Increasing Drug Importation To Lower Prices for American Patients

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Published

July 29, 2020

Signed

July 24, 2020

Issuing agencies

Executive Office of the President

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<title>Federal Register, Volume 85 Issue 146 (Wednesday, July 29, 2020)</title>
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[Federal Register Volume 85, Number 146 (Wednesday, July 29, 2020)]
[Presidential Documents]
[Pages 45757-45758]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2020-16624]




                        Presidential Documents 



Federal Register / Vol. 85, No. 146 / Wednesday, July 29, 2020 / 
Presidential Documents

[[Page 45757]]


                Executive Order 13938 of July 24, 2020

                
Increasing Drug Importation To Lower Prices for 
                American Patients

                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. Purpose. Americans spend more per capita on 
                pharmaceutical drugs than residents of any other 
                developed country. Americans often pay more for the 
                exact same drugs, even when they are produced and 
                shipped from the exact same facilities.

                One way to minimize international disparities in price 
                is to increase the trade of prescription drugs between 
                nations with lower prices and those with persistently 
                higher ones. Over time, reducing trade barriers and 
                increasing the exchange of drugs will likely result in 
                lower prices for the country that is paying more for 
                drugs. For example, in the European Union, a market 
                characterized by price controls and significant 
                barriers to entry, the parallel trade of drugs has 
                existed for decades and has been estimated to reduce 
                the price of certain drugs by up to 20 percent. 
                Accordingly, my Administration supports the goal of 
                safe importation of prescription drugs.

                Sec. 2. Permitting the Importation of Safe Prescription 
                Drugs from Other Countries. The Secretary of Health and 
                Human Services shall, as appropriate and consistent 
                with applicable law, take action to expand safe access 
                to lower-cost imported prescription drugs by:

                    (a) facilitating grants to individuals of waivers 
                of the prohibition of importation of prescription 
                drugs, provided such importation poses no additional 
                risk to public safety and results in lower costs to 
                American patients, pursuant to section 804(j)(2) of the 
                Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 
                384(j)(2);
                    (b) authorizing the re-importation of insulin 
                products upon a finding by the Secretary that it is 
                required for emergency medical care pursuant to section 
                801(d) of the FDCA, 21 U.S.C. 381(d); and
                    (c) completing the rulemaking process regarding the 
                proposed rule to implement section 804(b) through (h) 
                of the FDCA, 21 U.S.C. 384(b) through (h), to allow 
                importation of certain prescription drugs from Canada.

                Sec. 3. 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 the Office of Management and Budget 
relating to budgetary, administrative, or legislative proposals.

                    (b) This order shall be implemented consistent with 
                applicable law and subject to the availability of 
                appropriations.

[[Page 45758]]

                    (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.
                <GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT>
                
                    (Presidential Sig.)

                THE WHITE HOUSE,

                    July 24, 2020.

[FR Doc. 2020-16624
Filed 7-28-20; 2:00 pm]
Billing code 3295-F0-P


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