Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States
| Published date | 14 August 2020 |
| Citation | 85 FR 49929 |
| Record Number | 2020-18012 |
| Section | Presidential Documents |
| Court | Executive Office Of The President |
Federal Register, Volume 85 Issue 158 (Friday, August 14, 2020)
[Federal Register Volume 85, Number 158 (Friday, August 14, 2020)]
[Presidential Documents]
[Pages 49929-49934]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18012]
[[Page 49927]]
Vol. 85
Friday,
No. 158
August 14, 2020
Part VII
The President
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Executive Order 13944--Combating Public Health Emergencies and
Strengthening National Security by Ensuring Essential Medicines,
Medical Countermeasures, and Critical Inputs Are Made in the United
States
Executive Order 13945--Fighting the Spread of COVID-19 by Providing
Assistance to Renters and Homeowners
Notice of August 13, 2020--Continuation of the National Emergency With
Respect to Export Control Regulations
Presidential Documents
Federal Register / Vol. 85, No. 158 / Friday, August 14, 2020 /
Presidential Documents
___________________________________________________________________
Title 3--
The President
[[Page 49929]]
Executive Order 13944 of August 6, 2020
Combating Public Health Emergencies and
Strengthening National Security by Ensuring Essential
Medicines, Medical Countermeasures, and Critical Inputs
Are Made in the United States
By the authority vested in me as President by the
Constitution and the laws of the United States of
America, it is hereby ordered as follows:
Section 1. Policy. The United States must protect our
citizens, critical infrastructure, military forces, and
economy against outbreaks of emerging infectious
diseases and chemical, biological, radiological, and
nuclear (CBRN) threats. To achieve this, the United
States must have a strong Public Health Industrial Base
with resilient domestic supply chains for Essential
Medicines, Medical Countermeasures, and Critical Inputs
deemed necessary for the United States. These domestic
supply chains must be capable of meeting national
security requirements for responding to threats arising
from CBRN threats and public health emergencies,
including emerging infectious diseases such as COVID-
19. It is critical that we 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, to minimize potential shortages, and
to mobilize our Nation's Public Health Industrial Base
to respond to these threats. It is therefore the policy
of the United States to:
(a) accelerate the development of cost-effective
and efficient domestic production of Essential
Medicines and Medical Countermeasures and have adequate
redundancy built into the domestic supply chain for
Essential Medicines, Medical Countermeasures, and
Critical Inputs;
(b) ensure long-term demand for Essential
Medicines, Medical Countermeasures, and Critical Inputs
that are produced in the United States;
(c) create, maintain, and maximize domestic
production capabilities for Critical Inputs, Finished
Drug Products, and Finished Devices that are essential
to protect public safety and human health and to
provide for the national defense; and
(d) combat the trafficking of counterfeit Essential
Medicines, Medical Countermeasures, and Critical Inputs
over e-commerce platforms and from third-party online
sellers involved in the government procurement process.
I am therefore directing each executive department and
agency involved in the procurement of Essential
Medicines, Medical Countermeasures, and Critical Inputs
(agency) to consider a variety of actions to increase
their domestic procurement of Essential Medicines,
Medical Countermeasures, and Critical Inputs, and to
identify vulnerabilities in our Nation's supply chains
for these products. Under this order, agencies will
have the necessary flexibility to increase their
domestic procurement in appropriate and responsible
ways, while protecting our Nation's service members,
veterans, and their families from increases in drug
prices and without interfering with our Nation's
ability to respond to the spread of COVID-19.
Sec. 2. Maximizing Domestic Production in Procurement.
(a) Agencies shall, as appropriate, to the maximum
extent permitted by applicable law, and in consultation
with the Commissioner of Food and Drugs (FDA
Commissioner) with respect to Critical Inputs, use
their respective authorities under section 2304(c) of
title 10, United States Code; section 3304(a) of title
41,
[[Page 49930]]
United States Code; and subpart 6.3 of the Federal
Acquisition Regulation, title 48, Code of Federal
Regulations, to conduct the procurement of Essential
Medicines, Medical Countermeasures, and Critical Inputs
by:
(i) using procedures to limit competition to only those Essential
Medicines, Medical Countermeasures, and Critical Inputs that are produced
in the United States; and
(ii) dividing procurement requirements among two or more manufacturers
located in the United States, as appropriate.
(b) Within 90 days of the date of this order, the
Director of the Office of Management and Budget (OMB),
in consultation with appropriate agency heads, shall:
(i) review the authority of each agency to limit the online procurement of
Essential Medicines and Medical Countermeasures to e-commerce platforms
that have:
(A) adopted, and certified their compliance with, the applicable best
practices published by the Department of Homeland Security in its Report to
the President on ``Combating Trafficking in Counterfeit and Pirated
Goods,'' dated January 24, 2020; and
(B) agreed to permit the Department of Homeland Security's National
Intellectual Property Rights Coordination Center to evaluate and confirm
their compliance with such best practices; and
(ii) report its findings to the President.
(c) Within 90 days of the date of this order, the
head of each agency shall, in consultation with the FDA
Commissioner, develop and implement procurement
strategies, including long-term contracts, consistent
with law, to strengthen and mobilize the Public Health
Industrial Base in order to increase the manufacture of
Essential Medicines, Medical Countermeasures, and
Critical Inputs in the United States.
(d) No later than 30 days after the FDA
Commissioner has identified, pursuant to section 3(c)
of this order, the initial list of Essential Medicines,
Medical Countermeasures, and Critical Inputs, the
United States Trade Representative shall, to the extent
permitted by law, take all appropriate action to modify
United States Federal procurement product coverage
under all relevant Free Trade Agreements and the World
Trade Organization Agreement on Government Procurement
to exclude coverage of Essential Medicines, Medical
Countermeasures, and Critical Inputs. The United States
Trade Representative shall further modify United States
Federal procurement product coverage, as appropriate,
to reflect updates by the FDA Commissioner. After the
modifications to United States Federal procurement
coverage take effect, the United States Trade
Representative shall make any necessary, corresponding
modifications of existing waivers under section 301 of
the Trade Agreements Act of 1979. The United States
Trade Representative shall notify the President,
through the Director of OMB, once it has taken the
actions described in this subsection.
(e) No later than 60 days after the FDA
Commissioner has identified, pursuant to section 3(c)
of this order, the initial list of Essential Medicines,
Medical Countermeasures, and Critical Inputs, and
notwithstanding the public interest exception in
subsection (f)(i)(1) of this section, the Secretary of
Defense shall, to the maximum extent permitted by
applicable law, use his authority under section
225.872-1(c) of the Defense Federal Acquisition
Regulation Supplement to restrict the procurement of
Essential Medicines, Medical Countermeasures, and
Critical Inputs to domestic sources and to reject
otherwise acceptable offers of such products from
sources in Qualifying Countries in instances where
considered necessary for national defense reasons.
(f) Subsections (a), (d), and (e) of this section
shall not apply:
[[Page 49931]]
(i) where the head of the agency determines in writing, with respect to a
specific contract or order, that (1) their application would be
inconsistent with the public interest; (2) the relevant Essential
Medicines, Medical Countermeasures, and Critical Inputs are not produced in
the United States in sufficient and reasonably available commercial
quantities and of a satisfactory quality; or (3) their application would
cause the cost of the procurement to increase by more than 25 percent,
unless applicable law requires a higher percentage, in which case such
higher percentage shall apply;
(ii) with respect to the procurement of items that are necessary to respond
to any public health emergency declared under section 319 of the Public
Health Service Act (42 U.S.C. 247d), any major disaster or emergency
declared under the Stafford Disaster Relief and Emergency Assistance Act
(42 U.S.C. 5121 et seq.), or any national emergency declared under the
National Emergencies Act (50 U.S.C. 1601 et seq.).
(g) To the maximum extent permitted by law, any
public interest determination made pursuant to section
2(f)(i)(1) of this order shall be construed to maximize
the procurement and use of Essential Medicines and
Medical Countermeasures produced in the United States.
(h) The head of an agency who makes any
determination pursuant to section 2(f)(i) of this order
shall submit an annual report to the President, through
the Director of OMB and the Assistant to the President
for Trade and Manufacturing Policy, describing the
justification for each such determination.
Sec. 3. Identifying Vulnerabilities in Supply Chains.
(a) Within 180 days of the date of this order, the
Secretary of Health and Human Services, through the FDA
Commissioner and in consultation with the Director of
OMB, shall take all necessary and appropriate action,
consistent with law, to identify vulnerabilities in the
supply chain for Essential Medicines, Medical
Countermeasures, and Critical Inputs and to mitigate
those vulnerabilities, including by:
(i) considering proposing regulations or revising guidance on the
collection of the following information from manufacturers of Essential
Medicines and Medical Countermeasures as part of the application and
regulatory approval process:
(A) the sources of Finished Drug Products, Finished Devices, and Critical
Inputs;
(B) the use of any scarce Critical Inputs; and
(C) the date of the last FDA inspection of the manufacturer's regulated
facilities and the results of such inspection;
(ii) entering into written agreements, pursuant to section 20.85 of title
21, Code of Federal Regulations, with the National Security Council,
Department of State, Department of Defense, Department of Veterans Affairs,
and other interested agencies, as appropriate, to disclose records
regarding the security and vulnerabilities of the supply chains for
Essential Medicines, Medical Countermeasures, and Critical Inputs;
(iii) recommending to the President any changes in applicable law that may
be necessary to accomplish the objectives of this subsection; and
(iv) reviewing FDA regulations to determine whether any of those
regulations may be a barrier to domestic production of Essential Medicines,
Medical Countermeasures, and Critical Inputs, and by advising the President
whether such regulations should be repealed or amended.
(b) The Secretary of Health and Human Services,
through the FDA Commissioner, shall take all
appropriate action, consistent with applicable law, to:
(i) accelerate FDA approval or clearance, as appropriate, for domestic
producers of Essential Medicines, Medical Countermeasures, and Critical
[[Page 49932]]
Inputs, including those needed for infectious disease and CBRN threat
preparedness and response;
(ii) issue guidance with recommendations regarding the development of
Advanced Manufacturing techniques;
(iii) negotiate with countries to increase site inspections and increase
the number of unannounced inspections of regulated facilities manufacturing
Essential Medicines, Medical Countermeasures, and Critical Inputs; and
(iv) refuse admission, as appropriate, to imports of Essential Medicines,
Medical Countermeasures, and Critical Inputs if the facilities in which
they are produced refuse or unreasonably delay an inspection.
(c) Within 90 days of the date of this order, and
periodically updated as appropriate, the FDA
Commissioner, in consultation with the Director of OMB,
the Assistant Secretary for Preparedness and Response
in the Department of Health and Human Services, the
Assistant to the President for Economic Policy, and the
Director of the Office of Trade and Manufacturing
Policy, shall identify the list of Essential Medicines,
Medical Countermeasures, and their Critical Inputs that
are medically necessary to have available at all times
in an amount adequate to serve patient needs and in the
appropriate dosage forms.
(d) Within 180 days of the date of this order, the
Secretary of Defense, in consultation with the Director
of OMB, shall take all necessary and appropriate
action, consistent with law, to identify
vulnerabilities in the supply chain for Essential
Medicines, Medical Countermeasures, and Critical Inputs
necessary to meet the unique needs of the United States
Armed Forces and to mitigate the vulnerabilities
identified in subsection (a) of this section. The
Secretary of Defense shall provide to the Secretary of
Health and Human Services, the FDA Commissioner, the
Director of OMB, and the Director of the Office of
Trade and Manufacturing Policy a list of defense-
specific Essential Medicines, Medical Countermeasures,
and Critical Inputs that are medically necessary to
have available for defense use in adequate amounts and
in appropriate dosage forms. The Secretary of Defense
shall, as appropriate, periodically update this list.
Sec. 4. Streamlining Regulatory Requirements.
Consistent with law, the Administrator of the
Environmental Protection Agency shall take all
appropriate action to identify relevant requirements
and guidance documents that can be streamlined to
provide for the development of Advanced Manufacturing
facilities and the expeditious domestic production of
Critical Inputs, including by accelerating siting and
permitting approvals.
Sec. 5. Priorities and Allocation of Essential
Medicines, Medical Countermeasures, and Critical
Inputs. The Secretary of Health and Human Services
shall, as appropriate and in accordance with the
delegation of authority under Executive Order 13603 of
March 16, 2012 (National Defense Resources
Preparedness), use the authority under section 101 of
the Defense Production Act of 1950, as amended (50
U.S.C. 4511), to prioritize the performance of Federal
Government contracts or orders for Essential Medicines,
Medical Countermeasures, or Critical Inputs over
performance of any other contracts or orders, and to
allocate such materials, services, and facilities as
the Secretary deems necessary or appropriate to promote
the national defense.
Sec. 6. Reporting. (a) No later than December 15, 2021,
and annually thereafter, the head of each agency shall
submit a report to the President, through the Director
of OMB and the Assistant to the President for Trade and
Manufacturing Policy, detailing, for the preceding
three fiscal years:
(i) the Essential Medicines, Medical Countermeasures, and Critical Inputs
procured by the agency;
(ii) the agency's annual itemized and aggregated expenditures for all
Essential Medicines, Medical Countermeasures, and Critical Inputs;
(iii) the sources of these products and inputs; and
[[Page 49933]]
(iv) the agency's plan to support domestic production of such products and
inputs in the next fiscal year.
(b) Within 180 days of the date of this order, the
Secretary of Commerce shall submit a report to the
Director of OMB, the Assistant to the President for
National Security Affairs, the Director of the National
Economic Council, and the Director of the Office of
Trade and Manufacturing Policy, describing any change
in the status of the Public Health Industrial Base and
recommending initiatives to strengthen the Public
Health Industrial Base.
(c) To the maximum extent permitted by law, and
with the redaction of any information protected by law
from disclosure, each agency's report shall be
published in the Federal Register and on each agency's
official website.
Sec. 7. Definitions. As used in this order:
(a) ``Active Pharmaceutical Ingredient'' has the
meaning set forth in section 207.1 of title 21, Code of
Federal Regulations.
(b) ``Advanced Manufacturing'' means any new
medical product manufacturing technology that can
improve drug quality, address shortages of medicines,
and speed time to market, including continuous
manufacturing and 3D printing.
(c) ``API Starting Material'' means a raw or
intermediate material that is used in the manufacturing
of an API, that is incorporated as a significant
structural fragment into the structure of the API, and
that is determined by the FDA Commissioner to be
relevant in assessing the safety and effectiveness of
Essential Medicines and Medical Countermeasures.
(d) ``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.
(e) ``Essential Medicines'' are those Essential
Medicines deemed necessary for the United States
pursuant to section 3(c) of this order.
(f) ``Finished Device'' has the meaning set forth
in section 820.3(l) of title 21, Code of Federal
Regulations.
(g) ``Finished Drug Product'' has the meaning set
forth in section 207.1 of title 21, Code of Federal
Regulations.
(h) ``Healthcare and Public Health Sector'' means
the critical infrastructure sector identified in
Presidential Policy Directive 21 of February 12, 2013
(Critical Infrastructure Security and Resilience), and
the National Infrastructure Protection Plan of 2013.
(i) An Essential Medicine or Medical Countermeasure
is ``produced in the United States'' if the Critical
Inputs used to produce the Essential Medicine or
Medical Countermeasures are produced in the United
States and if the Finished Drug Product or Finished
Device, are manufactured, prepared, propagated,
compounded, or processed, as those terms are defined in
section 360(a)(1) of title 21, United States Code, in
the United States.
(j) ``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.
(k) ``Public Health Industrial Base'' means the
facilities and associated workforces within the United
States, including research and development facilities,
that help produce Essential Medicines, Medical
Countermeasures, and Critical Inputs for the Healthcare
and Public Health Sector.
(l) ``Qualifying Countries'' has the meaning set
forth in section 225.003, Defense Federal Acquisition
Regulation Supplement.
[[Page 49934]]
Sec. 8. Rule of Construction. Nothing in this order
shall be construed to impair or otherwise affect:
(a) the ability of State, local, tribal, or
territorial governments to timely procure necessary
resources to respond to any public health emergency
declared under section 319 of the Public Health Service
Act (42 U.S.C. 247d), any major disaster or emergency
declared under the Stafford Act (42 U.S.C. 5121 et
seq.), or any national emergency declared under the
National Emergencies Act (50 U.S.C. 1601 et seq.);
(b) the ability or authority of any agency to
respond to the spread of COVID-19; or
(c) the authority of the Secretary of Veterans
Affairs to take all necessary steps, including those
necessary to implement the policy set forth in section
1 of this order, to ensure that service members,
veterans, and their families continue to have full
access to Essential Medicines at reasonable and
affordable prices.
Sec. 9. Severability. If any provision of this order,
or the application of any provision to any person or
circumstance, is held to be invalid, the remainder of
this order and the application of any of its other
provisions to any other persons or circumstances shall
not be affected thereby.
Sec. 10. General Provisions. (a) Nothing in this order
shall be construed to impair or otherwise affect:
(i) the authority granted by law to an executive department or agency, or
the head thereof; or
(ii) the functions of the Director of OMB relating to budgetary,
administrative, or legislative proposals.
(b) This order shall be implemented consistent with
applicable law and subject to the availability of
appropriations.
(c) This order is not intended to, and does not,
create any right or benefit, substantive or procedural,
enforceable at law or in equity by any party against
the United States, its departments, agencies, or
entities, its officers, employees, or agents, or any
other person.
(Presidential Sig.)
THE WHITE HOUSE,
August 6, 2020.
[FR Doc. 2020-18012
Filed 8-13-20; 11:15 am]
Billing code 3295-F0-P
