FDA’s Discretionary Enforcement Period Is Ending
Availability of the Section 361 exemption from the far more rigorous requirements of FDA’s device, drug and biologic registration process has spawned a cottage industry of “stem cell and regenerative medicine clinics” that operate somewhere between the fringe of propriety and outright defiance of Federal regulations. According to industry observers, there are currently over 1,000 such clinics and even more physician practices using HCT/Ps that do not actually qualify for exemption.
This naturally raises the question as to where the responsibility for such violations of Federal law reside. Do the physicians who practice the art of medicine bear the brunt of this, or do the companies that manufacture and sell products under the grey areas of Section 361 exemption shoulder that burden?
What is the liability of physicians and hospitals who use tools and instruments sold by companies to prepare tissues in their facilities that do not fit the criteria for Section 361? As physicians promote their practices online with advertisements that claim to use “stem cells” and other materials capable of regenerating tissue, without scientific evidence or FDA approval to make such claims, who is responsible for the false advertising?
In November 2017, the FDA issued a formal guidance document which stipulated that the agency would take a “risk-based” approach to enforcing the updated regulations against those in violation through November 2020, with the intent of giving sponsors the opportunity to bring their development and marketing activities into compliance. A number of orthopedic and tissue repair companies have properly availed themselves to this opportunity and met with FDA to migrate their development programs into well-defined device, drug, biologic or combination product pathways.
However, a great many firms remain that have continued to launch and promote products inappropriately, placing themselves and their physician customers at risk, along with unsuspecting patients who naively believe their unsubstantiated claims. For example, the indisputable fact that there are no approved “stem cell” products to treat any musculoskeletal conditions in the United States has not thwarted some companies and even more doctors from promoting their brand of HCT/Ps as a “regenerative cure” for osteoarthritis, disc degeneration, tendonitis, meniscal injury, torn ACL and many other conditions.
This needs to stop, lest we soil our broader community of healthcare providers who seek to do the right thing for our patients and customers.
What Can and Will Happen to “Bad Actors”?
The FDA, FTC [Federal Trade Commission] and State Medical Boards are authorized to take action against firms and individuals found to be in violation of the laws and regulations governing human medical products. Examples of violations include issues with manufacturing processes, lack of appropriate marketing authorization and advertising products for uses not approved by FDA. This is often discovered during facility inspections and review of company and physician website materials. Specific enforcement activities include actions to correct and prevent violations, removal of “adulterated” products from the market and punishment of offenders. The type of enforcement activity that the authorities use will depend upon the nature of the violation. In the extreme, FDA and FTC can and do work with the Federal Government to write injunctions and cease and desist orders, and they have the ability to levy financial damages on companies and individuals, as well as criminally prosecute those responsible for the noncompliance. These are serious matters, and neither FDA nor the FTC’s jurisdictional reach should be taken lightly.
In conclusion, as we dive deeper into the Age of Biology with incredibly powerful tools to effect tissue repair and regeneration, we must hold ourselves and our HCP colleagues to exceedingly high standards. We must educate our physician customers in not only the basic and clinical science, but the regulatory framework for proper product promotion and use. In this way, we can effectively manage the expectations of patients, deliver high quality care and allow the high tide of success to raise all well-constructed boats that venture into these turbulent waters.
Dr. Bruder founded the Bruder Consulting & Venture Group in 2015 after 25 years in the industrial sector, serving in the C-suites of Stryker, BD [Becton, Dickinson and Co.] and DePuy/Johnson & Johnson. In addition to his tenure through industry, Dr. Bruder has maintained an active academic presence, serving as an Adjunct Professor of Orthopaedic Surgery and Biomedical Engineering at Case Western Reserve University since 1998. Currently, he also serves on the Board of Directors of publicly held medical device companies in the U.S. and Europe. He can be reached at scott@bruderconsulting.com.
