D.C. Circuit Court of Appeals Upholds FDA Oversight of Autologous Stem Cell Therapeutics

by Saul Ewing Arnstein & Lehr LLP


A company that developed a stem cell-based therapy for treating diseases and conditions was found to be in violation of the federal Food, Drug, and Cosmetic Act for failing to seek approval for its product. Cellular and tissue-based therapeutics derived from processes that alter the biological characteristics of cells or tissue, and such products that include an ingredient shipped interstate, are subject to FDA regulation.

The United States Court of Appeals for the District of Columbia Circuit recently affirmed a ruling that a cellular mixture consisting of a patient’s own stem cells and the antibiotic doxycycline is subject to regulation by the U.S. Food and Drug Administration (the “FDA”). In United States v. Regenerative Sciences, LLC, No. 12-5254, slip op., — F.3d — (D.C. Cir. Feb. 4, 2014), the appellants (referred to collectively as “Regenerative”) developed and marketed an autologous stem cell-based therapy for treating orthopedic conditions and diseases. The therapy consisted of extracting mesenchymal stem cells from a patient’s bone marrow and culturing the cells for proliferation and development of certain biological characteristics. Doxycycline was also added to prevent bacterial contamination. Then, the cellular mixture was injected back into the patient. The FDA brought an enforcement action against Regenerative, arguing that Regenerative never sought FDA approval of its mixture and, as such, its product violated the Food, Drug, and Cosmetic Act (the “FDCA”) and the Public Health Service Act (the “PHSA”). The district court granted summary judgment in favor of the government and entered a permanent injunction against Regenerative.

On appeal, Regenerative claimed that its stem cell mixture was not subject to FDA regulation because it was, in fact, a medical procedure. The court disagreed and reached the following key conclusions regarding the cell mixture:

  • The court agreed with the FDA that the mixture was a combination of drug and biological product under the FDCA and PHSA and, therefore, was subject to FDA scrutiny. Regenerative should have obtained the necessary approvals. As a result, the product was adulterated and misbranded.
  • The court agreed with the FDA that Regenerative’s product did not satisfy the “minimal manipulation” requirement for exemption under 21 C.F.R. § 1271.10, which provides that the product is not regulated as a drug or biologic under the FDA regulations, because the mixture altered the biological characteristics of the resultant cell population through its culturing process.
  • The court disagreed with Regenerative and explained that the FDA was not attempting to regulate the practice of medicine. Rather, it was regulating the distribution of a drug. Furthermore, the Commerce Clause did not pose an obstacle because the product affected interstate markets for orthopedic care and used an ingredient (doxycycline) that is shipped interstate. By focusing on the inclusion of this ingredient, the court extended to stem cell therapy a principle that had previously been applied only to prescription drugs. The mere introduction of an ingredient that is transported interstate satisfies the “shipment in interstate commerce” requirement of 21 U.S.C. § 331(k), to bring the entire stem cell mixture within the ambit of FDA regulation.

Clinics and biological companies working in the stem cell space should take note of two key takeaways from the D.C. Circuit decision. First, “minimal manipulation” under 21 C.F.R. § 1271.10 is interpreted to exclude any processing that changes the biological characteristics of the resultant cell population. The Regenerative decision leaves open whether just one of these steps — culturing or the addition of doxycycline — would have exceeded minimal manipulation. In the absence of clearer guidance from the court, companies and clinics should carefully examine their processes to determine whether any one step might exceed minimal manipulation, requiring the product to comply with the FDA regulatory process, including product approval.

Second, a product that includes just one ingredient that is shipped interstate is deemed sufficient to satisfy the Commerce Clause and “interstate commerce” requirement under 21 U.S.C. § 331(k). The D.C. Circuit made it clear that shipment of the entire product interstate is not necessary. Therefore, as with prescription drugs, if a cellular or tissue-based product merely includes an ingredient that is shipped interstate, the manufacturing company may be in violation of the FDCA and PHSA if it has not obtained the necessary regulatory approvals.

To download a copy of the D.C. Circuit decision, please click here.

Saul Ewing attorneys can assist companies in the life sciences industry with addressing these and other regulatory compliance issues.

View Document(s):

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Saul Ewing Arnstein & Lehr LLP | Attorney Advertising

Written by:

Saul Ewing Arnstein & Lehr LLP

Saul Ewing Arnstein & Lehr LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.


JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at info@jdsupra.com. In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at: info@jdsupra.com.

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.