## Facts

- Physicians Christopher J. Centeno and John R. Schultz, through Regenerative Sciences, LLC, offered the “Regenexx™ Procedure,” a non-surgical orthopedic treatment using a patient’s own mesenchymal stem cells.
- The procedure involved harvesting bone-marrow cells, processing and culturing/expanding them in a laboratory, and reinjecting the cultured cells into the patient in a solution containing additional substances.
- Regenerative and the affiliated clinic operated as a single business; Regenerative owned the procedure and exclusively licensed it to the clinic.
- At least one component used in administering the cultured-cell mixture (including an antibiotic such as doxycycline) had been shipped in interstate commerce.
- After inspecting defendants’ facility, the FDA concluded defendants caused a drug to become adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act (FDCA).
- The United States brought a civil enforcement action seeking declaratory relief and a permanent injunction; defendants argued the activity was intrastate medical practice and not federally regulable as a “drug.”

## Issues

1. Whether the cultured autologous stem-cell mixture used in the Regenexx™ Procedure is a “drug” under the FDCA and a “biological product” under the Public Health Service Act (PHSA).
2. Whether the FDCA’s interstate commerce requirement is met where the procedure occurs intrastate but uses components shipped in interstate commerce.
3. Whether the product was adulterated due to noncompliance with current good manufacturing practice (cGMP) requirements.
4. Whether the product was misbranded due to failure to satisfy prescription-drug labeling requirements or qualify for statutory/regulatory exemptions.
5. Whether FDA regulation of the product impermissibly regulates the state-controlled practice of medicine.

## Decision

- The court granted the United States’ motion for summary judgment.
- The court held the Regenexx™ mixture constituted a “drug” under the FDCA and a “biological product” under the PHSA.
- The court found the interstate commerce nexus satisfied because a drug component shipped in interstate commerce was used in administering the mixture.
- The court ruled the product was adulterated based on violations of cGMP requirements governing manufacturing methods, facilities, and controls.
- The court ruled the product was misbranded because labeling did not meet “adequate directions for use” requirements and did not contain the minimum information needed to qualify for exemptions.
- The court rejected defendants’ challenges to FDA authority and entered a permanent injunction barring continued use absent compliance with federal law.

## Legal Principles

- The FDCA definition of “drug” broadly includes articles intended to treat disease or intended to affect the structure or function of the body, including products derived from a patient’s own cells when prepared and administered as a treatment article.
- Culturing and expanding human cells beyond minimal manipulation may place a cellular product outside less stringent regulatory categories and subject it to drug/biologic regulation.
- Under FDCA § 331(k), acts that cause a drug held for sale after shipment in interstate commerce to become adulterated or misbranded fall within federal authority; use of any interstate-shipped component in the final administered product can satisfy the nexus.
- A drug is adulterated if manufacturing methods, facilities, or controls do not conform to cGMP; proof of actual patient harm is not required to establish adulteration.
- A prescription product is misbranded if its labeling lacks adequate directions for use and does not meet conditions for applicable exemptions.
- FDA regulation of manufacturing and labeling of a drug/biological product does not become unlawful regulation of medical practice merely because physicians administer the product within a clinical setting.

## Conclusion

The court concluded that defendants’ cultured autologous stem-cell mixture was a federally regulated drug and biological product, that use of interstate-shipped components supplied the statutory jurisdictional hook, and that undisputed manufacturing and labeling deficiencies rendered the product adulterated and misbranded, warranting summary judgment and a permanent injunction.


United States v. Regenerative Sciences, LLC, 878 F. Supp. 2d 248 (D.D.C. 2012)