FDA Stem Cell

A big update in the stem cell industry last week as a California judge issued a favorable order on behalf of a California based stem cell treatment provider. California Stem Cell Treatment Center, Inc., is a California based medical company offering SVF surgical procedure and MSC Surgical procedures. A few years ago, the Food and Drug Administration (“FDA”) sought an injunction against the Company to prevent them from performing these procedures because the FDA claimed that the procedures included the adulteration of drugs which were then re-injected into the patient and thus were classified as “drugs” and therefore under the FDA purview. The Company argued, however, that the SVF procedure and MSC procedure are not “drugs” as defined by the FDA and there that the procedures don’t fall under the FDA’s definition/prohibition regarding adulteration and misbranding of products. The Court allowed the trial to move forward, and the Company provided support of their position which ultimately was successful. The Judge agreed that the procedures and the subsequent cells were not “drugs” and went on to further state that the SVF procedure qualifies for the “Same Surgical Exception” under the Food Drug and cosmetics Act (“FDCA”) even so.

The ruling in this case reinforces the Florida based company, US Stem Cell, position and is contrary to the ruling made in its case back in 2019. The Court also made it clear that the FDA does not have the ability to interfere with the practice of medicine of physicians, as limited by Congress and the FDCA. The Court, through its ruling, removed some of the power of the FDA in these types of cases, essentially saying that they do not have oversight on surgical procedures (which the Court believes these procedures constitute).

So, what does this mean? It certainly pushed back on the FDA and its reach big time. It means the FDA will either take a step back from stem cell regulation and allow these clinics to operate with less scrutiny, or it means the FDA will work with Congress to update their governing statutes and expand their purview. For the time being, it keeps the FDA at bay.

What’s New with Regenerative Medicine?

The field of regenerative medicine is ever expanding and evolving. As more viable options become available to patients, it’s important to stay abreast of regulation surrounding many of these applications.

In late 2019, the Food and Drug Administration (FDA) began informing the public of multiple reports of serious adverse events experienced by patients who were “treated” with non-FDA approved products marketed as containing exosomes. As a general matter, exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products under the Public Health Service Act and the Federal Food Drug and Cosmetic Act and are subject to premarket review and approval requirements. At the time of the 2019 warning, there were no FDA-approved exosome products and the FDA since then has not put out any new guidance.Continue reading

Stem Cell Litigation Update: FDA Granted an Injunction

stem cell litigationBy: Matt Fischer

In a decision expected to cause waves through the rapidly-expanding regenerative medicine industry, a U.S. District Court Judge ruled on June 3rd that the U.S. Food and Drug Administration (FDA) is entitled to an injunction in a lawsuit filed against U.S. Stem Cell Clinic, LLC (US Stem Cell) based in Sunrise, Florida.  In her decision, U.S. District Court Judge Ursula Ungaro agreed that the FDA has the authority to regulate the popular stem cell procedure known as stromal vascular fraction (SVF) – administering processed stem cells derived from adipose tissue (i.e. fat tissue) – and that US Stem Cell is not exempt from regulation.

To recap, in May 2018, the U.S. Department of Justice (DOJ) filed complaints against US Stem Cell and a California stem cell clinic seeking permanent injunctions to prevent the marketing and administration of the SVF procedures without FDA approval.  Prior to the filing of these actions, both companies received warning letters from the FDA.  The letters also addressed the results of inspections and the need to resolve significant deviations from manufacturing practice requirements. Continue reading

Second Proposed Stem Cell Bill Goes to Florida House of Representatives

stem cell billBy: Matt Fischer

On November 29, 2018, Florida Representative Chuck Clemons proposed house bill 65 (“HB 65”) that would significantly tighten regulation on the use of stem cells.  If the stem cell bill is signed into law, Florida will join other states (e.g. California, Texas and Washington) in passing some type of stem cell regulation.  While some bills around the country have centered the regulation on informing prospective customers of the risks associated with these treatments, HB 65 takes a more stringent approach with the threat of criminal exposure and includes certain protections for providers in the form of a “right-to-try” law.

Some of the highlights of HB 65 include:Continue reading

I Want to Start a Stem Cell Distribution Business…Now What?

By: Matthew Fischer

Jumping into the stem cell industry can be an exciting venture.  However, with this emerging industry comes a mine field of legal pitfalls and potential problems.  The keys to a successful business not only include selecting a strong product and building strong relationships with clients but being able to navigate the regulatory framework that accompanies this type of product.

FDA regulations require establishments that perform one or more steps in the manufacturing process of HCT/Ps (i.e. Human Cells, Tissues, and Cellular and Tissue-Based Products) to register and submit a list of products with the agency.  If so, you have five days to register after beginning operations.  When I mention “manufacturing” to clients they usually interject with “I only want to distribute.”  Good point.  However, the FDA defines “manufacture” as any or all steps in the recovery, processing, storage, labeling, packaging, or distribution of any human cell or tissue.  These registrations must be updated annually and in the event of a change of ownership, within 30 days of the change. Continue reading

FDA Stem Cell Clinic Legal Issues: Stepped Up Enforcement

healthcare regulatory compliance audit

By: Matthew Fischer

With the rapid growth of the regenerative medicine field, the U.S. Food and Drug Administration (FDA) is trying to strike the right balance between preventing harm to the public and fostering innovation of new treatments.  In an effort to prevent potential harm, the FDA stepped up enforcement this week.  In two complaints filed by the U.S. Department of Justice (DOJ) on behalf of the FDA, the FDA has sought permanent injunctions against a California and Florida stem cell clinic along with their owners and officers to prevent the marketing of stem cell products without FDA approval and for failure to correct deviations from manufacturing practice requirements.Continue reading

New State Stem Cell Laws: A Brief Overview

stem cell law

By: Matthew Fischer

Amid the growing focus on stem cell products by the Federal Food and Drug Administration (FDA), multiple states have proposed and passed some form of stem cell law or clinic regulation.  While some center the regulation on informing prospective customers of the risks associated with these treatments others seek to protect the availability of these treatments in the form of a “right-to-try” law.  Here are a few examples:

California

Effective January of this year, California implemented a new regulation in its Business and Professions Code aimed at clinics offering non-FDA approved stem cell treatments.  The regulation requires a notice to be posted at the clinic entrance along with the requirement to provide a separate written notice to the patient prior to initiating treatment.  However, this requirement does not apply if a licensed health care practitioner has obtained approval for an investigational new drug from the FDA. Continue reading

Stem Cell Legal Update: Senator Targets Unproven Procedures

stem cell legal

stem cell legalBy: Matthew Fischer

Iowa Senator Chuck Grassley issued a press release last week indicating that he sent a letter to the leadership of the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) seeking additional information regarding the investigation into U.S. Stem Cell Clinic, LLC based in Sunrise, Florida.  The letter poses seven questions with a deadline of April 27th.  Last November, the FDA issued new guidance regarding human cell and tissue based treatments and announced its intention to crackdown on unproven treatments.  Hence, many in the industry are watching closely to see what actions if any have been taken.

In August 2017, the FDA issued a press release setting forth the details of a warning letter sent to U.S. Stem Cell Clinic, LLC.  The warning letter cited manufacturing deviations, efforts to impede an investigation, and issuance of a demand for corrective action.  This step was taken as a result of several people experiencing blindness after receiving stem cell injections for treatment of macular degeneration.  One of the patients noted that she believed the treatment was part of a clinical trial listed on ClinicalTrials.gov.Continue reading

The Regenerative Medicine Fast Track: What is the RMAT Designation?

RMAT designationBy: Matthew Fischer

The regenerative medicine arena consists of a wide range of innovative products.  Congress, acknowledging the importance of this field, has established a new program via the 21st Century Cures Act to help spur development and provide for accelerated approval for regenerative medicine products similar to the FDA’s fast track and breakthrough therapy designations.  This new approval is the Regenerative Medicine Advanced Therapy (RMAT) Designation.

The RMAT Designation includes all the benefits of the FDA’s other accelerated designations including early agency engagement and priority review; however, unlike the other designations, the RMAT Designation does not require evidence that the product offers substantial improvement over other therapies.  For a drug to be eligible for the RMAT Designation, it must meet the following:Continue reading

Balancing Safety and Innovation: Key Takeaways From The FDA’s Latest Stem Cell Reports

fda stem cell businessBy: Matthew Fischer

Through two public channels this month, the FDA further solidified its stance on the innovative field of regenerative medicine.  First, in an article published in the New England Journal of Medicine (NEJM), Dr. Scott Gottlieb, FDA Commissioner, and Dr. Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research (CBER), co-wrote a new paper entitled “Balancing Safety and Innovation for Cell-Based Regenerative Medicine.”  On the same day of this publication, the FDA hosted a “Grand Rounds” webcast with Dr. Steven Bauer, Chief of the Cellular and Tissues Therapy Branch within CBER.  Taken together, these actions suggest a continued effort by the FDA to take a strong position against predatory clinics touting unapproved therapies while extending an open invitation to industry developers for expedited treatment to encourage innovation.Continue reading