As reported in various media, on January 24, 2019 a trucker got into some hot water when he and his big rig were passing through Idaho en route to California from Oregon. In going through a weigh station and having his cargo inspected, state police didn’t take to kindly to what he was transporting.
His haul? Almost 7,000 pounds of hemp.
His customer? A company that intended to wholesale that crop to businesses that manufacture hemp-derived CBD.
Why the fuss? Drug sniffing dogs alerted to his cargo, and field tests indicated the presence (not concentration) of THC. The trucker was immediately apprehended, spent four days in jail, and was freed after posting $100,000 bond.
The company that hired the trucker to transport the product maintains that the load was indeed hemp, that the amount of THC in the hemp was within permissible federal limits, and that it was improperly confiscated. They want it back! So much so, that they’re suing for it; they filed a lawsuit against both the police and the prosecutor.
At the end of July, the U.S. Food and Drug Administration (FDA) issued a press release to alert health care providers and patients regarding the use of energy-based medical devices that are used to perform vaginal “rejuvenation” procedures. Although these devices have been approved to treat certain conditions, such as pre-cancerous lesions in the cervix, they have not been approved for cosmetic rejuvenation. According to the FDA, these procedures have at times been associated with serious adverse events such as burns, scarring, and chronic pain.
Many “rejuvenation” procedures are intended to treat symptoms and/or conditions such as vaginal laxity; pain during sexual intercourse; decreased sexual sensation; and vaginal atrophy, dryness, or itching. The FDA warning noted that it is aware that multiple device manufacturers may be marketing energy-based devices to treat these symptoms and/or conditions even though to date, the agency has not cleared or approved for marketing any energy-based devices to treat theses symptoms and/or conditions.
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.
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.
The regenerative medicine arena consists of a wide range of innovative products. Congress, acknowledging the importance of this field, has established a new program via the 21st Century Cures Act to help spur development and provide for accelerated approval for regenerative medicine products similar to the FDA’s fast track and breakthrough therapy designations. This new approval is the Regenerative Medicine Advanced Therapy (RMAT) Designation.
The RMAT Designation includes all the benefits of the FDA’s other accelerated designations including early agency engagement and priority review; however, unlike the other designations, the RMAT Designation does not require evidence that the product offers substantial improvement over other therapies. For a drug to be eligible for the RMAT Designation, it must meet the following:
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.
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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