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

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

By David Gallacher and Curt Dombek

Last year in January 2011, the President signed the 2011 National Defense Authorization Act (Pub. L. No. 111-383, Section 846), which included a “Buy American” requirement for photovoltaic devices being purchased by the U.S. Department of Defense (“DoD”). We previously discussed this new requirement in our blog. Twelve months later, the DoD has issued an interim rule to implement this new requirement. See 76 Fed. Reg. 18858 (Dec. 20, 2011). The interim rule appears to be straightforward, implementing exceptions and manufacturing requirements with which most companies are already familiar under the Buy American Act or the Trade Agreements Act, but there is some fine print of which all companies selling photovoltaic devices to the DoD should be aware.


Continue Reading “Buy American” and Photovoltaic Devices – Interim Rule Issued by DoD

By David Gallacher

2012 will see changes regarding U.S. free trade agreements relating to, first, the dollar thresholds at which the various agreements apply to federal purchases and, second, the likely expansion of the scope of the World Trade Organization Government Procurement Agreement ("WTO GPA"). The updated dollar thresholds are important for government contractors because the thresholds determine when a contract is subject to the Buy American Act ("BAA") or the Trade Agreements Act ("TAA"). As to the WTO GPA, its expansion should provide significant increased access to the U.S and many of its trading partners in international procurements, although the hoped for accession of China to the WTO GPA remains stalled


Continue Reading New 2012 Updates to U.S. Free Trade Agreements Expected; No Progress With China