HIDA Government Affairs Alert

August 7, 2020

New Executive Order Requires Domestic Manufacturing Of Medical Supplies

An Executive Order signed last night by President Trump aims to boost onshore manufacturing of essential medicines, medical countermeasures, and critical inputs in addition to identifying vulnerabilities within the supply chains for these products.

The order directs federal agencies to allow only U.S. producers to bid on related federal contracts. At least two manufacturers must ultimately be awarded contracts.

The order includes a number of exceptions that could shape how the final policy is implemented:

  • If the agency determines that this requirement would be inconsistent with the public interest,
  • If the relevant products are not produced in the U.S. in sufficient and reasonably available commercial quantities or of satisfactory quality,
  • If domestic procurement would increase price by more than 25%,
  • If procurement of specified items are necessary to respond to any public health emergency

Under the required supply chain vulnerability assessment, the HHS Secretary shall take appropriate action to accelerate FDA approval for domestic producers, issue guidance for the development of Advanced Manufacturing techniques, and negotiate with foreign countries to increase inspections of manufacturing facilities.

Further, as a result of the assessment, recommendations will be made to the President for any changes in applicable law while existing regulations will be reviewed to determine whether they are preventing domestic manufacturing capabilities.

The list of products included under the executive order must be determined within 90 days by the FDA Commissioner, Director of the Office of Management and Budget (OMB), the Assistant Secretary for Preparedness and Response (ASPR), the Assistant to the President for Economic Policy, and the Director of the Office of Trade and Manufacturing Policy.

Please feel free to reach out to us with any questions at HIDAGovAffairs@HIDA.org or 703-549-4432.