Introduction

On July 10, 2019, President Trump issued an Executive Order on Advancing American Kidney Health (the EO). Executive orders are issued under the authority of the Constitution, Article II, Sections 1 and 3, requiring that the President "shall take care that the laws be faithfully executed." During his first 100 days in office, President Trump issued more executive orders than any other president.

The EO recites in part that the "state of care for patients with chronic kidney disease and end-stage renal disease (ESRD) is unacceptable" . . . that "too many at-risk patients progress to late-stage kidney failure" … and "there are not enough kidneys donated to meet the current demand for transplants."

The EO also provides specifics, including that kidney disease was the ninth-leading cause of death in the United States in 2017" … that "approximately 37 million Americans have chronic kidney disease and more than 726,000 have" … end-stage renal disease (ESRD), and that "nearly 100,000 Americans are on the waiting list to receive a kidney transplant."

Policy

The EO contains three overarching policies:

(a) prevent kidney failure whenever possible through better diagnosis … and treatment …;

(b) increase patient choice through affordable alternative treatments for ESRD by … encouraging the development of artificial kidneys; and

(c) increase access to kidney transplants by modernizing the organ recovery and transplantation systems and updating outmoded and counterproductive regulations.

Actions

Sections 3-8 direct the secretary of the Department of Health and Human Services (the department) to take certain actions in furtherance of the above policy statements. Included among these and of particular importance is section 6, aimed at encouraging the development of an artificial kidney.

Section 6 recites in part:

Within 120 days of the date of this order … the secretary shall:

(a) announce that the department will consider requests for premarket approval of wearable or implantable artificial kidneys in order to encourage their development and to enhance cooperation between developers and the Food and Drug Administration (FDA); and

(b) produce a strategy for encouraging innovation in new therapies through the Kidney Innovation Accelerator (KidneyX), a public-private partnership between the department and the American Society of Nephrology.

The development of artificial organs such as artificial kidneys can be achieved through multiple approaches. One approach entails using medical devices, often in conjunction with a therapeutically active molecule or biologic, to augment or replace an organ. An example of this approach is the FDA's approval of an "artificial pancreas."

Another approach (within the field of regenerative medicine) is to make implantable organs that contain blood vessels and the appropriate structure and cell types to replace or augment a failing organ. An example of a company taking this approach is Miromatrix and its mirokidney, which recently won a KidneyX Award.

Conclusion

The EO and its actions should encourage, among other things, the development of novel kidney disease diagnostics that achieve at least one of the following functions: predictive, diagnostic, disease state monitoring; and the further development artificial kidneys. Companies developing diagnostics and artificial kidneys are encouraged to understand the EO and to take advantage of its beneficial provisions.

Charles Andres contributed to the preparation of this WSGR Alert.