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:
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.
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.
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.
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