Approximately 100,000 Americans are waiting an organ transplant. The vast majority will are awaiting a a kidney - that, on average, will take five years. Approximately 20 Americans die every day awaiting an organ. These and related statistics rank the US well below other developed countries. For example, only 30% of US kidney failure patients have a functioning transplant and only 3% have received a preemptive transplant. For these reasons CMS recently announced three kidney disease demonstrations: the ESRD Treatment Choices demonstration that began this past January 1st; and, the Kidney Care First and the Comprehensive Kidney Care Contracting demonstrations scheduled to start this coming January 1st. These efforts aside, the the optimal solution appears to be 3D bioprinting as an avenue for generating artificial organs. The first demonstration of such occurred in 1999 when Wake Forest’s Institute for Regenerative Medicine’s implanted an bioprinted human bladder into a patient. (This interview was conducted on September 3rd.)
During this 32 minute conversation Mr. Troy begins by providing additional details concerning the state of organ transplantation in the US and internationally and meeting the demand going forward with increasing chronic disease and potential long term COVID health effects. Mr. Troy provides an overview of how 3D bioprinting, discusses why FDA regulation is required, e.g., such that bioprinting has pathway to market and how bioprinting is regulated by the FDA, e.g., as a device and/or a biologic. He too comments on the potential conflict of selling bioprinted organs in context of limitations under the National Organ Transplant Act of 1984, concerns regarding social stratification or who gets 3D printed organs, and the life, theoretical at least, of bioprinted human organs and to the extent bioprinted organs can be protected as intellectual property.
Mr. Dan Troy currently serves as Chief Legal Officer & General Counsel for Valo, the Boston-based drug development company. Previously, Mr. Troy served as the General Counsel of
GlaxoSmithKline from 2008 until 2018. Before that, Mr. Troy was a partner in the FDA practice at Sidley Austin which he joined after serving as FDA Chief Counsel. Previously still, he practiced constitutional, administrative, and appellate law at Wiley Rein and Fielding, served in the Office of Legal Counsel at the US Department of Justice, and clerked for DC Circuit Judge Robert H. Bork. Mr. Troy earned his JD at Columbia Law School, where he was a Kent and Stone Scholar, and a BS from the Cornell University School of Industrial and Labor Relations. He is the author of numerous publications and currently chairs the US Litigation Center. In 2013, the Burton Awards named him a “Legend in the Law.”
Mr. Troy's related June STAT essay, "3D Bioprinting Can Help End Organ Transplant Waitlists - if the FDA Stops Delaying," is at: https://www.statnews.com/2021/06/18/3d-bioprinting-organ-transplant-waitlists-fda-delay/.
245th Interview: Dan Troy Discusses 3D Bioprinting Human Organs and the FDA's Regulation Thereof (September 7th)