Bass, Berry & Sims attorneys Danielle Sloane and Jansen Carver examined a request by the Association of American Physicians and Surgeons (AAPS) asking the U.S. Supreme Court to take up a case regarding the U.S. Food and Drug Administration’s (FDA) authority to regulate some stem cell procedures. At issue is a recent decision by the Ninth Circuit, overturning a lower court decision, that would allow the FDA to qualify stem cells as a drug when used in a procedure to remove and replant the patient’s stem cells. This would add significant administrative burden to stem cell procedures.
As Danielle and Jansen explain, the AAPS is asking the Supreme Court to reverse the Ninth Circuit’s decision, arguing that “(1) preventing interference with the use of a patient’s own stem cells is of immense national importance; (2) the reasoning of the Ninth Circuit conflicts with Federal Circuit and Supreme Court decisions concerning whether a naturally occurring material can be ‘owned or controlled’ as if it were a drug; and (3) the decision is unauthorized interference with state autonomy over the practice of medicine.” The authors note that the AAPS stresses, “the FDA is attempting to own and control people’s own biological material, and doing so carries significance beyond economic impacts.”
The healthcare industry is closely watching the case following the recent Supreme Court ruling limiting the FDA’s authority to regulate laboratory developed tests as medical devices.
The full article, “AAPS Supports Request for the U.S. Supreme Court to Review FDA Authority to Regulate Certain Stem Cell Procedures,” was published by the AHLA’s Life Sciences Practice Group on July 22 and is available online (membership required to read full content).