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On February 10, 2020, the U.S. Court of Appeals for the Federal Circuit issued its long-awaited decision in Acetris Health LLC v. United States, No. 2018-2399 (Feb. 10, 2020).
Continue Reading What Does it Mean to Manufacture? Federal Circuit’s Acetris Decision Fundamentally Alters Trade Agreements Act Compliance

Selling drugs to the Government just got a lot simpler.  In Acetris Health LLC v. United States, No. 2018-2399 (Feb. 10, 2020), the Federal Circuit opened the Government door…
Continue Reading Federal Circuit Changes the Game for Selling Single-API Drugs to the Government

This month, and with great fanfare, the U.S. Department of Justice (DOJ) announced its creation of a Procurement Collusion Strike Force.  We know what you’re thinking, and no – this…
Continue Reading A Few Thoughts on DOJ’s Procurement Collusion Strike Force

Trade Agreements Act compliance changed fundamentally three years ago. Or, so we thought on December 7, 2016, when the U.S. Court of International Trade (“CIT”), the appellate body for country…
Continue Reading The Evolution of TAA Compliance Post-Energizer – “Substantially Transformed” Has Substantially Changed

On October 9, 2019, the President issued two executive orders that require agencies to formally provide official guidance before enforcing any new jurisdiction or legal standards. In other words, agencies…
Continue Reading New Executive Orders Aim to Eliminate Unfair Surprise in Civil Enforcement Actions by Formalizing Guidance Documents

First things first, I’m sorry about the title; I couldn’t resist. The longer, alternate title would have been “Rest In Peace – the Past Performance Information Retrieval System Sleeps with the Fishes.” But that doesn’t have the same kind of obscure, punchy, epitaph-type quality that I’m aiming for. So instead, I give you get a garbled mess of an acronym to remind us that the Past Performance Information Retrieval System (“PPIRS”) – the system once used by the U.S. Government to house the final performance assessments for government contractors – is no more. As far as epitaphs go, I think that most of us would agree that “R.I.P.” is just about what an acronym deserves.
Continue Reading R.I.P. PPIRS

Earlier this month, the U.S. Department of Justice (“DOJ”) and the U.S. Department of the Treasury’s Office of Foreign Asset Controls (“OFAC”) both issued guidance regarding their expectations for corporate compliance programs. Both documents are geared towards establishing more rigid frameworks for assessing compliance programs. A common theme among both pieces of guidance appears to be the identification and allocation of responsibility to individuals, especially management. Additionally, the fact that the agencies released their guidance within days of each other could be read as a clear signal from federal authorities that they are serious about increasing their focus on individual accountability for corporate wrongdoing.
Continue Reading Feds Focus on Individuals in Evaluating Corporate Compliance Programs

In 2012, the Penn State Lions went 8-4 on the field, passing 3,283 yards, rushing 740 yards, and scoring 349 points. This credible performance earned it a respectable 38th ranking out of the 124 schools in the NCAA’s Division I Football Bowl Subdivision. But few will remember Penn State’s athletic performance in 2012. What people will remember instead is that 2012 was the year the University’s Special Investigative Counsel issued its report into the actions of Penn State Coach Gerald Sandusky.
Continue Reading From the Big Easy to the Big Ten, And Beyond: What the Process of Reforming the New Orleans Police Department Can Teach Colleges and Universities

On January 25, 2018, Associate Attorney General Rachel Brand issued a memorandum (the “Brand Memo”) limiting the use of agency guidance documents in affirmative civil enforcement cases. The memorandum builds on Attorney General Jeff Sessions’ November 16, 2017 memorandum prohibiting DOJ from promulgating guidance documents that create rights or obligations that are binding on regulated parties. When DOJ issues a guidance document with voluntary standards, it must also contain a statement that noncompliance is not subject to future DOJ enforcement actions. The Brand Memo makes clear that this principle also applies to other agencies’ guidance documents. In other words, agency guidance, in and of itself, cannot create new binding legal requirements.
Continue Reading “Brand Memo” Prohibits US DOJ From Converting Agency Guidance Into Binding Legal Obligations In Civil Enforcement Actions