United States Department of Justice vs AniCell Biotech LLC
You might have seen or heard that the United States Department of Justice, on behalf of the U.S. Food and Drug Administration (“FDA” or “the Agency”), has recently filed a complaint against AniCell Biotech LLC in federal district court.
In 2015, AniCell Biotech pioneered and created a novel, amnion tissue allograft to be used regeneratively for animals. Quite simply, we are in the recycling business. We non-invasively collect what God created all living things from and we utilize it as a physical bio-scaffold to address wounds in companion animals, delivered by licensed veterinarians. Tissue-based products like demineralized bone matrix and porcine bladder products in animal health are regulated as medical devices by FDA’s Center for Veterinary Medicine (“CVM”). Currently, there is no regulatory language to the contrary.
After we founded the company, FDA’s CVM published a guidance document “Cell-Based Products for Animal Use” to regulate this new category of novel products rather than establishing a formal regulation like it should have. It seeks to categorize all regenerative technologies including tissue-based products as drugs. This was despite the 21st Century Cures Act (signed into law on December 13, 2016) on the human side, which established a significantly less demanding and separate regulatory pathway for tissue-based regenerative products. FDA furthers its unauthorized regulatory overreach in the complaint by stating that products without stem cells can still be drugs under the law yet fails to point to any such provision of relevant statute or regulations.
After eight years in business, 20,000+ treatments with a 94% efficacy rate and zero severe adverse events recorded, AniCell and myself personally, as CEO and Founder, have been named in a complaint from the US DOJ seeking a permanent injunction from the marketing and sale of these products based on some of the language on our previous website and their errant claims that we have never responded to Agency inquiries, never filed an Investigational New Animal Drug application (“INAD”) and never tried to resolve this issue.
To the contrary, AniCell has had several proactive conversations with the FDA regarding the allegations that our regenerative products are drugs, primarily based on how we initially referred to them on the old website. We corrected our website in 2017 to address any FDA language concerns and then led the way in science to show how these products mechanically function as a physical bio-scaffold to achieve the primary intended purpose of wound care. Our regulatory attorneys repeatedly requested meetings with FDA to discuss these issues and have been denied every time. Acknowledging that a difference exists between the regulation of cell-based and acellular tissue products we filed an INAD (INAD file number I-013594) on December 3, 2021, for a cellular therapy, in an attempt to address any lingering concerns. That filing has been overlooked by FDA and is not even mentioned by DOJ in the complaint.
On the other hand, AniCell has successfully worked with the United States Department of Agriculture (“USDA”) for several years on various projects. Under the federal Virus-Serum-Toxin Act of 1913, the USDA has oversight over veterinary biologics. It can be argued that there is significant support for AniCell’s products being biologics falling under USDA’s regulatory jurisdiction and outside FDA’s legal reach. Multiple issues have plagued animal health and at the USDA’s behest, AniCell has achieved a positive impact by being deployed at the request of state agencies to lessen the impact of quarantine periods.
Quite simply, this is an egregious government overreach, and it will impact all aspects of the veterinary regenerative medicine industry and animal health generally going forward. We did not skirt government oversight, as evidenced by the three welcomed FDA inspections of our lab, which are now relied on to prosecute us. It is also interesting to note, that no other regenerative products or companies are being subjected to this same level of scrutiny; we have been made a target.
What does this mean for you? The FDA did not seek either a temporary or permanent restraining order barring the sale of AniCell’s products, and there is no immediate cease and desist order in place. We also believe we are several months from going to trial. So, for us, it is going to be business as usual.
If you would like to help, please pass this on to your local congressional representatives in DC or we have attached a letter below. This egregious governmental targeting cannot stand, and we look forward to our day in court.
Form Letter Template to your Legislator (Modify as you wish)
We have set up the AniCell Legal Defense Fund on GoFundMe to help fight this complaint. Please feel free to forward it to your customers and others who are against government overreach and targeting.
https://www.gofundme.com/f/legal-defense-for-a-anicell-biotech
On behalf of industry, regenerative technology, and the animals we love, we will fight this. We are immensely grateful for the help of our team, customers, other industry members, association partnerships and our local members of Congress. We do not know where this targeting originates but believe “because we said so” should be left to our parents, not the federal government.
Below is both the complaint and the press release:
Complaint
https://www.justice.gov/media/1312231/dl?inline
We refuse to hide from this and will not stand by and be falsely accused. Feel free to contact us at 888-918-2637 or me at 602-918-2637 any time if you have questions.
Forever Thankful
Brandon