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

FDA Stem Cell Guidance Explained: 1271.10(a) Criteria vs. The Same Surgical Procedure Exception

fda stem cell business

fda stem cell business

By: Matthew Fischer

Certain stem cell products fall under the definition of a HCT/P.  If so, unless an exception is met, the product will be subject to regulation by various laws and regulations such as the Food, Drug and Cosmetic Act (“FDCA”), Public Health Safety Act (“PHSA”), and 21 CFR 1271.  When determining which apply, 21 CFR 1271.10(a) and the exception in 21 CFR 1271.15(b) (i.e. the “Same Surgical Procedure Exception”) must be reviewed.  However, many are left asking: what is the relationship between the same surgical procedure exception and the four criteria set forth in 21 CFR 1271.10(a)?  Thanks to recent guidance released by the FDA, some clarification has arrived. Continue reading

Stem Cell Business: 3 Key Considerations for Providers

stem cell businessBy: Matthew Fischer

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.Continue reading

PRP Regulation: How is Platelet-Rich Plasma Regulated by the FDA?

florida pbm companies

PRP RegulationBy: Matthew Fischer

Platelet-Rich Plasma (“PRP”) has become a popular treatment for various conditions from sports injuries to hair rejuvenation so it makes sense that PRP regulation must keep up.  With PRP, both the device used to separate platelets and the subsequent use of the PRP product fall under the scope of the U.S. Food and Drug Administration (“FDA”).  The common question is: what is approved by the FDA with regards to PRP?  Given the increased use, it is important for health care providers to understand the FDA’s standpoint on PRP regulation.

Medical Device Regulation

Let’s start with PRP devices.  Generally, the FDA provides several avenues in which a device, drug, or biologic can come to market.  For medical devices, an applicant can either obtain Premarket Approval (“PMA”) or 510(k) clearance.  Most PRP preparation systems have utilized the 510(k) clearance process.  What is meant by 510(k) clearance?  The 510(k) application process, also known as premarket notification (“PMN”), is for medical devices that are seen as lower risk which are found to be “substantially equivalent” to a previously cleared device.  Under the Food, Drug and Cosmetic Act, device manufacturers are required to register and notify the FDA of the intent to market a medical device in advance.

The FDA then determines whether the device is equivalent to a device already on the market.  The 510(k) clearance process is a common way for PRP devices because it is less costly and time consuming as opposed to obtaining PMA.  There is one important caveat though with 510(k) clearance.  Clearance does not equate to approval for treatment of any indication.  It only applies to its intended use in a specific setting.  For example, in past warning letters issued by the FDA, the agency has required certain manufacturers to add language to its label stating that the PRP prepared by the device had not been evaluated for any clinical indication.  Continue reading

The FDA Inspection and Enforcement Process: A Guide for HCT/P Manufacturers and Providers

stem cell therapyBy: Matthew Fischer

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.  Continue reading

Regenerative Medicine: Navigating New FDA Guidance for HCT/P

stem cell therapy

stem cell therapyBy: Matt Fischer & Susan St. John

The U.S. Food and Drug Administration (FDA) has issued new guidance for regenerative medicine manufacturers and healthcare providers.  At the core of the guidance are two central interpretations: 1) the FDA’s current interpretation of the minimal manipulation and homologous use criteria set forth in 21 CFR Part 1271; and 2) the FDA’s current 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 FDA intends to initiate increased discretionary enforcement over the next 36 months for human cell and tissue-based products.  Given these developments, healthcare companies and providers impacted by this guidance are strongly encouraged to ensure compliance with the FDA’s new interpretations.Continue reading

Compliant STEM Cell Therapy & HCT/Ps: Beginner’s Guide

stem cell therapy compliance

stem cell therapyBy: Susan St. John

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.Continue reading