Does the U.S. Need a New Deal on Stem Cell Policy?

Does the U.S. Need a New Deal on Stem Cell Policy?

A. Rahman Ford, JD, PhD

Newly-appointed FDA Commissioner Stephen Hahn may be facing a Rooseveltian moment in stem cell policy.

In the midst of the Great Depression, President Franklin D. Roosevelt instituted his New Deal, a series of reforms aimed at quelling the economic uncertainty that Americans were facing as a result of a devastated economy. In his First Inaugural Address, Pres. Roosevelt famously remarked, “the only thing we have to fear is fear itself – nameless,  unreasoning, unjustified terror which paralyzes needed efforts to convert retreat into advance.”

While certain not as dire as the Great Depression, stem cell policy may likewise be in an uncertain position. Despite its intention to provide clarity in a nebulous regulatory landscape, the current FDA stem cell regulatory framework – found principally in the FDA’s 2017 guidance – has arguably created policy confusion in its practical application. Thus, American stem cell policy may need to be revisited.

Possible re-evaluation could begin with a distinction between autologous and allogeneic therapies, with the states assuming regulatory authority over the former and the FDA assuming authority over the latter. This could make administrative sense for three reasons: (1) it is debatable whether the FDA was ever intended to exercise authority over autologous stem cell therapies (SCT): (2) increased FDA regulation of SCT has been of questionable effectiveness; and (3) states have the required institutional apparatuses to police clinics offering SCT within their respective jurisdictions.

In the context of SCT, the FDA defines “autologous” as the “implantation, transplantation, infusion, or transfer of human cells or tissue back into the individual from whom the cells or tissue were recovered.” Autologous cells are extracted from a parson and then re-administered to that same person. Conversely “allogeneic” SCT use stem cells from another person.

It might be administratively prudent for the FDA to relinquish its regulatory authority over autologous SCT for several reasons. First, autologous therapies were long considered “practice of medicine.” As Teo (2017) notes, “the FDA has always been clear on its stance: it does not regulate the practice of medicine between physicians and patients.” Indeed, a person’s own stem cells were only legally deemed “drugs” in 2006 when the FDA changed 21 CFR 1271, amending “into another human” to “into a human,” according to Michael Freeman and  Mitchell Fuerst.

During FDA administrative hearings in the 1990s, several organizations such as the American Red Cross, the American Society for Clinical Oncology (ASCO) and the Society for Assisted Reproductive Techniques argued that the FDA was only granted authority over allogeneic tissue transplants, to control the transmission of communicable diseases. Since then, the FDA has continued to widen its regulatory scope over autologous therapies. The benefits of its extension of authority have questionable.

Second, the FDA guidance was intended to provide clarity; however, vagueness and ambiguity persist in practice. Disagreement among stem cell researchers, ethicists, industry and clinicians has been pointed and acrimonious to the point of stale mate. One camp advocates for increased FDA regulation and enhanced enforcement efforts against “rogue” SCT clinics. The other camp recommends less-restrictive regulations and a more liberal revision of the FDA Guidance. Both camps agree that current stem cell policy is unsustainable and in need of re-evaluation.

For its part, the FDA has repeatedly issued warning letters to clinics offering unapproved stem cell products. The FDA has also filed federal lawsuits in Florida and California seeking injunctions. At the same time, patient demand is increasing rapidly, as evidenced by the increasing number of clinics offering stem cell therapies. Despite these efforts, nether camp is content with the FDA’s current stem cell policy posture.

Third, the states are institutionally capable of regulating autologous SCT in their respective jurisdictions, through legislation, prosecution or through professional licensing boards. In 2017, Texas Governor Greg Abbott signed a law that makes Texas the first state to authorize the use of SCT for patients with certain severe chronic condition or terminal illnesses. Arkansas is on course to be the first state to require medical insurance companies to cover SCT. New York State Attorney General Letitia James filed a lawsuit against a clinic offering SCT, maintaining that it misled patients with deceptive marketing practices. The Illinois Department of Financial and Professional Regulation is also investigating patient complaints.

For a potential Commissioner Hahn-led stem cell policy New Deal, distinguishing between autologous and allogeneic therapies and allowing states to take the lead on autologous therapies may be a viable first step.

A. Rahman Ford, J.D., Ph.D. is a freelance writer on the topic of stem cell policy. He earned his J.D. from the Howard University School of Law and his Ph.D. in Political Science from the University of Pennsylvania. His writing can be found at https://www.clippings.me/arahmanford.