Legal Risk Issues in Regenerative Medicine and Anti-Aging Medicine

One recent story by Patrick J. McKenna in Legal Executive Institute, part of Thomas Reuters, helps to illustrate the ways the regenerative medicine sector is expanding – and how experienced lawyers are working to mitigate the risks of litigation while also helping to meet regulatory compliance issues.

What is Anti-Aging?

Anti-aging medicine is known by similar names or is related to many similar concepts.

A more formal term is biogerontology. This is the scientific name for the biology of aging. Research in this field targets the biological mechanisms of aging so the people can live to a healthier old age. This anti-aging field focuses on diagnosing, understanding, preventing, and trying to cure certain age-related impairments. The research includes:

• discussions on modulating the aging process by physical, chemical and biological means, including transgenic and knockout organisms;
• cell culture systems to develop new approaches and health care products for maintaining or recovering lost biochemical functions;
• immunology, auto-immunity and infection in aging;

The biogerontology field also uses experimental studies and genetics determinants – of plants, micro-organisms, and vertebrates – to help link aging and survival.

Many doctors, physician practices, and healthcare companies in the anti-aging field promote their products and services as being able to extend someone’s life. As with all medical practices, there are federal and state regulations that govern what products and services can do for a patient and when the patient is being promised something that will not work. This includes FDA and FTC regulations and local and state regulations.

Current Anti-Aging and Regenerative Medicine Treatments

As the population ages, people do not just want to live longer, but also to be as healthy as possible during their later years. Some of the treatments that are being used to extend people’s lives while keeping them in good health include:

• Stem cell therapies. Stem cells are used to help repair the body because, in theory, they can continue to divide without any limitation for as long as person is alive. When division occurs, the stem cell can stay a stem cell. It can also grow into muscle cells, red blood cells, brain cells, and cells with special functions.

The stem cells can also become blood, bones, and organs. Stem cell therapies hold the hope of treating diseases that currently do not have cures. Stem cells are also used to determine if drugs are safe.

FDA regulation of stem cells requires that health providers not overpromise or misrepresent what the stem cells can do. Patients in pain and patients who have diseases should have reasonable expectations about if and how well stem cell therapies can work for their disorder. The FDA’s team is reviewing any claims that the stem cells can qualify as drugs. Developers and health provers should expect that FDA and FTC warning letters may be issued if misrepresentation and untruthful promises are made. Healthcare lawyers can help clients understand the legal issues involved with stem cell therapies.

• PRP medicine. PRP stands for Platelet Rich Plasma. A person’s blood has a red liquid part called plasma. The blood also contains red cells, white cells, and platelets. The platelets have a unique ability to help blood clot. Platelets also have proteins which contribute to the healing process.

With PRP the plasma is enriched with the body’s own platelets through an enrichment process. Blood is taken from the patient. The platelets are separated out through a process called centrifugation. The plasma/platelet combination is then injected into the part of the body that hurts or is diseased. PRP is also used to help a patient heal after surgery.

• 3D printed organs.  In just one example, health researchers are working on creating 3D hearts.

Now, scientists at Harvard’s Wyss Institute say they are one step closer to that reality. In lab experiments, the scientists have developed a new technique that uses living human cells to “print” functional heart tissue for an artificial heart — an innovation that could save thousands of lives. If all goes well, the 3D-printed heart will operate like a normal heart. The 3D version of the heart even comes with blood vessels to help the person who receives the transplant. The researchers are trying their process on mice and other animals. If the process works, older people with damaged livers kidneys, and other organs may be able to get a 3D-printed version of those organs too.

• Young blood parabiosis. This new technique is science to some and snake oil to others. Mr. McKenna writes “One particular startup that stirred up a bit of controversy is Ambrosia, which is a private clinic where patients aged 30 to 80 can pay $8,000 to get blood plasma from younger individuals.”
• Genome sequencing. “Whole-genome sequencing (WGS) is a comprehensive method for analyzing entire genomes. Genomic information has been instrumental in identifying inherited disorders, characterizing the mutations that drive cancer progression, and tracking disease outbreaks. Rapidly dropping sequencing costs and the ability to produce large volumes of data with today’s sequencers make whole-genome sequencing a powerful tool for genomics research.”

Artificial intelligence may be another possible anti-aging medical practice.

In one amazing study reported by Mr. McKenna,

“In September, a geneticist at the University of California-Los Angeles reported in a published study how for the first time there may be a possible way to reverse the body’s epigenetic clock, which measures a person’s biological age. For one year, nine healthy volunteers took a cocktail of three common drugs — a growth hormone and two diabetes medications — and on average shed 2.5 years of their biological ages, measured by analyzing markers on a person’s genomes.”

FDA Classification of Nutraceuticals

One well-known type of anti-aging/regenerative products is a nutraceutical. Nutraceuticals to treat age-related diseases. A nutraceutical, or “bioceutical”, is a pharmaceutical product which claims to provide physical benefits. In the US, “Nutraceuticals” are not strongly regulated.

The FDA, through the Food, Drug, and Cosmetic Act, often qualifies these products as:

• Dietary supplement. Dietary supplements are products that contain nutrients from foods. Dietary supplements are usually sold or distributed in capsule, powder, pill, or liquid form. FDA oversight of dietary supplements includes regulations – that are different from drugs and different from other food products.
• Functional food. This category includes whole foods or foods with “enriched or enhanced dietary components that may reduce the risk of chronic disease and provide a health-benefit beyond that traditional nutrients contain.”
• Medical food. Medical food is administered to a patient or consumed by the patient – under a doctor’s supervision. Medical foods are used to treat a specific dietary issue or disease – “for which distinctive nutritional requirements are established by the medical evaluation (on the basis of recognized scientific principle).”
• Farmaceutical. Farmaceuticals are “medically valuable components produced from modified agricultural crops or animals.” Advocates claim that “using crops (and possibly even animals) as pharmaceutical factories is much more cost effective than conventional methods, with higher revenue for agricultural producers.”

FDA regulation of nutraceuticals (and cosmeceuticals which are a hybrid of cosmetics and pharmaceuticals) generally requires focusing on FDA regulations of the component parts

• Cosmetic
• Dietary Supplement
• Drug (prescription (Rx) or OTC)
• Food
• Medical Device
• Medical Food

FDA compliance can mean that hybrids like nutraceuticals need several types of FDA approval – not just one. For example, a nutraceutical may need approval as a drug and as medical food.

Some of the New Businesses Entering the Regenerative Medicine Field

The article by Mr. McKenna provides numerous examples of some of the ways companies are providing new products and services in regenerative medicine.

• AgeX Therapeutics founded in 2017 is working on various technologies along with pipeline drugs to explore pluripotent stem cells, which have the ability to produce any cell or tissue needed in the body to repair itself and replicate indefinitely, making the patient essentially immortal.
• Two companies, LyGenesis and Prellis Biologics are working through the complexities in creating a human organ composed of interconnecting tissues in the hopes of achieving organ regeneration.
• Unity Biotechnology targets senescent cells that cause inflammation and other age-related diseases, and has had many notable healthcare investors including ARCH Venture Partners, Mayo Clinic Ventures, WuXi Healthcare Ventures, Jeff Bezos’ Bezos Expeditions, and Peter Thiel’s Founders Fund.

Notable Mention

Mr. McKenna described our firm’s work in the regenerative medicine field as follows:

“One of the few law firms that has staked out a position in this niche is the California-based Cohen Healthcare Law Group, which specializes in micro-niches like anti-aging practices, biotech and nutraceutical companies, medical device companies, telemedicine ventures, and emerging healthcare technologies. The firm handles matters such as medical practice business formations, mergers and dispute resolution, e-commerce, licensing agreements, and intellectual property protection.”

Why Anti-Aging and Regenerative Medicine Practices and Companies Need Legal Counsel

There are many business issues that need resolution. Some of the core healthcare legal compliance issues involve:

• FDA related services. These include:
  • Understanding the standards for seeking approval for a variety of drugs, dietary supplements, foods, and other products.
  • Responding to warning letters by the FDA regarding non-compliance
  • Preparation to avoid enforcement actions
• Understanding what advertising/marketing is permissible and what ads are not– by both the FDA and the FTC.
• Drafting contracts to form strategic alliances
• Developing compliance plans to reduce the risks associated with anti-aging and regenerative medicine services and products.

Experienced FDA and FTC lawyers also understand when working relationships may violate federal laws such as Stark Law and the Anti-Kickback Statute.  Healthcare lawyers can also, according to Mr. McKenna understand the medical licensing requirements in this new field.

While traditional doctors, such as endocrinologists (who specialize in hormones) and geriatricians (who focus on the elderly) are specifically trained to treat age-related conditions such as hormone imbalances, not all anti-aging doctors have a degree or advanced expertise in what the physicians practice.

Currently, the American Board of Medical Specialties does not recognize “anti-aging” as a specialty – even through the practice has its own professional society — the American Academy of Anti-Aging Medicine (A4M) society – founded in 1992.

The anti-aging and regenerative medical fields are expanding as the elder population wants to live even longer in good health. FDA regulations already regulate most of these innovations. New products and service must comply with both the FD&C Act and the FTC Act. Failure to develop compliance strategies and plans result in warning letters, injunctions, and the closing of the practice or business.

Contact Cohen Healthcare Law Group, PC for legal counsel on healthcare transactions, regulatory compliance, and FDA and FTC law. Our experienced healthcare & FDA attorneys advise healthcare companies and healthcare providers ranging from medical centers, to integrative and functional medicine practices, cosmetics and supplement companies, and medical device manufacturers.