By the authority conferred on me as President through the Constitution and that of the United States of America, it is ordained as follows:
Section 1. Policy. The United States will have to protect our citizens, critical infrastructure, the armed forces, and the economy from outbreaks of emerging infectious diseases and chemical, biological, radiological, and nuclear (QBRN) threats. To achieve this, the United States will need to have a strong commercial public fitness base with chains of resistant domestic sources for essential drugs, medical countermeasures, and critical supplies considered mandatory in the United States. These national source chains should be able to meet national security needs to respond to threats arising from QBRN threats and public fitness emergencies, adding emerging infectious diseases such as COVID-19. It is imperative that we reduce our reliance on foreign brands for essential medicines, medical countermeasures and critical inputs to ensure sufficient and reliable long-term domestic production of these products, minimize potential shortages, and mobilize our public fitness base in the country to respond to these threats. Therefore, it is U.S. policy:
(a) drive the progression of cost-effective and cost-effective domestic production of medicines and medical countermeasures and integrate sufficiently good redundancy into the national supply chain of medicines, medical countermeasures and critical supplies;
(b) ensure long-term demand for medicines, medical countermeasures and critical supplies produced in the United States;
(c) create and maximize the domestic production capacity of critical inputs, finished prescription drugs and terminated devices that are essential to protect public protection and human fitness and to make some national defence; And
(d) combat the trafficking of counterfeit drugs, medical countermeasures and critical inputs on e-commerce platforms and third-party online distributors involved in the procurement process.
Therefore, I ask each and every executive branch and companies interested in acquiring essential medicines, medical countermeasures and critical inputs (company) to a variety of movements to develop their national procurement of essential medicines, medical counter. critical measures and inputs, and identify vulnerabilities in our nation’s chains of origin for those products. Under this ordinance, agencies will have the flexibility to develop their national procurement appropriately and responsibly, while protecting our nation’s service members, veterans, and their families from worthwhile drug accumulations and without interfering with our nation’s ability to respond to the spread. COVID-19.
Second. 2. Maximize domestic production in acquisitions. (a) Agencies should, where appropriate, to the maximum extent permitted by applicable law, and in consultation with the Food and Drug Commissioner (FDA Commissioner) with respect to critical inputs, use their respective powers under Section 2304(c) of the Title. 10, U.S. Code; Section 3304(a) Title 41, United States Code; and Sub-Part 6.3 of the Federal Procurement Regulations, Title 48, Code of Federal Regulations, to acquire medicines, medical countermeasures and critical supplies through:
(i) use procedures to restrict the festival to drugs, medical countermeasures and critical inputs produced in the United States; And
(ii) divide the acquisition between two or more U.S. manufacturers, as appropriate.
(b) Within days of the date of this order, the Director of the Office of Administration and Budget (OMB), in consultation with the heads of the relevant agencies, must:
(i) review the firm’s strength to restrict the online acquisition of mandatory drugs and medical countermeasures to e-commerce platforms that have:
(A) continued and qualified its compliance with applicable practices published through the Department of Homeland Security in its report to the President on “Combating Trafficking in Counterfeit and Pirated Goods”, dated 24 January 2020; And
(B) agreed to allow the National Intellectual Property Protection Center of the Department of Homeland Security to evaluate and verify its compliance with these practices; And
(ii) its conclusions to the President.
(c) Within 90 days of the date of this order, the head of each agency, in consultation with the FDA Commissioner, develops and implements procurement strategies, adding long-term contracts, in accordance with the law, and mobilizing public health. . Industrial base to build 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, in accordance with Article 3(c) of this order, the initial list of drugs, medical countermeasures and critical supplies, the U.S. Trade Representative must, to the extent legal through law, take all appropriate steps to adjust the U.S. federal product acquisition policy under all applicable applicable applicable industrial loose agreements under all applicable applicable industrial loose agreements under all applicable applicable applicable industrial loose agreements. and the World Organization Agreement. procurement to exclude drug policy, medical countermeasures and critical inputs. The U.S. Trade Representative It will also amend the U.S. federal government’s product acquisition policy, if applicable, to reflect updates from the FDA Commissioner. Once adjustments to the U.S. federal government’s procurement policy take effect, the U.S. Trade Representative. It will make all mandatory adjustments for the exemptions existing under Section 301 of the Trade Agreements Act 1979. The U.S. Trade Representative You will inform the President, through the OMB Administrator, once you have taken the steps described in this subsection.
(e) No later than 60 days after the FDA Commissioner has identified, in accordance with Section 3(c) of this order, the initial list of mandatory drugs, medical countermeasures and critical supplies, and without prejudice to the public interest exception in paragraph (f)(i) (1) of this article, the Secretary of Defense shall, to the maximum extent permitted by applicable law, , Array use its authority under Section 225.872-1 (c) of the Federal Defense Supplement. Acquisition Regulation to limit the procurement of essential medicines, medical countermeasures and critical inputs of national resources and to reject differently the appropriate offers of those resource products located in eligible countries where this is considered mandatory for national defence reasons.
(f) Paragraphs (a), (d) and (e) of this Article apply:
(i) where the director of the signature determines in writing, in connection with a contract or express order, that (1) its application would be inconsistent with the public interest; (2) essential medicines, medical countermeasures and applicable critical supplies are not produced in the United States in sufficient quantity and, rather, are marketed in acceptable quality quantities; or (3) its application would result in a market-held accumulation of more than 25 cents, unless the applicable law requires a consistent percentage, in which case this consistent percentage shall be applied;
(ii) with respect to the acquisition of parts to respond to any public fitness emergency declared under Section 319 of the Public Health Service Act (42 USC 247d), any primary or emergency crisis declared under the Stafford Emergency Assistance and Disaster Relief Act (42 USC 5121 and below.), OR any national emergency declared under the National Emergency Act (50 USC 1601 and the following).
(g) To the greatest extent of the law, any public interest determination made pursuant to Section 2(f) (i) (i) (1) of this order shall be construed to maximize the acquisition and use of an obligation: to have medicinal products and medical countermeasures produced in the United States.
(h) The head of a firm that makes a resolution under Section 2(f) (i) (i) (i) of this order shall submit an annual report to the President, through the Director of the OMB and the Assistant To Trade of the President and Manufacturing Policy. Matrix describing the basis of each of these determinations.
Second. 3. Identify vulnerabilities in font strings. (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 the OMB, will take all mandatory and appropriate measures, in accordance with the law, to identify and mitigate vulnerabilities in the chain of origin of drugs, medical countermeasures and critical supplies.
(i) propose regulations or revise the direction on the collection of the following data from brands of essential medicines and medical countermeasures as a component of the regulatory approval and enforcement process:
(A) resources for finished pharmaceuticals, devices and finished inputs;
(B) the use of all infrequent inputs; And
(C) the date of the FDA’s last inspection of the manufacturer’s regulated services and the effects of that inspection;
(ii) contributions to written agreements, in accordance with Section 20.85 of Title 21, Code of Federal Regulations, with the National Security Council, the Department of State, the Department of Defense, the Department of Veterans Affairs and other interested agencies, as appropriate, disclose protection records and vulnerability of the source chain for drugs, medical countermeasures and critical inputs;
(iii) make any adjustment to the applicable law that may be necessary to achieve the objectives of this paragraph to the Presidency; And
(iv) review FDA regulations to determine whether any of these regulations could be a barrier to domestic production of essential drugs, medical countermeasures, and critical supplies, and tell the president whether those regulations want to be repealed or amended.
(b) The Secretary of Health and Human Services, the FDA Commissioner, will take all appropriate measures, in accordance with applicable law, to:
(i) expedite FDA approval or approval, as appropriate, for domestic manufacturers of medicines, medical countermeasures and critical supplies, adding those necessary to prepare for and respond to infectious diseases and QBRN threats;
(ii) steering factor with recommendations for the progression of complex production techniques;
(iii) negotiate with countries to strengthen inspections and increase the number of un announced inspections of regulated services, the production of essential medicines, medical countermeasures and critical inputs; And
(iv) refuse admission, if any, to imports of medicinal products, medical countermeasures and critical supplies if the services in which they occur are unreasonably refused or delayed an inspection.
(c) Within 90 days of the date of this order, and periodically updated if required, the FDA Commissioner, in consultation with the Director of the WMO, the Under-Secretary of Preparation and Intervention of the Department of Health and Human Services, the Assistant President of Economic Policy and the Director of the Office of Trade and Manufacturing Policy shall identify the list of medical countermeasures and critical supplies of a matrix of essential drugs are medically mandatory at all times in sufficient quantities to care for the patient. desires and appropriate dosage forms.
(d) Within 180 days of the date of this order, the Secretary of Defense, in consultation with the Director of the WMO, takes all mandatory and appropriate measures, in accordance with the law, to identify vulnerabilities in the chain of origin of medicines. countermeasures and mandatory inputs to satisfy the exclusive wishes of the United States military and to mitigate the vulnerabilities known in paragraph (a). The Secretary of Defense will provide the Secretary of Health and Human Services, the FDA Commissioner, the Director of the OMB and the Director of the Office of Trade and Manufacturing Policy with a list of drugs, medical countermeasures and critical defense inputs. it is medically mandatory to eliminate it for defense purposes in sufficiently good amounts and in appropriate dosage forms. The Secretary of Defense shall periodically update this list, if required.
Second. 4. Rationalization of regulatory needs. According to the law, the Administrator of the Environmental Protection Agency takes all appropriate measures to identify applicable needs and steering documents that can be simplified to allow the progression of complex production amenities and immediate domestic production of critical inputs, adding variety and acceleration. allow approvals.
Second. 5. Priorities and allocation of essential medicines, medical countermeasures and critical supplies. The Secretary of Health and Human Services shall, where appropriate and in accordance with the delegation of forces under Decree 13603 of March 16, 2012 (Preparation of National Defense Resources), use force under segment 101 of the Defense Production Act of 1950, (50 USC 4511), to prioritize the functionality of federal government contracts or orders for essential drugs Fix medical countermeasures or critical supplies in relation to the functionality of any other contract or order, and to assign materials and services that the Secretary deems obligatory or convenient to publicize the national defense.
Second. 6. Reports. (a) No later than 15 December 2021 and one year later, the head of the firm shall submit a report to the President, through the Director of the WMO and the Assistant President of Trade and Manufacturing Policy, detailing the 3 exercises:
(i) medicines, medical countermeasures and critical supplies purchased through the agency;
(ii) the agency’s detailed and aggregate annual expenditures for all medicines, medical countermeasures and critical supplies;
(iii) the resources of these and inputs; And
(iv) the agency’s plan for the domestic production of these 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 the WMO, the Assistant President for National Security Affairs, the Director of the National Economic Council and the Director of the Office of Trade and Manufacturing Policy, which describes any adjustment in the prestige of the commercial public fitness base and recommends projects to the commercial public fitness base.
(c) To the extent permitted by law, and with the preparation of any data through disclosure, the report of each agency will be published in the Federal Register and on the official website of each agency.
Second. 7. Definitions. As used in this order:
(a) “Active Pharmaceutical Ingredient” is given to Section 207.1 of Title 21, Code of Federal Regulations.
(b) “Advanced Manufacturing” refers to any new generation for the production of medical products that can improve the quality of medicines, address drug shortages and boost marketing, adding uninterrupted production and 3D printing.
(c) “API Starting Material” means intermediate or raw curtains used in the manufacture of an API, which is incorporated as a significant structural fragment in the API design, and is applicable through the FDA Commissioner to evaluate the protection and efficacy of essential medicines and medical countermeasures.
(d) “Critical supplies” means the API, the initial API for curtains, and other ingredients in medications and parts of medical devices that the FDA Commissioner considers to evaluate the protection and efficacy of medications and medical countermeasures.
(e) “Essential Medicines” are medicines that are considered mandatory in the United States pursuant to Section 3(c) of this prescription.
(f) “Device terminated” has as set out in Section 820.3 (l) of Title 21, Code of Federal Regulations.
(g) “Finished Pharmaceutical Product” is Title 207.1, Code of Federal Regulations.
(h) “Health and Public Health Sector” refers to the infrastructure sector known in the Presidential Directive 21 of 12 February 2013 (infrastructure security and resilience) and the 2013 National Infrastructure Protection Plan.
(i) A medical drug or countermeasure is “produced in the United States” if critical inputs used to produce the drug or medical countermeasures are produced in the United States and if the finished pharmaceutical product or finished device is manufactured, prepared, reproduced, composed, or processed, as explained in Section 360(a)(1) of Title 21, United States CodeArray in the United States.
(j) “Medical Countermeasures” means articles that meet the definition of “eligible countermeasure” in Section 247d 6a(a) (a) (2) (A) of Title 42 of the United States Code; “Qualified Pandemic or Epidemic Product” in Section 247d – 6d (i) (7) of Title 42 of the United States Code; “Security Countermeasure” in Section 247d – 6b(c) (1) (B) of Title 42, United States Code; or non-public apparatus described in the 1910 component of Title 29, Code of Federal Regulations.
(k) “Industrial Public Health Base” refers to the amenities and body of related workers in the United States, adding studies and amenities of progression, which help produce essential medicines, medical countermeasures and critical supplies for the public fitness and fitness sector.
(l) “Eligible Countries” has the indicated segment 225.003, Supplement to the Federal Defense Procurement Regulations.
Second. 8. Construction rule. Nothing in this order deserves to be interpreted as an offender or that affects differently:
(a) the ability of state, local, tribal or territorial governments to obtain timely resources to respond to any public fitness emergency stated in Section 319 of the Public Health Service Act (42 USC 247d), to any primary or emergency crisis declared by Stafford Act (42 USC 5121 and below). Array or any national emergency declared as the National Emergency Act (50 USC 1601 and below.
(b) the ability or authority of any signature to respond to COVID-19; Yes
(c) the Secretary of Veterans Affairs’ force to take all mandatory steps, adding the necessary measures to enforce the policy set forth in segment 1 of this ordinance, to ensure that members, veterans, and their families continue to have full Essential Drugs at moderate and affordable prices.
Second. 9. Divisibility. If a provision of this order, or the application of a provision to a user or circumstance, is found to be invalid, the remainder of this order and the application of any of its other provisions to any other user or circumstance will be affected.
Second. 10. General Provisions. (a) Nothing in this order deserves to be construed as an infringement or that in a different way affects:
(i) the legal authority granted to a branch or agency, or its director; Yes
(ii) the purposes of the Director of the WMO in relation to budgetary, administrative or legislative proposals.
(b) This order is carried out in accordance with the law and subject to the availability of credits.
(c) This order does not create or create any substantive or procedural rights or obtain benefits enforceable by law or justice through any party that objects to the United States, its departments, agencies or entities, its officers, employees. Fix or agents, or more.