Over the previous four posts, I have reviewed the FTC’s legal actions taken against a physician who advertised what I call miraculous regenerative medicine on the Internet, in which amazing claims of therapeutic benefit were announced for treating virtually any pathologic condition, including ALS, MS, COPD, chronic kidney disease, autism, etc. I provided examples from the now-defunct website Dr. Bryn Henderson used in promoting his claims of miraculous therapeutic outcomes based on the use of amniotic stem cells, and I reviewed the legal arguments the FTC stated in what became a final Order outlining the sins committed by Dr. Henderson in his clinics, the agreement by Dr. Henderson to pay a hefty fine and to cease making health-related claims for anything without substantial proof and clinical support.
What should grab the attention of physicians who thought they, too, could advertise their practice of miraculous regenerative medicine, is the framework the FTC laid out in the Order that defines how health-related claims in regenerative medicine will need to be supported. The burden is set very high—only results obtained in Level 1 clinical studies performed by experts in the diseases being treated will constitute acceptable clinical evidence of benefit. So, no longer can a physician make claims to support a practice of regenerative medicine, based on their use of a therapeutic preparation, or relying on animal and in vitro studies.
What the FTC achieved in this one case should send shock waves through the regenerative medical community, including the hawkers of unsubstantiated therapeutic preparations like Wharton’s Jelly-derived stem cell preparations, amniotic stem cells or cord blood-derived anything. I mention the purveyors of magical treatments de jour, since their appeal to physicians now will be all the harder, if physicians understand the implications of the FTC-favorable ruling. For example, physicians no longer will be able to advertise that they are using the “richest”, most youthful donor-derived preparations of amniotic stem cells, based solely on the white papers concocted by the sellers of these magical preparations.
In a new wrinkle, the FDA recently announced that it had sent “letters” to more than 20 manufacturers, clinics and health care providers that it determined had not been heeding the comments contained in the two Guidances the FDA issued in November 2017. FDA Commissioner Gottlieb stated the following in his press release:
“…Even though a few sponsors have come to us, we are discouraged by the overall lack of manufacturers wanting to interact with the agency in this enforcement discretion period. The letters we’re issuing today to manufacturers, health care providers and clinics around the country are a reminder that there’s a clear line between appropriate development of these products and practices that sidestep important regulatory controls needed to protect patients. Time is running out for firms to come into compliance during our period of enforcement discretion. We’ll be increasing our oversight related to cell-based regenerative medicine as part of our comprehensive plan to promote beneficial innovation while protecting patients.”
Although the writing has been on the wall since at least November 2017 that the FDA would enforce with fidelity the requirements of 21 CFR 1271 (the regulation that governs human-derived materials when used as an allogenic therapy), it wasn’t clear how the FDA would accomplish this goal. It is clear now that there is a two-pronged effort underway. The FDA-prong involves the Agency sending out letters (that aren’t Warning or Untitled letters) to those they believe are in violation of offering for sale or of using allogeneic products that lack proper regulatory oversight or of using autologous materials like adipose tissue to treat musculoskeletal conditions, among other potential sins. The other prong is exemplified by the recently concluded FTC action against a clinician who paid no attention to the need to provide clinically-supported evidence to back up what the FTC called fraudulent advertising and making false claims.
The fact that the FDA has identified 20 or more entities and individuals who warranted receipt of this new type of letter, means the FTC has multiple, specific targets to review for possible false and mis-leading advertising. And just because you are a manufacturer of miracle goop products, like the already targeted amniotic stem cells, doesn’t let you off the hook, since most companies have websites that make claims at some level about the products they offer, which now will need to be supported by data obtained in Level 1 clinical trials.
When the FDA issued their final Guidances in November 2017, there was some pessimism expressed about the hawkers of miraculous goop having three years to make money and then close up shop. However, with the introduction of several programs mandated by the language of the 21st Century Cures Act that was passed in 2016, the FDA has offered to clinicians and manufacturers of regenerative cell-based therapeutic products the opportunity to perform the studies needed to continue to offer for sale HCT/P-derived materials that currently aren’t compliant, but which remain popular. It is these specific programs that were cited by the Commissioner in the press release that haven’t been embraced by the community. Of course, if you embrace the programs, like RMAT, you are committing your company or clinic to spending millions of dollars to perform studies the FDA requires for HCT/P-derived drugs and biological products in the IND pathway. If your company sells a device or kit that can be used to make non-compliant autologous HCT/Ps for treatment, you will need to perform studies in an IDE framework. The FDA has a program available regardless of what you want to sell or use, but there is a hefty price tag associated with the process.
Consequently, with the FTC hammering physicians who want to advertise their use of miraculous goop (e.g., amniotic stem cells) and the FDA sending out letters to entities and physicians that haven’t been in touch yet reminding them that they should reach out to the FDA, these entities won’t have another couple of years to make money, before the jig is up. The jig is up now and the legal consequences of ignoring the FDA become much greater with each passing day.
At the moment, the focus of the FDA and FTC actions seem to be on manufacturers and health care providers who are involved with miraculous goop products, but there are some interesting considerations and potential implications for some of the more traditional therapies, like BMC and PRP treatments. I will cover these implications in the next post.