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

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

Every two years, the U.S. Trade Representative updates the dollar values at which certain international trade agreements apply to certain types of U.S. government contracts. This means that certain contracts over the dollar thresholds are subject to the trade agreements, in other words, foreign-made products are placed on equal footing with U.S.-made goods. On the other hand, contracts beneath the dollar thresholds remain subject to certain “Buy American” provisions, preferring U.S.-made goods over foreign-made alternatives. Because most of you reading this post probably sell the Government products and components sourced from the global marketplace (where “Made in China” and “Made in Taiwan” may seem much more common than “Made in America”), you might want to know where these thresholds will sit until 2018. And since the U.S. Trade Representative took the unusual step of reducing these thresholds for 2016, this may be one of those rare occasions where a change in the regulations actually works to your advantage.
Continue Reading Trade Agreements Act Updates for 2016 – New Year, Lower Thresholds

The U.S. Court of Appeals for the District of Columbia Circuit has issued a ruling bringing to an end the long-running False Claims Act (“FCA”) case filed by relator Brady Folliard and providing useful guidance to resellers servicing the Federal government through the GSA Multiple Award Schedule program.[1]  In affirming the district court’s decision to grant Govplace’s motion for summary judgment and dismiss the case, the Court of Appeals found that Govplace did not knowingly violate the FCA because it reasonably relied on Trade Agreements Act (“TAA”) certifications from its distributor.  The holding of the Court of Appeals that “a contractor like Govplace is ordinarily entitled to rely on a supplier’s certification that the product meets TAA requirements” has broader implications than just the claims asserted against Govplace: it ratifies the long-standing industry practice of small business resellers leveraging the resources of their suppliers to comply with the requirements of their GSA Schedule Contracts.
Continue Reading DC Circuit Ruling Confirms Reasonableness Of Resellers Relying On TAA Certifications From Suppliers

The US is generally pretty keen on international free trade agreements. And why shouldn’t it be? After all, free trade agreements have the ability to open up foreign markets to US goods and services, allowing new and expanding opportunities for US companies. But “free trade” does not always mean “free trade” – it usually means “free-er trade, subject to numerous exceptions,” with the exceptions proving a constant irritant to our free trade partners. Case in point: two recent events – one in the European Union and one in Canada – demonstrate that “free trade” (subject to numerous caveats) is still a bone of contention, even among long-established trading partners. While “free-est trade” may be too much to ask for, maybe “free-er trade” with fewer strings attached would at least be a step in the right direction.
Continue Reading Free(er?) Trade – US, EU and Canada Quibble Over Market Access and Domestic Preferences

By David Gallacher

Two months ago, we published a brief list of compliance tips to keep in mind when dealing with Buy American requirements. We got an awful lot of


Continue Reading Buy American Redux – 15 Tips for Navigating the Buy American Maze

By Christopher Loveland and Jonathan Aronie 

While multi-million dollar False Claims Act (FCA) settlements paid by Government contractors get the lion’s share of the press, those with an attentive eye will have noticed a recent steady stream of more “contractor friendly” FCA decisions flying just under the national press’s radar. These cases, all arising in the context of the GSA Multiple Award Schedule program, serve as timely reminders that the FCA is not a blank check for opportunistic relators (plaintiffs/whistleblowers), and that relators must be in possession of facts actually supporting their allegations before walking into court. [1]


Continue Reading Common Sense Prevails Once Again: District Court FCA Ruling Serves As Reminder That Whistleblowers Need to Prove Recklessness Too

By David Gallacher

1. There is no single “Buy American” requirement – there are numerous statutes with differing requirements. Make sure you know which one applies.

2. Whether you are a prime or a subcontractor, certify only to the specific “Buy American” requirements in the RFP; do not make a broader certification than is required.


Continue Reading “Buy American” Compliance Tips

By David Gallacher

2012 saw several updates with regard to free trade agreements (“FTAs”) between the U.S. and its international trading allies. The most notable of these was the U.S.-Korea FTA (“KORUS”), but several other changes were made to the U.S. procurement regulations implementing other free trade agreements. Regrettably, negotiations with China remain stalled with no firm promises on the horizon. Following is a summary of some of the key changes over the last year.


Continue Reading Free Trade Agreement Updates for 2012

By David Gallacher

In December 2011 the World Trade Organization reached an agreement in principle to implement “historic revisions” to the World Trade Organization Government Procurement Agreement (WTO GPA), a trade agreement covering the public procurement markets in more than 40 WTO member states (including the United States). On March 30, 2012, the WTO GPA formally adopted these revisions. While the updates have been formally agreed upon, it may take months until two-thirds of the signatory countries ratify the agreement and make the changes official. Nevertheless, the international community appears to be moving forward with plans to implement, pending ratification.


Continue Reading Free Trade Agreement Updates – Changes to the WTO GPA and KORUS FTA