Buy American panel discussion: How will this month's Executive Order impact drug and device companies, and what should you do about it?

On August 6, 2020, U.S. President Donald Trump issued his much-anticipated "Buy American" Executive Order (EO), aimed at shoring up domestic manufacture of "essential medicines", "medical countermeasures", and "critical inputs" (API and other raw materials), and decreasing dependency on non-domestic sources. Coming on the heels of multiple legislative proposals with similar focus, the EO would streamline regulatory processes and apply preferences to domestic products in Federal procurements.

Important questions about how the EO will be implemented make it impossible to predict its precise impact. Certain things are clear, however, including the potential for major disruptions to trade relations and Federal procurement. Given the uncertainty, the nature, and magnitude of the potential effects – both in the U.S. and abroad – require attention and strategic thought now.

With that in mind, members of the Hogan Lovells Life Sciences team held a lively discussion on the “Buy American” EO on August 20, 2020. Senior practitioners with experience in Government Contracts, International Trade, Government Relations, regulation of the Pharma/Biotech, and Medical Device industries talked about what they’re seeing, what they expect, and what actions companies are – or should be – taking or considering. Among the questions, we discussed:

  • What does the EO purport to achieve, and what is required to implement it?
  • What kinds of drugs and devices are expected to be covered under the EO as medically necessary?
  • What are the procurement implications for a drug or device deemed medically necessary?
  • What Federal agencies and health programs fall under the EO, and what are the likely effects on the agencies’ ability to meet their missions?
  • How will U.S. production/origin be assessed under the EO?
  • Will the EO result in greater use of the Defense Production Act and other emergency government procurement tools?
  • What exceptions to the Buy American requirements are available, and what impact will they have on implementation?
  • What could the EO mean in terms of U.S. commitments under international trade agreements?
  • What are the potential impacts in foreign markets – specifically with respect to foreign government procurements?
  • What are the possible implications on exports?
  • How can FDA reduce barriers to domestic production under the terms of the EO?
  • What impact should we expect the EO to have on FDA inspections?
  • If your company is impacted by the EO, what are the next steps?

Watch here

Read about the “Buy American” EO here


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