DCAA Announces Reorganization Plans
Client Alert | 1 min read | 04.09.25
On April 7, 2025, the Defense Contract Audit Agency (DCAA) announced agency reorganization plans aimed at reducing the number of field offices and centralizing audit operations. DCAA plans to close 40 smaller audit suboffices around the country, many staffed with fewer than 10 personnel, to reduce the costs of associated leases. The agency will also consolidate the existing Region Audit Directorates for the Eastern, Central and Western Regions and four Corporate Audit Directorates (CADs), located proximate to large contractors, into three new Directorates—Land, Sea, and Air. The audit offices of the CADs will be merged into the new Directorate that most closely aligns with a contractor’s product. DCAA’s announcement states that the organizational restructuring will be completed by September 30, 2025. The full text of the announcement is available here.
It remains to be seen how the agency will apply its new Directorate structure to contractors spread across the country and how the reorganization will impact the agency’s ability to perform audit work on site at contractor facilities.
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Client Alert | 4 min read | 04.10.25
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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GAO Finds Authority to Use Noncompetitive Procedures Is Not Carte Blanche