DSCSA Deadline: Coming Soon As highlighted numerous times since its announcement, the FDA has provided an exemption for certain eligible trading partners from Enhanced Drug Distribution Security (EDDS) Requirements of the Drug Supply Chain Security Act (DSCSA). These exemptions vary in length depending on the trade partner; for manufacturers and repackagers, the deadline for compliance […]

Gary Lerner, Founder and President of Gateway Checker, was recently a guest on the Next Level Supply Chain Podcast by GS1 US. Speaking with VP of Innovation and Partnerships at GS1 US, Reid Jackson, their discussion highlighted the importance of a secure supply chain in keeping healthcare patients safe. Their conversation covers the Drug Supply […]

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 […]