Vendors that contract with employers to source international drugs for employees

[MaryMB]

I'm hearing about more and more vendors that claim to be able to save self-funded employers on their rx spend by sourcing FDA-approved name-brand medications from countries such as Canada, the UK, Australia and New Zealand. The vendors contract with employers to offer this program to employees, then the vendor works directly with employees to obtain their prescriptions from pharmacies outside the US under FDA personal importation guidelines. These vendors tell employees they can get their drugs for a $0 copay and generally charge the employer a percentage of the savings when the drug is sourced. I'm wondering what the legality is for the both employers offering these programs and employees participating in these programs. What compliance issues should employers consider before implementing these programs?

Thanks for any insight!

[Chaz]

You would need to look at the FDA rules regarding prohibitions on importing drugs, among other things.  We looked at it and, despite the vendors' marketing efforts regarding its legality ("We have an opinion from a law firm!"), we were unable to recommend that our client proceed with this program.

[Chaz]

Here's a follow-up:

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/electrx-and-health-solutions-llc-614251-03022023

 

[MaryMB]

Thanks, Chaz!

[WaterSt]

HI Mary, 

I work with a company that does that for self-funded group plan, it has worked great for my groups. I added it to a group this year, they saved $30k first quarter. They had 3 very expensive scripts they are now getting through this vendor partner.   If you want to email me, if you want to discuss I can give you my information. Let me know. Thank you!

Lisa