Tissue or a Drug?
Should the US Food and Drug Administration (FDA) have the authority to regulate cells derived from—and later put back into—a person?
A recent opinion-editorial published in The Wall Street Journal by former FDA Associate Commissioner Scott Gottlieb and Coleen Klasmeier, head of FDA practice at the law firm Sidley Austin LLP, argues FDA’s efforts to increase regulatory enforcement against stem cell manufacturers has the potential to backfire against the nascent and potentially promising industry.
At issue, write Gottlieb and Klasmeier—both of whom have an admitted financial interest in stem cell therapies—is a recent court case decided in favor of FDA by the US District Court in Washington, DC. In US v. Regenerative Sciences LLC, Judge Rosemary Collyer decided FDA had correctly interpreted its regulations by classifying certain stem cells manufactured by Regenerative Sciences as drugs and biological products.
Tissue or Drug?
According to FDA, the company had subjected itself to FDA regulations by extracting mesenchymal stem cells, which were then cultured and grown before being injected back into a patient for therapeutic purposes. Collyer backed up FDA’s assertions in her 23 July 2012 ruling against Regenerative Sciences, saying FDA’s definition of “drug” was met in this particular case because of its intended use and violation of the “minimal manipulation” standard required to avoid FDA regulation. (Read More By Alexander Gaffney)