On August 6, 2020, President Trump signed an Executive Order to boost domestic production of pharmaceuticals, Active Pharmaceutical Ingredients, and personal protective equipment (PPE), and declaring the reduction of dependence on foreign manufacturers of these products to be “critical” to the nation. The Executive Order provides:
- 1. Federal agencies are required to purchase Essential Medicines, Medical Countermeasures, and Critical Inputs that are produced in the United States;
- 2. The FDA is required to identify regulations that can be streamlined to eliminate barriers to domestic production of these products.
The Executive Order charges the Secretary of Health and Human Services with prioritizing production of these materials pursuant to the Defense Production Act. Exceptions to this Executive Order are provided based on cost, availability and “public interest,” but such exceptions must be justified on an annual basis.
We continue to monitor federal, state, and local governments that are implementing incentives to encourage increased domestic production of critical supplies, or to prohibit the use of products deemed an economic or national security concern. SGR will release further guidance as warranted. If you have specific questions, please contact Peter Crofton or Greg Smith for more questions.