123s of Regenerative Medicine

September 27, 2021

Regenerative medicine is the most innovative field in contemporary medicine. It lies on the cutting edge of modern science and wellness and has the potential to heal ailments that, in the past, had to be left untreated. In addition, regenerative medicine is used by many as anti-aging therapy to reduce the appearance of scars and wrinkles and to rejuvenate the skin.

But what is regenerative medicine? It is the medical practice that deals with replacing or regenerating human cells, tissues, and organs in such a way that doctors can restore normal function. By replacing damaged tissues with healthy ones (or by simply helping to spur on the healing process), the benefits of regenerative medicine can be life-changing for millions. Unfortunately, these wonder treatments may be novel or unproven, which is why regulatory bodies have a strong interest in regenerative medicine.

While many of the same legal issues addressed in 123s of Plastic Surgery will apply, navigating the complex compliance environment of regenerative medicine can be especially difficult given state and federal laws and medical board regulations are often at odds with one another on concept of regenerative medicine.

Regenerative Medicine and the FDA

The U.S. Food and Drug Administration (FDA) is charged with protecting our public health by ensuring the efficacy of both human and veterinary drugs, medical devices, and biological products.

Although the FDA does not regulate and monitor the practice of medicine, this does not mean their rules have no relevance for healthcare providers. In fact, the FDA is responsible for classifying new types of drugs and medical devices by risk, and they are also responsible for approving new drugs and certain biologics.  And the FDA has had its eyes on regenerative medicine over the last several years: (1) Statement from FDA Commissioner Scott Gottlieb, M.D. on the FDA’s new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine, (2) FDA announces comprehensive regenerative medicine policy framework, (3) FDA Warns About Stem Cell Therapies, (4) Public Safety Notification on Exosome Products, (5) FDA Extends Enforcement Discretion Policy for Certain Regenerative Medicine Products, (6) Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes; and (7) Important Patient and Consumer Information About Regenerative Medicine Therapies.

As a result, when it comes to certain types of regenerative medicine, the FDA’s rules and regulations must be closely followed. This is especially true when involving stem cells, exosomes, or platelet-rich plasma (PRP).  For example, Sections 351 and 361 of the Public Health Service Act give the FDA the authority to establish regulations for all human cells, tissues, cellular-based, and tissue-based medical products (also known as HCT/Ps) with the resulting regulations found at 21 C.F.R. § 1271.  Navigating these rules is no easy task and you must know what is and is not allowed before beginning to practice in this quickly growing field.

There’s More: State Law and Medical Board Regulations

Even if you are able to work through the rules and regulations set out by the FDA, that doesn’t mean you are in the clear. You must now turn your attention to the rules in your particular state which may also not be easy. What works in Arizona could very well be prohibited in Texas.

The practice of regenerative medicine still needs to conform to your state laws in addition to the regulations set out by your state’s medical board. In many cases, these rules add even more on top of the existing regulations established by the FDA. They can even ostensibly conflict with federal regulations. Remaining compliant means being able to find a safe place inside a particularly dense regulatory framework.

Knowing how to conduct your practice in such a complicated compliance environment requires expertise. You not only need to understand the already complex federal rules, but you also need to weigh them against state laws and regulations. 

The Final Hurdle: Remaining Compliant While Advertising for Regenerative Medicine

What has been discussed above are the difficulties in figuring out whether you can even offer regenerative medical service. The next step for any business is to advertise your services. But once again, there are both federal and state regulations to follow.

Since products in the regenerative medicine space can be regulated by the FDA, it also falls under their purview to regulate the advertising of such biological products. In general, the FDA bars any advertising that is false, lacking in fair balance, or otherwise misleading or misbranded. The FDA generally disallows any advertising of off-label uses and any advertising that might recommend or suggest usage other than those approved by the FDA. In one notable case, the FDA put on notice a company promoting stem cell therapies for numerous diseases or conditions, such as dementia and Parkinson’s disease.

Beyond the FDA, there are other federal agencies to consider as well such as the Federal Trade Commission (FTC) which prohibits any form of advertising that could be generally construed as deceptive in one way or another.

Again moving beyond the federal regulations, you must consider state laws. As we mentioned above, each state has different rules and regulations, and these rules can vary greatly when it comes to advertising medical services. However, most follow some form of prohibiting false, deceptive, and misleading advertisements with the differences being how they interpret such language or the type of conduct triggering such issues (i.e. testimonials).

Finally, one must not forget to consider guidance issued by associations, trade associations, or professional societies that may apply. For example, according to the American Medical Association’s Code of Ethics and Opinion 5.02, it is recommended that healthcare providers use advertising that is both non-technical but also not misleading, false, or deceptive. They instead encourage advertising that uses objective claims to highlight experience, competence, and the quality of services. 

All of these laws intersect in complicated and diverse ways. Remaining compliant while advertising for regenerative medicine, no different from practicing it, must be handled individually.

Knowing What’s What

The only way to know exactly where you stand in such a complicated legal and regulatory environment is to work with experts. Regenerative medicine is an incredibly complicated field in terms of regulation, and the penalties can be dire for even the smallest of infractions.

If you have questions about how to remain compliant while practicing regenerative medicine, schedule a consultation at info@byrdadatto.com.

ByrdAdatto attorney Jay Reyero

Jay D. Reyero

Jay has mastered the art of communication, leaving clients with both an understanding of their business risk and the path to solution.