During his first two days in office, President Biden issued 12 executive actions to address the COVID-19 pandemic, all under the umbrella of the National Strategy for the COVID-19 Response and Pandemic Preparedness issued on January 21, 2021. The Strategy aims to serve as a comprehensive roadmap to guide the U.S. out of the pandemic and is organized around the following seven goals:
- Restore trust with the American people.
- Mount a safe, effective, and comprehensive vaccination campaign.
- Mitigate spread through expanding masking, testing, data, treatments, health care workforce, and clear public health standards.
- Immediately expand emergency relief and exercise the Defense Production Act.
- Safely reopen schools, businesses, and travel while protecting workers.
- Protect those most at risk and advance equity, including across racial, ethnic, and rural/urban lines.
- Restore U.S. leadership globally and build better preparedness for future threats.
Certain elements of the Strategy will directly affect our medical product industry and especially the industry’s supply chain system:
- To make vaccines, tests, personal protective equipment (PPE), and other critical supplies available for the duration of the pandemic, the President has directed the use of all available legal authorities, including the Defense Production Act (DPA), to increase stockpiles of the products and to start to fill all supply shortfalls immediately. The federal government will focus on the near-term goal of building a stable, secure, and resilient supply chain with increased domestic manufacturing in four critical sectors:
- Antigen and molecular-based testing.
- PPE and durable medical equipment.
- Vaccine development and manufacturing.
- Therapeutics and key drugs.
- For vaccine supplies, the federal government has developed a plan for expanding vaccine manufacturing by fully leveraging contract authorities, including the DPA, and deploying onsite support to monitor contract manufacturing operations. The effort will prioritize supplies that could cause bottlenecks, including glass vials, stoppers, syringes, needles, and the “fill and finish” capacity to package vaccine into vials.
- For test supplies, the federal government will expand the rapid-testing supply and double test supplies and increase testing capacity. It plans to increase onshore test manufacturing, fill testing supply shortfalls, enhance laboratory capacity to conduct testing over the short- and long-term, and expand surveillance for hotspots and variants. In particular, the federal government will begin to exercise DPA authority to offer attractive loans to manufacturers to dramatically increase capacity in the production of COVID-19 tests.
- For future public health crises, within 180 days, the federal government will develop a new Pandemic Supply Chain Resilience Strategy to build toward a future, flexible supply chain and expand an American manufacturing capability so that the U.S. is not dependent on other countries in a crisis. Within 180 days, the federal government will also complete a review of and recommend actions to the President concerning emerging domestic and global biological risks and national biopreparedness policies to address matters including the readiness of the pandemic supply chain.
12 initial executive actions issued by the White House:
- Executive Order: Organizing and Mobilizing the United States Government to Provide a Unified and Effective Response to Combat COVID-19 and to Provide United States Leadership on Global Health and Security (January 20, 2021)
- Executive Order: Protecting the Federal Workforce and Requiring Mask-Wearing (January 20, 2021)
- Executive Order: Establishing the COVID-19 Pandemic Testing Board and Ensuring a Sustainable Public Health Workforce for COVID-19 and Other Biological Threats (January 21, 2021)
- Executive Order: Improving and Expanding Access to Care and Treatments for COVID-19 (January 21, 2021)
- Executive Order: Ensuring a Data-Driven Response to COVID-19 and Future High-Consequence Public Health Threats (January 21, 2021)
- Executive Order: A Sustainable Public Health Supply Chain (January 21, 2021)
- Executive Order: Supporting the Reopening and Continuing Operation of Schools and Early Childhood Education Providers (January 21, 2021)
- Executive Order: Protecting Worker Health and Safety (January 21, 2021)
- Executive Order: Promoting COVID-19 Safety in Domestic and International Travel (January 21, 2021)
- Executive Order: Ensuring an Equitable Pandemic Response and Recovery (January 21, 2021)
- National Security Directive: United States Global Leadership to Strengthen the International COVID-19 Response and to Advance Global Health Security and Biological Preparedness (January 21, 2021)
- Memorandum to Extend Federal Support to Governors’ Use of the National Guard to Respond to COVID-19 and to Increase Reimbursement and Other Assistance Provided to States (January 21, 2021)
In addition, on January 25, President Biden signed Executive Order: Ensuring the Future Is Made in All of America by All of America’s Workers establishing the goals and standards necessary to use federal purchasing and other forms of federal assistance with domestic preference requirements as a way to proactively invest in American industry. Notably, the Order:
- Directs an increase in both the threshold and the price preferences for domestic goods and updates how the government decides if a product was sufficiently made in America.
- Creates a central review of agency waivers of Buy American requirements and directs the General Services Administration to publish relevant waivers on a publicly available website.
- Requires agencies to biannually report on their implementation of current Made in America laws and make recommendations for achieving the President’s Made in America goals.
Many parts of the Strategy and the Buy American Order still lack details for implementation. Given the urgency to control the COVID-19 spread and support the domestic economy, we expect more executive actions coming in the near future. Please do not hesitate to reach out to us if you have any questions about the Strategy, the Buy American Order, and relevant executive actions.