December 19, 2024
Pharmacy Benefit Manager Legislation and the Impact on the Pharma Supply Chain
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 […]
December 11, 2024
Trump’s Tariffs and Drug Prices
Following his election victory, president-elect Donald Trump announced intentions of implementing tariffs on Canada, Mexico, and China; these tariffs include 25% tax on imports from both Mexico and Canada, and an additional 10% increase on the tariffs already in place on Chinese exports to the United States. The goals of these imports, according to the […]
November 27, 2024
What Isn’t Included in the Recent Exemption
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 […]
November 22, 2024
So, You Think You’re Exempt
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 […]
November 22, 2024
What Is Exempt, per recent DSCSA Update
According to the DSCSA Exemption Announcement from the FDA on October 9th, here are the specific components of the legislation that eligible trading partners are exempt from. Section 582(g)(1)(A-F) for Manufacturers and Repackagers, Wholesale distributors, and Dispensers ‘‘(A) The transaction information and the transaction statements as required under this section shall be exchanged in a […]
