US Court: Stem Cells may be Regulated as Drugs

Posted 27 July 2012 | By

The US District Court in Washington, DC, has ruled that the US Food and Drug Administration (FDA) may legally regulate stem cell therapies as drug products-an opening salvo in what is likely to be a lengthy court battle between the agency and a company accused of violating federal regulations.

The entire case results from a 2008 enforcement activity by FDA in which it found Colorado-based Regenerative Sciences to be in violation of federal law.

In a 2008 warning letter, FDA's Center for Biologics Evaluation and Research (CBER) said the company's use of mesenchymal stem cells was violating FDA's regulations on "minimal manipulation," causing them to be drugs.

"Based on information posted on your website, mesenchymal stem cells utilized in your Regenexx™ procedure are drawn from a patient's bone marrow, sent to a lab, isolated, and then grown using growth factors drawn from the patient's blood before being inserted back into the patient," Mary Malarkey, then director of CBER, wrote in the warning letter. "These cells are considered drugs because the therapeutic claims shown on your website demonstrate that they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man."

Under ordinary, homologous uses, human tissues are subject to a separate branch of regulations contained within section 1271 of the Code of Federal Regulations. FDA has since taken regulatory actions against several other stem cell clinics for similar infractions (See Regulatory Focus' 2 May Story, "FDA Warning Letter Cites Company for Breaking HCT/P Regulations"), and the court case could have a wider precedence should the agency lose on appeal, reports New Scientist.

In 2010, Regenerative Sciences filed a lawsuit against the agency, challenging its characterization of its product as a "drug."

On 23 July 2012, US District Court Judge Rosemary M. Collyer sided with the agency, saying the definition of "drug"-"articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease or articles (other than food) intended to affect the structure of any function of the body of man or other animals"-was in fact met under FDA's interpretations. Collyer noted her interpretation drew upon legal precedent and was "well established."

Officials from Regenerative Sciences meanwhile told New Scientist they plan to appeal the ruling.

Read more:


New Scientist - Ruling frees FDA to crack down on stem cell clinics

FDA Law Blog - The Regenerative Sciences - FDA Court Struggle Ends . . . For Now


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