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Executive order on ensuring essential medicines are made in the U.S.

By Natalia Mazina on August 24, 2020

This month, President Trump signed an executive order mandating that certain drugs and medical supplies purchased by federal agencies are U.S.-manufactured. The objective of the order is to reduce our dependence on foreign manufacturers for “Essential Medicines, Medical Countermeasures, and Critical Inputs” to ensure sufficient and reliable long-term domestic production of these products. The order is apparently aimed at plugging gaps in the medical supply chain that have been revealed during the coronavirus crisis.

(By the way, if you are wondering what constitutes “Essential Medicines, Medical Countermeasures, and Critical Inputs,” you are not the only one. Currently, we are waiting for a definition from the FDA.)

The order mandates that within 180 days of its date, the Secretary of Health and Human Services identifies vulnerabilities in the supply chain for “Essential Medicines, Medical Countermeasures, and Critical Inputs and to mitigate those vulnerabilities.”

The potential impact of this order is still unclear. But the effect could be very substantial. To remind, the U.S. currently imports approximately 80% of active pharmaceutical ingredients. Critics argue that the quality of medication could potentially decrease while the cost is likely to rise. Some trade organizations are also worried that the order will cause a disruption in the supply chain, including causing a shift in manufacturers’ priorities taking vulnerable resources away from the priority of combating the COVID-19 outbreak.

 

 

  • Posted in:
    Health Care
  • Blog:
    Pharmacy & Healthcare Legal Blog
  • Organization:
    Mazina Law
  • Article: View Original Source

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