By: Cullen Irwin
With the advent of a new administration and the overturning of Chevron comes deregulation initiatives across several industries, creating a slew of implications for drug regulation under the watch of the newly minted Secretary of the Department of Health and Human Services, Robert Kennedy, Jr. (RFK Jr.). RFK Jr.’s confirmation resulted in significant controversy surrounding his views on the pharmaceutical drug industry. At the forefront of this controversy are his opinions on vaccines and America’s “chronic disease epidemic.”[1] However, his agenda to advance stem cell therapies over the next four years of the Trump Administration’s governance has somewhat flown under the radar. The possible deregulation of the stem cell industry could have extensive effects on the pharmaceutical market and North Carolina’s research triangle.
Stem Cell Therapy and The FDA’s Regulatory Structure
Regenerative medicine rooted in stem cell engineering has become increasingly prominent in the medical zeitgeist, especially since a 2006 study authored by Shinya Yamanaka and Kazutoshi Takahashi discovered that it was “possible to reprogram multipotent adult stem cells to their pluripotent state.”[2] Pluripotent stem cells can differentiate into any cell type within the body, making their medical treatment applications comprehensive and ground-breaking.[3]These medical applications range from treating skeletal muscle injuries[4] and brain tumors[5] to providing organ transplants[6] and skin replacement surgeries.[7] Nevertheless, developing regenerative medicines has its perils and warrants regulation to combat dangerous products reaching the market and patients’ bodies.
As a result and pursuant to its authority to regulate regenerative medicinal therapies under the Public Health Service Act (PHSA),[8] the FDA has issued a regulatory structure under 21 C.F.R. § 1271 to regulate “[h]uman cells, tissues, or cellular or tissue-based products (HCT/Ps)[,] mean[ing] articles containing or consisting of humans cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.”[9] Due to the broad nature of HCT/Ps, the FDA regulates the products in a “tiered, risk-based” format, where certain HCT/Ps receive higher regulatory scrutiny.[10]
HCT/Ps are classified as “drugs” by default and are, therefore, subject to the entirety of the FDA’s regulatory scheme, including 21 C.F.R. § 1271.[11] However, an HCT/P is exempted from the FDA’s extensive premarket approval process and only subject to Section 361 of the PHSA if the HCT/P meets four criteria outlined in Section 1271.10.[12] Furthermore, an HCT/P is completely exempted from Section 1271 if it meets any one of the five exceptions in Section 1271.15. For example, if the HCT/P in question is removed “from an individual and implant[ed] … into the same individual during the same surgical procedure,” then it is exempted from Section 1271.[13] Needless to say, satisfying any of the exceptions “means that a company can bring its product to market for a fraction of the resources it would have had to spend if its HCT/P were regulated as a new drug.”[14] As a result, litigation has arisen to determine the proper interpretation of the “same surgical procedure” (SSP) exception.
The Eleventh and Ninth Circuits have both narrowly interpreted the SSP exception, holding that the stem cell therapy procedure which consists of removing fat tissue, chemically isolating stromal vascular fraction (SVF) and reinjecting the SVF into the patient during the same procedure does not meet the SSP exception.[15] For example, the Ninth Circuit deferred to the FDA’s interpretation of the SSP exception, which “implies that a surgical procedure cannot qualify for the SSP exception if it involves more than minimal manipulation of HCT/Ps.”[16] In comparing the HCT/P removed to the HCT/P reinjected during the procedure, the Circuit determined that the relevant HCT/P removed was the fat tissue as a whole, not the cells within the tissue. Upon removal, the fat tissue is chemically reduced to SVF, but the structure of the initial fat cells and the cells in the final SVF product are the same and, therefore, minimally manipulated. However, the court’s comparison of the fat tissue itself as the relevant HCT/P comparator rendered the reinjected HCT/P manipulated.[17] Courts have yet to speak on whether this interpretation of the SSP exception would apply in different therapies or whether the interpretation changes under the non-deferential standard of Loper Bright. Nevertheless, the use of stem cell therapies is bound to be subject to increasing litigation over the next decade, and the current administration’s views on stem cell treatments may alter this course of litigation.
The New Administration’s Position on Stem Cells and Future Implications
In October 2024, RFK Jr. publicly criticized the FDA’s “war on public health” through its “aggressive suppression of… stem cells.”[18] He later stated in his senate confirmation hearing that he “will protect stem cell research.”[19] These sentiments align with President Trump’s Right to Try Act, which he championed in his first term. The Right to Try Act promoted citizens’ ability to try unapproved treatments to combat life-threatening conditions.[20]Thus, it follows that President Trump likely supports RFK Jr.’s policy of loosening regulations surrounding stem cell research and therapeutical use in order to increase the treatment options available to the American public.
Trump’s recent executive order requiring federal agencies to eliminate 10 existing regulatory documents for every new regulatory action could be leveraged by RFK Jr. to justify the deregulation of the stem cell industry, and, at a minimum, could decrease the requirements for meeting a regulatory exception under the PHSA or 21 C.F.R. § 1271. Such deregulation could spark increased clinical use of stem cell therapy and has the potential to create hundreds of thousands of jobs across the country.
In 2004, California passed a $3 billion bond to fund the California Institute for Regenerative Medicine.[21]“The direct and indirect economic benefits of the funding” led to approximately 56,000 jobs and $10 billion for California’s economy.[22] Deregulation in this field may lead to significant government and private funding efforts in states like North Carolina, which operate as a hub of stem cell research.[23] Wake Forest University, for example, is a leading institution in biosynthetic organ engineering and related stem cell research. Even though biosynthetic organs are considered “tissue-based products” and are thereby classified as “high-risk” and always subject to premarket review, increased funding for institutions like Wake Forest is bound to create more jobs and produce more money for thriving biotech economies such as North Carolina.[24]
Despite the ethical issues concerning stem cell research and treatment, breakthroughs suggest that many ethical problems may be circumvented.[25] Nevertheless, the tides seem to be shifting towards American innovation in the stem cell arena, hopefully leading to fewer Americans venturing outside the U.S. for these treatments.[26] Ultimately, the balance between safety regulations and the call for further stem cell research will determine the pace at which this field advances. With the new administration in place, the scales will likely tip in favor of the stem cell industry.
[1] Hearing to Consider Robert F. Kennedy Jr. to be Secretary of the Department of Health and Human Services Before the Comm. on Finance, 119th Cong. (2025) [hereinafter RFK Jr. Hearing] (statement of Robert F. Kennedy Jr.).
[2] Wojciech Zarkrzewski et al., Stem Cells: past, present, and future, Stem Cell Rsch. & Therapy (Feb. 26, 2019), https://stemcellres.biomedcentral.com/articles/10.1186/s13287-019-1165-5.
[3] Antonio Romito & Gilda Cobellis, Pluripotent Stem Cells: Current Understanding and Future Directions, Stem Cells Int’l (Dec. 20, 2015), https://pmc.ncbi.nlm.nih.gov/articles/PMC4699068/.
[4] See Andres J. Quintero et al., Stem Cells for the Treatment of Skeletal Muscle Injury, 28 Clinics in Sports Med. 1 (2009).
[5] Thania Benios, These Human Stem Cells Could Change the Way We Fight Cancer, World Econ. F.: Health and Healthcare Sys. (Feb. 13, 2017), https://www.weforum.org/stories/2017/02/these-human-stem-cells-could-change-the-way-we-fight-cancer/.
[6] ABCs of Organ Engineering, Wake Forest Univ. Sch. of Med.: Wake Forest Inst. for Regenerative Med. (WFIRM) (last visited Apr. 12, 2025), https://school.wakehealth.edu/research/institutes-and-centers/wake-forest-institute-for-regenerative-medicine/research/abcs-of-organ-engineering#Learn%20About%20the%20Steps%20Involved%20in%20Engineering%20Tissue%20and%20Organs.
[7] Ming Chen et al., Stem Cells for Skin Tissue Engineering and Wound Healing, 37 Critical Revs. in Biomed. Eng’g 399 (2010).
[8] 42 U.S.C.A. § 262 (West).
[9] 21 C.F.R. § 1271.3(d).
[10] Dominick DiSabatino & Audrey Mercer, What to Expect for stem Cell Regulation Under Trump Admin, Law360 (Mar. 25, 2025), https://plus.lexis.com/newsstand/law360/article/2315058?location=%27Expert+Analysis&crid=77b25b40-c7c8-4a01-8858-964ba8c84cc5.
[11] Id.
[12] 21 C.F.R. § 1271.10.
[13] 21 C.F.R. § 1271.15(b).
[14] DiSabatino & Mercer, supra note 10.
[15] United States v. US Stem Cell Clinic, LLC, 998 F.3d 1302 (11th Cir. 2021); United States v. California Stem Cell Treatment Ctr., Inc., 117 F.4th 1213 (9th Cir. 2024).
[16] California Stem Cell Treatment Ctr., Inc., 117 F.4th at 1225.
[17] Id. at 1225–26.
[18] Robert F. Kennedy Jr., X (Oct. 25, 2024, 5:25 PM), https://x.com/RobertKennedyJr/status/1849925311586238737?lang=en.
[19] RFK Jr. Hearing, supra note 1.
[20] DiSabatino & Mercer, supra note 10.
[21] Dana Goldman et al., The Economic Case for Public Investment in Stem Cell Research, USC Schaeffer Inst. for Pub. Pol’y & Gov’t Serv.(June 24, 2020), https://schaeffer.usc.edu/research/the-economic-case-for-public-investment-in-stem-cell-research/.
[22] Id.
[23] North Carolina: A Thriving Gene and Cell Therapy Hub, N.C. Biotech. Ctr.: Gene and Cell Therapy (last visited Apr. 25, 2025), https://www.ncbiotech.org/transforming-life-sciences/sectors-attention/gene-and-cell-therapy.
[24] Caroline Veronique Oberweis et al., A Worldwide Overview of Regulatory Frameworks for Tissue-Based Products, 26 Tissue Eng’g Part B 181, 187 (2020).
[25] See generally Bernard Lo & Lindsay Parham, Ethical Issues in Stem Cell Research, 30 Endocrine Revs. 204 (2009).
[26] Verónica Gaez, Americans Travel Overseas for Stem Cell Treatment, Stem Cell Inst. (last visited Apr. 12, 2025), https://www.cellmedicine.com/news283/#:~:text=Since%20stem%20cell%20treatment%20cannot,%E2%80%9CIt’s%20a%20slow%20progress.
