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.
There are no off the shelf solutions when it comes to starting a new stem cell business or adding a new component to a practice. Between navigating regulations, receiving training, and marketing the service, there’s a lot to address in a short time. Trying to do it all yourself? You may be a highly trained clinician, but given healthcare’s ever-changing regulatory environment, seeking out experienced counsel at the outset will save lots of time and money in the long run. To get started, here is a short summary of what to expect.
Stem Cell Business – Corporate Structure
The first issue is always protection when starting a business or adding a new service. Take the case of an orthopedic physician that wants to add stem cell treatments (e.g. PRP) to his or her practice. The initial inclination is usually to create a new entity separate from the medical practice. What the physician is likely unaware of is that this may create exposure to state self-referral laws. Typically, under these types of laws, intent is not a requirement to find a physician liable for wrongdoing. Therefore, is it important to determine if your state has this type of law and if so, how to structure the new venture before moving forward.
The U.S. Food and Drug Administration (“FDA”) has implemented a tiered, risk approach to the regulation of human cells, tissues, and cellular and tissue-based products (“HCT/Ps”). HCT/Ps, essentially stem cell business, that meet certain criteria under 21 CFR 1271 are only subject to limited regulation and have no requirement to obtain full premarket approval. An analysis of recent warning letters and inspectional data reveals that the FDA continues to crack down on health care providers and manufacturers offering to use adipose stromal vascular fraction (“SVF”) products to treat a wide variety of conditions. The common conclusion by the FDA: SVF products are more than minimally manipulated and not intended for homologous use meaning that pre-market approval is required.
In November 2017, the U.S. Food and Drug Administration (FDA) issued new guidance regarding its current interpretation of the minimal manipulation and homologous use criteria set forth in 21 CFR Part 1271(a) and the agency’s view on the same surgical procedure exception under 21 CFR 1271.15(b). Additionally, the FDA issued a notice to all interested stakeholders that the agency intends to initiate increased discretionary enforcement over the next 36 months for HCT/P businesses. Based on the agency’s latest position, it is important for HCT/P manufacturers and providers to understand the inspection process and be prepared to respond accordingly in this heightened regulatory environment.
The FDA is tasked with regulating HCT/Ps under the authority of Section 361 of the Public Health Service Act (PHS). Within the FDA, the Center for Biologics Evaluation and Research (CBER) is responsible for ensuring the safety of these products and promoting corrective action. In order to reach this goal, CBER is armed with an array of administrative actions to address violations of regulatory significance.
Many practitioners or establishments looking to enhance their practice and offer more treatment options to their patients are considering HCT/P and Stem Cell Therapy in addition to other traditional treatment options. However, before embarking on offering HCT/P or STEM Cell Therapy, a practitioner or establishment needs to carefully consider protocol and procedure for offering HCT/Ps or STEM Cell Therapy.
The FDA defines HCT/Ps as “articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion or transfer into a human recipient.” 21 CFR 1271.3(d). HCT/Ps include bone, ligament, skin, dura mater, heart valve, cornea, hematopoietic stem/progenitor cells derived from peripheral and cord blood, manipulated autologous chondrocytes, epithelial cells on a synthetic matrix, and semen or other reproductive tissue.
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