Reform Will Have to Wait In dramatic fashion, previously anticipated reform centered around pharmacy benefit managers was not a part of Congress’s end-of-year spending bill. As mentioned in my last post, this PBM reform included a ban on spread pricing and de-linking PBM fees from the list price. Advocates for reform emphasize how these measures […]

The Cost of PBMs Last week, Senator Elizabeth Warren (D-Massachusetts) and Josh Hawley (R-Missouri) introduced a bill requiring healthcare companies that own health insurers or pharmacy benefit managers (PBMs) to sell pharmacy assets within three years. If this legislation were to pass, it would significantly impact the pharmaceutical supply chain and perhaps help to control […]

Who Does It Apply To? Recently, I shared that eligible trading partners were temporarily exempted from specific components of the Drug Supply Chain Security Act, “Latest DSCSA Exemption”. However, considering the stabilization period ends tomorrow, I thought I’d share some further insights on what isn’t part of the recent exemption. First, as noted in my […]

DSCSA Deadline: Just Days Away The deadline for DSCSA stabilization is just days away, mandating Enhanced Drug Distribution Security (EDDS) requirements for manufacturers, repackagers, wholesale distributors, and dispensers. While the FDA announced an extension from certain components of the FD&C in the form of a phased approach, this extension only applies to certain eligible trading […]