Stephen Holland
Overview
Stephen Holland is a senior counsel in Crowell & Moring’s Government Affairs Group, where he leverages his extensive experience advising members of Congress and their staff as a policy advisor and attorney active in health care legislation. Stephen has been responsible for crafting dozens of provisions in law to improve food, drug, and medical device innovation and regulation at the Food and Drug Administration (FDA), health coverage and access, public health communication and coordination, prescription drug affordability, and emergency preparedness and response.
Career & Education
- United States House of Representatives
Senior Health Counsel, Committee on Energy and Commerce, 2021–2024
Health Counsel, Committee on Energy and Commerce, 2019–2021
Counsel, Office of Rep. Kurt Schrader (D-OR), 2013–2019
- United States House of Representatives
- Washington and Lee University School of Law, J.D., cum laude, 2013
- St. John's University, B.A., summa cum laude, 2010
- Virginia
- District of Columbia
Stephen's Insights
Client Alert | 3 min read | 06.26.25
FDA Targets Gene Editing Clinical Trials in China and other “Hostile Countries”
In a somewhat ambiguous press release on Wednesday, June 18, 2025, the Food and Drug Administration (FDA) announced a halt and “immediate review” of new clinical trials where American patients’ cells are sent to China or other “hostile countries” for genetic engineering with the expectation that the cells will be infused back into U.S. patients.[1] A subsequent podcast published by the agency also said that therapies that involved cells that were sent to China for genetic engineering and intended for subsequent infusion into U.S. patients would not be approved going forward. The announcement said that there is “mounting evidence” that some clinical researchers failed to obtain informed consent from trial participants about the international transfer and manipulation of biological material.
Webinar | 06.26.25 - 09.25.25
Press Coverage | 06.10.25
F.D.A. to Use A.I. in Drug Approvals to ‘Radically Increase Efficiency’
Client Alert | 3 min read | 06.04.25
CMS Issues Letters to Hospitals on Gender-Affirming Care Practices
Insights
F.D.A. to Use A.I. in Drug Approvals to ‘Radically Increase Efficiency’
|06.10.25
The New York Times (subscription required)
How SCOTUS' Decision In Chevron Could Change The Way The FDA Regulates Biopharma
|07.12.24
Endpoints News
MAHA’s Vision for Healthier Diets: Awaiting Concrete Steps and Assessing Challenges
|05.15.25
Crowell Health Solution’s Trends in Transformation
- |
01.31.25
Crowell Health Solution’s Trends in Transformation
House Task Force on AI Issues Report and Proposes Healthcare Recommendations
|01.31.25
Crowell Health Solution’s Trends in Transformation
- |
01.30.25
Crowell Health Solution’s Trends in Transformation
FDA Proposes Framework to Assess AI Model Output Credibility to Support Regulatory Decision-Making
|01.29.25
Crowell & Moring’s Health Law Blog
CMS Innovation Center Seeks Feedback on Medicare $2 Drug List Model
|10.30.24
Crowell Health Solution’s Trends in Transformation
FDA Publishes FAQs Around Its Recent Laboratory Developed Tests Final Rule
|08.12.24
Crowell Health Solution’s Trends in Transformation
FDA Issues Guidance on Using Electronic Health Records and Medical Claims Data in Clinical Studies
|08.01.24
Crowell Health Solution’s Trends in Transformation
Stephen's Insights
Client Alert | 3 min read | 06.26.25
FDA Targets Gene Editing Clinical Trials in China and other “Hostile Countries”
In a somewhat ambiguous press release on Wednesday, June 18, 2025, the Food and Drug Administration (FDA) announced a halt and “immediate review” of new clinical trials where American patients’ cells are sent to China or other “hostile countries” for genetic engineering with the expectation that the cells will be infused back into U.S. patients.[1] A subsequent podcast published by the agency also said that therapies that involved cells that were sent to China for genetic engineering and intended for subsequent infusion into U.S. patients would not be approved going forward. The announcement said that there is “mounting evidence” that some clinical researchers failed to obtain informed consent from trial participants about the international transfer and manipulation of biological material.
Webinar | 06.26.25 - 09.25.25
Press Coverage | 06.10.25
F.D.A. to Use A.I. in Drug Approvals to ‘Radically Increase Efficiency’
Client Alert | 3 min read | 06.04.25
CMS Issues Letters to Hospitals on Gender-Affirming Care Practices