Legal Alerts/Details

President Trump Issues Executive Order to “Buy American” with Respect to “Essential Medicines”

August 11, 2020
Footnotes:
  1. Per Section 3(c) of the Order, the FDA Commissioner is required to publish a list of “Essential Medicines” within 90 days of the date of the Order, which may be periodically updated as appropriate.
  2. Per the Order, “Medical Countermeasures” means items that meet the definition of “qualified countermeasure” in section 247d 6a(a)(2)(A) of title 42, United States Code; “qualified pandemic or epidemic product” in section 247d–6d(i)(7) of title 42, United States Code; “security countermeasure” in section 247d–6b(c)(1)(B) of title 42, United States Code; or personal protective equipment described in part 1910 of title 29, Code of Federal Regulations.
  3. Per the Order, “Critical Inputs” means API, API Starting Material, and other ingredients of drugs and components of medical devices that the FDA Commissioner determines to be critical in assessing the safety and effectiveness of Essential Medicines and Medical Countermeasures.
  4. See the Order at Section 2(f)(i).
  5. See the Order at Section 2(f)(ii).
  6. Section 3 of the Order lists various measures in specific detail which relate to or expand upon the general notion that Agencies should conduct assessments and make recommendations to the President as to changes in law that may be necessary to identify vulnerabilities in the supply chain, to mitigate those vulnerabilities, and to generally accomplish the objectives of the Order. See the Order for a complete listing.
  7. For more information on these orders, please see https://www.npr.org/2020/07/24/895290378/trump-signs-executive-orders-on-drug-prices
  8. For more information, please see https://www.law360.com/lifesciences/articles/1299253/white-house-seeks-to-onshore-key-drug-manufacturing

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