DCMA Revises Cyber Supply Chain Review: Updated Guidebook Modifies Audit Standards
Client Alert | 1 min read | 07.16.19
As anticipated, the Defense Contract Management Agency (DCMA) revised its Contractor Purchasing System Review (CPSR) Guidebook as of June 14, 2019, with the most significant updates to Appendix 24, Supply Chain Management Process, to further address supply chain compliance with DFARS 252.204-7012. As we previously noted, the CPSR Guidebook was revised earlier this year to address DoD guidance related to management and oversight of the supply chain in connection with DFARS 252.204-7012.
While much of the CPSR review criteria remain the same, noteworthy revisions include:
- Asking contractors to “show how they have determined” that their subcontractors have an adequate information system that can handle Covered Defense Information, versus the prior guidance to ask contractors to “validate” the adequacy of subcontractor systems.
- Broadening supply chain requirements by applying the Guidebook’s language to “subcontractors,” rather than just “first tier suppliers” as in the prior version.
- Clarifying that the CPSR review is focused only on the protection of “Covered Defense Information” and not “Controlled Unclassified Information” more broadly.
Insights
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Hikma and Amici Curiae Ask Supreme Court to Revisit Induced Infringement by Generic “Skinny Labels”
In Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., C.A. No. 20-1630 (D. Del.), brand manufacturer Amarin brought an induced infringement claim against Hikma’s generic icosapent ethyl product, which lists Amarin’s Vascepa® as the reference listed drug. Vascepa was originally approved by the U.S. Food and Drug Administration (“FDA”) to treat severe hypertriglyceridemia, and later, Amarin obtained patents and approval for Vascepa as a treatment to reduce cardiovascular risk in certain patient populations. Hikma’s Abbreviated New Drug Application (“ANDA”) for generic icosapent ethyl included a Section viii statement that Hikma was not seeking approval for the patented cardiovascular indication along with a “skinny label” that included only the indication for severe hypertriglyceridemia.
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