FDA Actions Against Celltex, Regeneron “Stifle Innovation,” Gov. Rick Perry Says
This article was originally published in The Pink Sheet Daily
Executive Summary
The governor of Texas criticized FDA’s policies on use of autologous adult stem cells; the agency says stem cells used to treat patients are drug products.
Texas Governor Rick Perry criticized FDA’s regulatory actions against two stem cell companies at the Forbes healthcare summit in New York.
The agency’s position is “incredibly stifling to innovation,” Perry stated.
Perry was asked about his experience using autologous adult stem cells during a Q&A session with Steve Forbes, chairman and editor-in-chief of Forbes Media, at the Dec. 5 meeting. Perry did not mention the companies FDA has gone after by name but noted that one them is based in Colorado and the other in Texas. The Texas company, Celltex Therapeutics Corp., stored and grew the stem cells used in Perry’s back surgery last year.
FDA sent Celltex a letter in September saying the process it uses to multiply adult stem cells is subject to FDA regulation as biologic drug manufacturing. As a result, the stem cell treatments must go through the new drug approval process (Also see "Celltex’s Stem Cell Manufacturing To Be Regulated As A Biological Drug" - Pink Sheet, 2 Oct, 2012.).
The Colorado company, Regenerative Science LLC, engaged in a lengthy legal battle with FDA over its Regenexx Procedure, in which mesenchymal stem cells are isolated from bone marrow, grown to greater numbers, and then placed back into the patient’s injured area to repair it.
Court Rules Stem Cell Procedure Constitutes A “Drug”
FDA sent a letter to the company in 2008, saying it believed the cell product used in the procedure was a biological drug. Regenerative filed suit against FDA in the U.S. District Court for the District of Colorado arguing that the agency did not have jurisdiction to regulate autologous use of stem cells. The court dismissed the complaint on grounds of ripeness in March 2010. The company then filed another complaint in the U.S. District Court for the District of Columbia challenging FDA’s determination that it is a drug manufacturer.
The D.C. district court ruled in July 2012 that the Regenexx Procedure is subject to FDA enforcement because it constitutes a “drug” and has been shipped in interstate commerce. The court issued an injunction precluding the use of the procedure unless it is in compliance with the Food, Drug, and Cosmetic Act.
Perry said he did not understand how FDA could consider minimal manipulation of autologous stem cells to be a drug while not finding bone marrow transplants, transfusions of one’s own blood and in vitro fertilization to be drugs.
Perry has pushed for changes in stem cell policies in Texas. In April the Texas Medical Board approved new rules on the use of stem cells, which require administration to be conducted by a licensed physician as part of a clinical trial approved by FDA or by an accredited institutional review board.
A spokesperson for the Texas Medical Board said the rules were intended to provide “a baseline of patient safety while the issue of stem cell use beyond minimal manipulation is addressed by FDA.” She said anyone doing stem cell procedures in Texas has to follow FDA regulations regardless of what the Board’s rules state.
But Perry said that the oversight and rules put in place by the Texas Medical Board “are quite sufficient.”