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.”
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Not So Fast – FDA Retracts Authorization for Some Respirators Made in China
Immunity under the Public Readiness and Emergency Preparedness (“PREP”) Act is a moving target for government contractors and other companies manufacturing or distributing personal protective equipment (PPE) in the COVID-19 public health response. We wrote previously about new liability protections afforded to manufacturers and distributors of certain face masks approved by National Institute for Occupational Safety and Health (“NIOSH”) through the Families First Coronavirus Response Act, and the later expanded scope of that protection provided by the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act and amended PREP Act declaration by Department of Health and Human Services. Until recently, the list of devices eligible for liability immunity seemed to be continuously growing as the COVID-19 public health response required more and more PPE. But last week, the Food and Drug Administration (“FDA”) took a significant step back, retracting its Emergency Use Authorization (“EUA”) for respirators from 75 manufacturers in China, which previously had been approved for use in the response to COVID-19. This retraction has the additional effect of disqualifying government contractors, and other companies that distribute newly unauthorized respirators, from PREP Act immunity in connection with these devices.
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PREP Act Update: All NIOSH-Approved Respirators Now Are Covered Countermeasures Eligible for Immunity
All respirators approved by the National Institute of Occupational Safety and Health (“NIOSH”) now are “covered countermeasures” under the Public Readiness and Emergency Preparedness (“PREP”) Act provisions of the Public Health Service Act, and their manufacturers and distributors are eligible for immunity from suits for injury and death resulting from use of the masks in the public health response to COVID-19. The Secretary for the Department of Health and Human Services (“HHS”) issued an updated PREP Act declaration implementing this addition to the covered countermeasures eligible for PREP Act immunity, with retroactive effect to March 27, 2020.
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COVID-19 Changes Contracting at the VA
The novel coronavirus (“COVID-19”) pandemic has given Department of Veterans Affairs (“VA”) contractors several powerful new tools in their toolbelts, and VA contractors should not leave available protections on the table. VA contractors, including those supplying medical devices under the MSPV-NG bridge contract and pharmaceuticals on a VA Federal Supply Schedule (“FSS”), now can negotiate for extraordinary limitations on liability (in addition to some provided by statute), among other opportunities. Particularly for contractors providing goods and services used in the COVID-19 pandemic response, it is crucial to understand both new protections available and other changes to the rules of VA contracting.
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Families First Coronavirus Response Act: Face Mask Manufacturers and Distributors Protected from Liability for Coronavirus Deaths
On March 18, 2020, the President signed into law the Families First Coronavirus Response Act, H.R. 6201, Pub. L. No. 116-127 (the “Coronavirus Response Act”). Among other measures in response to the current pandemic, this legislation offers manufacturers and distributors of industrial-grade face masks, referred to as “personal respiratory protective devices,” immunity from liability arising from use of the masks in connection with COVID-19. This immunity is retroactive to January 27, 2020, will last through October 1, 2024, and stems from the Federal Government’s effort to respond to the shortage of available masks. The law follows the Food & Drug Administration’s Emergency Use Authorization for emergency use of industrial-grade face masks in health care settings on March 2, 2020.
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Federal Circuit Changes the Game for Selling Single-API Drugs to the Government
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
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Why the Health Care Industry Should Be Concerned About Section 889 of the 2019 National Defense Authorization Act
On August 13, 2018, President Trump signed into law the National Defense Authorization Act (NDAA) of 2019. While the annual NDAAs are tracked, analyzed, and picked apart with great care
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MSPV 2.0 Is Alive
The Department of Veterans Affairs (VA) has resurrected its search for prime vendors under the Medical Surgical Prime Vendor (MSPV) 2.0 Program, re-issuing a formal solicitation on September 27, 2019. The VA canceled its original solicitation without warning on August 15, 2019.
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What’s the VA Got to Do With It? Military Medical Procurement Changes Reach the VA
There are big changes happening in military healthcare procurement. Some are unsurprising given the October 1, 2019 deadline for the reorganization of all military hospitals and clinics under the management of the Department of Defense (DOD), Defense Health Agency (DHA). But some may be unexpected, reaching all the way to Department of Veterans Affairs (VA) procurement, though the extent to which the VA will ultimately be affected is unclear. In the past few weeks, at least three major announcements were made regarding military healthcare: (1) DHA and the Defense Logistics Agency (DLA) signed a memorandum of agreement (MOA) regarding their respective rolls in DOD healthcare, (2) DLA gave the VA access to its medical/surgical prime vendor formulary indefinitely, and (3) the VA cancelled its long-anticipated prime vendor solicitation under the Medical/Surgical Prime Vendor (MSPV) 2.0 program. Is this all a coincidence? Probably not.
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VA Begins Seeking MSPV 2.0 Partners
The Department of Veterans Affairs (“VA”), Veterans Health Administration (“VHA”) has begun the move toward its new Medical/Surgical Prime Vendor (“MSPV”) 2.0 program by issuing the formal RFP seeking prime vendors for distribution and supply management services on June 3, 2019. The MSPV 2.0 program will replace the current MSPV-Next Generation program, and is designed to deliver medical, surgical, dental, and laboratory supplies to VA medical centers using a just-in-time model. Under MSPV 2.0, several prime vendors will manage distribution of some 49,000 different supplies, which they acquire from manufacturers and other suppliers, to all VA medical centers around the United States and U.S. territories. MSPV 2.0 involves three interrelated sets of agreements: (1) prime vendor IDIQs with the VA, (2) VA BPAs with suppliers, and (3) prime vendor agreements with the suppliers.
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