FDA REGULATION OF 3D-PRINTED ORGANS AND ASSOCIATED ETHICAL CHALLENGES.

Author:Kelly, Elizabeth
Position:COMMENT
 
FREE EXCERPT

INTRODUCTION 516 I. WHAT IS 3D PRINTING AND WHO CARES? 518 A. The History and Mechanics of 3D Printing 518 B. The Market for 3D-Printed Organs 521 II. PAYING FOR 3D-PRINTED ORGANS IS "NOTA" FEDERAL CRIME 523 A. 3D-Printed Organs Are Not "Human Organs" 523 B. Market Rate Reimbursement Is Not "Valuable Consideration" 525 III. 3D-PRINTED ORGANS FIT IN THE EXISTING FRAMEWORK OF THE FEDERAL FOOD DRUG AND COSMETICS ACT AND CAN BE REGULATED BY 527 THE FDA A. The FDA Is the Appropriate Agency to Regulate 3D-Printed 527 Organs B. 3D-Printed Organs Will Be Regulated Differently than Human 528 Organs for Transplantation C. 3D-Printed Organs Should Be Regulated as Biological 529 Products D. 3D-Printed Organs Should Also Be Regulated as Drugs 530 E. 3D-Printed Organs Should Not Be Classified as Medical 531 Devices F. Bioprinted Organs Manufacturers Will Be Subject to Current 533 Good Manufacturing Practices and Current Good Tissue Practices IV. ETHICAL CONSIDERATIONS FOR TRANSPLANTING 3D-PRINTED ORGANS 537 A. There is No Applicable Constitutional Right to Access 537 Unapproved 3D-Printed Organs B. Perhaps Money Can Buy Organs 539 C. Will Insurers Ever Cover a Procedure to Keep Sick 541 Alive Longer? D. [Un]Informed Consent 541 E. 3D-Printed Organs Could Put Black Markets (For Organs) 542 Out of Business CONCLUSION 544 INTRODUCTION

"The liveliest--literally--field of 3D printing may sound like something from a sci-fi movie, but (spoilers) it's real and happening now." (1) Indeed, this new field is "nothing less than the start of a new industrial revolution," (2) and 3D printing promises to be a "disruptive" force in the market. (3) This spring, Boeing passed Federal Aviation Administration safety tests for the first printed structural components for a plane. (4) The plane manufacturer will start using 3D-printed parts in its engines, which will yield faster manufacturing processes and billions of dollars in savings. (5)

The potential applications of this new technology are endless. Industry leaders and world leaders alike recognize and are excited by this opportunity. As then-President Obama said, "3D printing has the potential to revolutionize the way we make almost everything." (6)

One of the applications that holds incredible promise is 3D printing in the medical context, which includes the possibility of 3D-printed organs for humans. (7) There will come a time in the not-so-distant future when our children or grandchildren will balk at the notion that, just a generation ago, people died because their doctors could not locate an organ--or only one with high risks of rejection--to complete the transplant. According to health care technology expert Tom Todorow, the introduction of 3D-printed organs into the medical landscape is a relative certainty; not a question of if, but when. (8) Root Analysis, a medical technology consulting company, anticipates that it should be possible to print kidneys in six years, with livers to follow soon after. (9) The prospect of printed organs necessitates the following question: is the market ready for 3D-printed organs? The answer, with some reservations about the ethical challenges ahead, is yes: the regulatory regime as it currently stands can handle 3D-printed organs.

Before delving into the questions surrounding 3D printing in the medical field specifically, the U.S. organ shortage crisis warrants attention. On average, twenty-two people die every day while awaiting an organ transplant. (10) The waitlist for organs is over 116,000 people long and, every 10 minutes, someone new is added. (11) Over the last 5 years, the number of organ transplants has increased by 20 percent, hitting a new record of over 33,500 transplants in 2016. (12) The organ supply will not catch up with the current demand without some assistance from another source--such as printers that can manufacture organs.

The implications of pervasive implementation of 3D printing with biological material, also known as "bioprinting," are vast. They present never-before-seen hurdles, which are particularly complicated due to the vulnerability of the patients, who often need new organs to survive, involved. In this Comment, I limit the scope of this inquiry to the most immediate challenges of embracing 3D-printed organs in our health care market: potential statutory roadblocks, regulatory concerns over manufactured organs, and ethical challenges of which we must remain aware. I submit one path by which 3D-printed organs can fit in our current legal and regulatory framework. I also define who should be charged with regulating them and propose how future regulators should do so. Finally, I raise additional concerns of 3D-printed organs that will require deeper analysis as more information becomes available, including the myriad ethical challenges presented by this new technology.

The U.S. Food and Drug Administration (FDA) is the appropriate body to regulate 3D-printed organs because a manufactured organ must be treated differently than a human organ, which can be transplanted as "simply" part of the practice of medicine. It remains to be seen how the FDA will gather sufficient data to satisfy premarket approval requirements, determine who gets access and when, and how to govern the marketing of 3D-printed organs because the output is individualized. But the process by which the organs are created can be scaled dramatically. In so doing, those in charge must also confront unique, multifaceted ethical challenges.

  1. WHAT IS 3D PRINTING AND WHO CARES?

    1. The History and Mechanics of 3D Printing

      The concept of 3D printing has existed for decades, but industries, scientists, and engineers only recently started to appreciate its full potential. Chuck Hull, an American inventor with a background in engineering and physics, created the concept of 3D printing back in the 1980s, yet he was only just formally recognized for this accomplishment. (13)

      Three-dimensional outputs from a 3D printer are created, in some ways, by similar means as a conventional two-dimensional printer. Instead of the two-dimensional layer of ink traditionally seen on a printed page, the 3D printer puts billions of layers of whatever material composes the "ink" on top of one another to create the object. (14) Together, they form the output that the printer was instructed to create.

      3D printing is also sometimes called "additive manufacturing," in reference to the "additive" process by which the printer creates its three-dimensional output. Rather than moving across a piece of paper to place a single layer of ink dots, the 3D printer goes back and forth many more times, "laying down successive layers of materials" from computer-aided design (CAD) files that the physicians and engineers worked together to create. (15) These printers do not use conventional printer ink, but rely on a variety of materials, "including] plastics, polymers, glass, metal, wax, edible goods and even human tissue." (16)

      In the early 2000s, scientists "discovered that living cells could be sprayed through the nozzles of inkjet printers without damaging them." (17) Hull himself was surprised at how quickly it became apparent that this technology could, and was going to, revolutionize the medical field. (18)

      When bioprinting an organ, a patient's own cells are used, rather than using synthetic materials. A commonly used method begins with a biopsy to remove some of a patient's cells. The biopsied cells are subsequently subjected to a "growth medium to proliferate cell growth and multiplication and to form aggregate cells that are the base of 'bioink.'" (19) The "bioink" is then layered in the same way as described above. Sometimes an additive must be used to ensure that the bioink is printed in the right shape. This additive can be removed once the printing process is complete, at which point the "as-formed bioprinted tissue is left to grow" (20) or it can be made of biocompatible material (21) or can be biodegradable. (22) Currently, researchers are working to determine how to print complicated and intricate bodies of blood vessels that will produce the necessary supply of blood and oxygen through a printed organ and to the rest of a patient's body. (23) This is a significant barrier to market entry, but technological advances continue to provide hope. (24)

      While the application of bioprinting remains in its relatively nascent stages, (25) the medical field currently utilizes other, less biologically-based applications in hospitals and for training purposes.

      Challenges of advancing 3D printing with biomaterials need not detract from the remarkable success 3D printing has already achieved in health care. Some 3D-printed products currently in use in the medical field include dental implants, tailored orthopedics and tools used in maxillofacial surgery. (26) To be clear, the arguments I submit herein refer to the novel use of 3D printers to create biologically-based, synthetic organs. The manufacturing process itself is regulated separately and it is not covered in this Comment. By printing an exact replica of a specific human's organ with synthetic materials, doctors can practice before performing operations on their patients. (27) This opportunity benefits new medical students and the most experienced surgeons alike.

      Furthermore, some companies have successfully printed organic tissues, (28) which can be used for drug and cosmetic testing. (29) The FDA has also approved drugs (30) and devices (31) created with the help of 3D printing. While most drugs are not yet patient or sub-population specific on a large scale, the technology has allowed for the creation of "devices unique to... specific patient[s]." (32) A recent example of this is FDA approval of Kymriah, a groundbreaking drug that "uses patients' genetically altered immune cells to fight" leukemia in children and young adults. (33)

      Among those who understand the promise of 3D printing, it is rare to find someone capable...

To continue reading

FREE SIGN UP