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.
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.
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.
In a time of diminished reimbursement and intense challenge in providing quality medical care when patient volume is maximized: adding a low risk, cash component to your practice may be just what the doctor ordered. Success in recent clinical trials and strong celebrity endorsement and visibility has stimulated interest and demand for PRP (Platelet Rich Plasma) therapy in an array of treatment applications. Recent Google statistics show that “PRP Therapy” was searched for 62,050 times per month locally over the past 30 days alone!
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