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David Gallacher is a partner in the Government Contracts, Investigations and International Trade Practice Group in the firm's Washington, D.C. office.

The U.S. Department of Veterans Affairs (“VA”) Medical Surgical Prime Vendor (“MSPV”) 2.0 Program (discussed previously here and here) has yet to make it off the ground, but in March 2021 the VA announced plans to eliminate the program by September 2023 and instead purchase from the Defense Logistics Agency’s (“DLA”) separate MSPV catalog. The VA and DLA MSPV programs are how the VA and DLA (separately) purchase most of their medical, surgical, and laboratory equipment for care centers across the country (and abroad, in the case of DLA). The VA and DLA have been exploring the possibility of consolidation since at least January 2019, but many vendors relied on the VA’s representations that it would not make any decisions on potential consolidation until at least 2025. So when the VA informed stakeholders of its new September 2023 target, Medline Industries, Inc. (“Medline”), one of the prime vendor awardees under the VA’s MSPV 2.0 Program, responded by filing a bid protest at the U.S. Court of Federal Claims. On May 28, 2021, the VA and DLA decided to take corrective action, asking the Court for six months to re-evaluate the issues raised by the protest. It seems that the government did not have all of its ducks in a row prior to announcing the targeted transition.
Continue Reading Ducks (Not) in a Row – VA Agrees to Take Corrective Action in Transitioning MSPV 2.0 Requirements to DLA

The Biden Administration has taken (at least temporarily) the teeth out of a Trump-era Executive Order that directed the government to “Buy American” for essential drugs and medical devices. President
Continue Reading “Buy American” Update: Essential Medicines May Continue to Come From Abroad (For Now)

On February 24, 2021, President Biden signed Executive Order 14017, “Executive Order on America’s Supply Chains,” requiring a review of global supply chains that support key U.S. industries in an attempt to improve supply chain security for the U.S. government and U.S. companies. The new Executive Order appears to be an initial step focused on information gathering. Comprehensive reforms and supply chain strategies are likely to follow once the White House has collected key information.
Continue Reading Finding the Weak Links – President Biden Executive Order Demands Review of Critical U.S. Supply Chains

On January 25, 2021, President Joe Biden signed an Executive Order on “Ensuring the Future is Made in All of America by All of America’s Workers,” laying his administration’s foundation for further strengthening Buy American laws and encouraging domestic procurement. Using the broad phrase “Made in America Laws,” the EO aims to strengthen “all statutes, regulations, rules, and Executive Orders relating to Federal financial assistance awards or Federal procurement, including those that refer to ‘Buy America’ or ‘Buy American.’” This comes just days after the FAR Council’s implementation of President Trump’s Executive Order 13881, which required significant changes to the regulations implementing the Buy American Act, 41 U.S.C. §§ 8301-8305 (“BAA”), as discussed in our prior blog article. While only time will tell if the FAR Council will revisit the newly released regulations – they probably will, but not until later this year – we have provided below several key points from the EO so companies can start planning now for future developments.
Continue Reading Made in America – President Biden’s Executive Order on Buying (Even More?) American

On January 19, 2021, the Federal Acquisition Regulatory Council published the final rule amending the Federal Acquisition Regulation (“FAR”) in accordance with President Trump’s Executive Order 13881, “Maximizing Use of American-Made Goods, Products, and Materials.” As we discussed in our prior blog articles here (discussing the September 2020 proposed rule) and here (discussing the July 15, 2019 order), the Executive Order required significant changes to the regulations implementing the Buy American Act, 41 U.S.C. §§ 8301-8305 (“BAA”). The final rule varies very little from the September 14, 2020 proposed rule (discussed in greater detail here). Accordingly, the final rule amends applicable FAR clauses with three key impacts:
Continue Reading “Buy (More) American” – Final Rule Implements Changes to the Buy American Act Regulations

On October 30, 2020 the FDA published a list of essential medicines, medical countermeasures, and critical inputs as required by President Trump’s August 2020 Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (Executive Order 13944), which required the U.S. government to purchase “essential” medicines and medical supplies produced domestically, rather than abroad. We previously wrote about this Executive Order in August (available here), expecting that once the list was issued, government agencies would begin implementing the “Buy American” priorities for these products and materials. The FDA has identified around 227 drugs and 96 devices, along with their respective critical inputs or active ingredients, that the FDA believes “are medically necessary to have available at all times” for the public health. Agencies across the federal government should now begin making non-competitive awards “to the maximum extent permitted by law,” for drugs and medical supplies on this list that are produced in the United States. We have yet to see how agencies will implement these requirements in regulations or class deviations, but publication of this list is an important first step in implementing the rest of the “Buy American” priorities in the Executive Order.
Continue Reading “Buy American” Update: FDA Issues List Of Essential Medicines Required By Executive Order

On September 14, 2020, the Federal Acquisition Regulatory Council published the long anticipated proposed rule amending the Federal Acquisition Regulation (“FAR”) in accordance with President Trump’s Executive Order 13881, “Maximizing Use of American-Made Goods, Products, and Materials.” As previously discussed here, the Executive Order, signed on July 15, 2019, required significant changes to the implementing regulations of the Buy American Act, 41 U.S.C. §§ 8301-8305, changing policies dating back nearly 70 years. Accordingly, the proposed rule seeks to increase both the domestic content requirements and the evaluation preferences provided by the FAR for domestically manufactured goods, particularly with regard to domestic content requirements for steel or iron end products and products made predominantly from iron or steel. Most significantly, however, the proposed rule will revive heightened restrictions for commercially available-off-the-shelf (“COTS”) products that are made predominantly of iron or steel, requiring both the end product and 95 percent of the component parts be domestically sourced in order to qualify under the rule. The COTS exception remains available for other end products (that are not made predominantly of iron or steel), but the proposed rule still will impose heightened obligations and vendors now need to scrutinize their supply chains even more closely, even for COTS items. The FAR Council is accepting comments through November 13, 2020. A final rule is likely by early-2021.
Continue Reading Proposed Changes to the Buy American Act Regulations Implementing Trump Executive Orders

Beginning October 15, 2020, the U.S. Small Business Administration (“SBA”), implementing the 2015 National Defense Authorization Act (“NDAA”), will begin requiring women-owned small businesses (“WOSBs”) and economically disadvantaged WOSBs (“EDWOSBs”) to undergo a formal certification process to be eligible under the Procurement Program for Women-Owned Small Business Concerns (the “Program”). Thus, WOSBs and EDWOSBs no longer will be allowed to self-certify that they meet the Program requirements to compete for set-aside or sole source contracts, as has been the case for the last few decades. Instead, WOSBs and EDWOSBs now must apply for a formal government-issued certification at https://beta.certify.sba.gov/, which includes creating an account and uploading the necessary paperwork to establish eligibility. 13 C.F.R. Subpart C (§§ 127.300 – 127.356).
Continue Reading Women-Owned Small Business Self-Certification Ends October 15, 2020 When SBA Begins Requiring Formal Government-Issued Or Third-Party Certifications for Awards

The U.S. Small Business Administration (“SBA”) recently announced that the federal government exceeded its small business contracting goal by awarding $132.9 billion dollars in federal contracts – 26.5% of the government’s total procurement spending – to small businesses last fiscal year, with at least an additional $90.7 billion in subcontracts.  The SBA recently released statistics in its FY 2019 Small Business Procurement Scorecard, available here and here.  Also notable in these reports: (a) for only the second time ever the government met the 5% woman-owned small business goal; (b) the government met the service-disabled veteran-owned small business goal (3%, awarded 4.39%); and (c) the government also met the small disadvantaged business goal (5%, awarded 10.2%).  The government did not, however, meet the 3% HUBZone goal, coming in at 2.28%.  That said, small business contracting was up across all categories.  Here we provide a summary of the SBA’s findings, noting some of the potential opportunities available for small business contractors, while also highlighting some of the risks inherent in doing business with the U.S. government.
Continue Reading Government Small Business Contracting Continues to Increase: Creating Opportunities and Potential Pitfalls

On August 6, 2020, President Trump signed the “Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States,” requiring, among other things, the U.S. government to purchase “essential” medicines and medical supplies produced domestically, rather than abroad. Citing a need to reduce U.S. dependence on foreign suppliers, the Order sets forth several new requirements aimed at establishing reliable, long-term domestic production of essential drugs and devices, including their component parts. To be clear, this is a tall order: the Food and Drug Administration (FDA) will need to assemble a list of critical supplies and medicines; agencies will need to assess ways to secure the supply chain for both equipment and medicines; the Environmental Protection Agency (EPA) will need to consider how it can accelerate domestic manufacturing requests; the U.S. Trade Representative (USTR) and the Department of Defense (DOD) will need to re-negotiate the terms of international agreements; the Department of Veterans Affairs (VA) may (or may not) be exempted; and – lest it go without saying – everyone will have to update their regulations. While this “Buy American” requirement seems to take effect as soon as the FDA issues its list of critical materials, the Order may leave intact (at least temporarily) some exceptions, which may allow companies time to examine and adjust their supply chains. Over the longer term, most required agency actions are ordered to be realized within 90-180 days, but the inevitable regulatory updates will lag (far?) behind. For now, we find ourselves in a bit of a Twilight Zone – “the middle ground between light and shadow, between science and superstition, and … between the pit of man’s fears and the summit of his knowledge” – forced to guess which parts of this new Order are real and immediate, and which will leave us stuck in a “darker dimension.”
Continue Reading “Buy American” in the Twilight Zone: Executive Order Strengthening the U.S. Public Health Industrial Base

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