Tainted Heparin Will Mean More Scrutiny of Drug Manufacturers

Implications: Regardless of the reason (greed, carelessness, incompetence, etc.) that Chinese heparin became tainted, the end result will be increased scrutiny on imported raw materials and other ingredients, not only from China, but from all 3rd World suppliers. How the FDA and other regulatory agencies actually intend to step up the scrutiny is still open to debate, but the ultimate responsibility lies with the license holder.

Analysis: The US FDA is now saying that it believes that heparin sourced from China and distributed in the US by Baxter was intentionally contaminated. The motive purported by the FDA was economic benefit - substituting or dilution with a cheaper ingredient. This theory has precedence in China - in recent history ethylene glycol (the main ingredient in automotive antifreeze) has been used in place of glycerin, with catastrophic results.

No matter what the root cause of the tainted heparin, the FDA (and other world drug regulatory agencies) must take steps to prevent a repeat from occurring. The current financial environment is extremely tight for the FDA, so the possibility of stepping up on-site inspections in international locations isn't there. Besides, the biannual inspection program undertaken by the agency is not likely to stop situations like the current one from occurring. Rather, pharmaceutical and biotech companies will have to increase their scrutiny of overseas suppliers. This is not a new requirement - the FDA has always expected that sponsors (i.e., those holding the drug approvals) are taking appropriate steps to ensure the quality of raw materials and processing steps produced/undertaken in their own factories and by contractors. It's very likely that the FDA and international counterparts will turn to requiring increased scrutiny by sponsors. The big question is how will this be achieved.

If you're interested in my thoughts on the next steps, please contact me via GLG.