heparin Scare: Deaths from Tainted Blood-Thinner Spur Race for Safe Replacement.” Scientific American (Nov. 4, 2008)
- “More Than 16000 Packages of Fertility Drugs Stolen in Italy.” Maas & Peither Publishing (June 18, 2018)