At Fisher Clinical Services we receive thousands of requests per year to procure Rescue-Medication, Standard of Care or Comparator Medication for clinical trials across the globe. Many of these requests are for simple trials like investigator initiated trials at one site in one country or for trials only taking place within the EU or the US.
However, I am often approached by colleagues who say “We want to use comparator drugs that we have sourced in Europe for a US trial, is that okay?” This leads me to ask the following questions:
• Do you know if this product is also marketed in the US?
• If so, is the Marketing Authorization Holder the same as in Europe? You need to take care not to violate regulations on the originator’s territory rights
• Have you considered what might happen if the comparator drug is delayed at customs clearance?
• Do you have a Transmissible Spongiform Encephalopathy(TSE) / Bovine Spongiform Encephalopathy(BSE) free statement?
• Is the medication Child Proof according to US regulations?
• Have you requested an Investigational New Drug (IND) number?
And so the list of questions goes on. Especially the query about TSE / BSE , when tablets or capsules contain animal origin such as lactose. You need to have the full traceability back to the original source of the corresponding animal – the cow - including its pedigree. Yes, the pedigree of the cow itself!
And why are we generally asked to source EU medication for the US market? In most cases it is to benefit from price advantages in Europe compared to the US. But do you really want to add additional risks in terms of logistics, considering 2-8°C medication, additional timelines for processing the USDA (United States Department of Agriculture) and other required documentation? What do you do when you have a temperature excursion at the site or a stock out situation and you need urgent replacement shipments from EU to the US site? Surely all of these potential pitfalls would encourage you to source comparator drug locally?
In essence, it is feasible to import comparator drugs from the EU to the USA. However, it has to be evaluated on a case-by-case basis – do the benefits of cost saving outweigh the longer clinical trial supply chain and the additional risks? My advice is to consult with the Fisher Clinical Services Centre of Excellence for Comparator Sourcing from the very beginning while drafting the protocol. That way we can give you our recommendations based on our 27+ years of experience in the clinical trial supply world. Contact us today.