Up Next in 340B

Several clients have received a letter from Ferring that seems off for several reasons. For starters, Ferring is requesting “detail” of all 340B utilization but no specific data points are provided. For one client, they do not have any purchases of their product. For another, the letter was addressed to a contract pharmacy and the 18-month timeframe they are requesting data for only has 3 purchases of one of the 3 NDCs listed in the first year but none in the next 6 months. Why these are flagged as “unusual” is a mystery to me, but based on a client’s email back to Ferring, it seems they are looking for clarity on duplicate discounts despite the letter being a catchall. 

• If you receive this notice, please investigate, but if this is baseless, consider sending it to HRSA to report as an example of what entities receive. Inquiries that are vague and not addressed to the AO or the PC are very challenging to respond to and can be a misuse of an entity’s time. 

Genentech also sent out a “reminder” email on 9/22 referring to a letter that was sent on 5/19/25…that I have to say we at Rx|X never saw and neither did four attorneys that we asked. I am guessing this is everyone else’s experience because the email starts with, “in case you didn’t see the policy update letter sent to 340B covered entities in May 2025.”

The letter and email are focused on one thing: ADM. Genentech says, “We ask you to discontinue any non-transparent product movement or distribution arrangements. These non-transparent arrangements include: practices such as alternative distribution models, “banking” orders outside of a reasonable window, virtual returns, consolidated replenishment, central fill, or virtual credit.”  This is a broad list of things not to do, but it is also policy versus policy and I am uncertain on how HRSA can be involved. Please work with attorneys and wholesalers to see where things stand in your organization.