Regenerative Sciences Faced with FDA Injunction

By William T. Koustas –

We have previously written that Regenerative Sciences (“Regenerative”), a Colorado-based stem cell company, filed a complaint in the U.S. District Court for the District of Columbia against FDA in order to enjoin it from regulating Regenerative’s use of cultured stem cells to treat patients for a variety of ailments (“Regenexx Product”).  In response, FDA recently filed a complaint with the U.S. District Court for the District of Columbia on August 6, 2010 seeking to permanently enjoin Regenerative from using stem cells to treat patients. 

In its June 22nd complaint, Regenerative essentially argued that its Regenexx Product was part of the practice of medicine and thus beyond FDA’s regulatory authority while also noting that the procedure did not involve interstate commerce.  However, in its complaint, FDA has responded by insisting that  Regenerative manufactures a biological product (stem cells) that is adulterated because it is not manufactured according to current good manufacturing practices (“cGMP”) while using components that are shipped in interstate commerce.  FDA v. Regenerative Sciences, LLC et. al., Untied States District Court for the District of Columbia, August 6, 2010 (“Complaint”) at 3, 5.

FDA’s Complaint states that the Regenexx Product is a drug under the FDC Act as it is intended to cure, treat and mitigate disease while also affecting the “structure and function” of the body.  Complaint at 5.  FDA supports this point by referring to Regenerative’s own website and promotional material, which claim that the stem cell procedure “prevents the need for surgery,” is “an Alternative to Traditional Surgery,” and is “shown to be safer than traditional surgical techniques…” Complaint at 6, 7.  FDA further argues that the stem cells are a prescription drug as they should only be used under the supervision of a practitioner as well as a new drug as they are not generally recognized as safe and effective.  Complaint at 7.   

Additionally, FDA’s complaint argues that the Regenexx Product is a biologic under the Public Health Service Act, but not a Human cell, tissue or cellular or tissue-based product (“HCT/P”).  It is a biologic because it is an “analogous product” under the definition of biological product in PHSA 42 U.S.C. § 262(i) as it is used to treat and cure a multitude of conditions, such as osteoarthritis and non-healing fractures.  Complaint at 8.  However, the Regenexx Product is not a HCT/P as the stem cells are more than “minimally manipulated” as required by 21 C.F.R. § 1271.10(a).  Complaint at 9.  Rather, the “expansion of cells in culture does not qualify as ‘minimal manipulation’.”  Complaint at 10. 

Finally, FDA argues that the Regenexx Product is adulterated and misbranded under the FDC Act.  The product is adulterated because it is not manufactured in compliance with cGMP standards (as noted by the prior FDA inspections of Regenerative’s facility) and it is misbranded because the label does not “bear adequate direction for use.”  Complaint at 11, 14.  FDA also points out that, since it asserts that it is a prescription drug product, the label should also note that Regenexx is “Rx only.”  Complaint at 14. 

Though FDA sought an injunction in part based on the fact that Regenerative refused to voluntarily comply with FDA’s request that the company stop manufacturing the Regenexx Product, however, a FDA news release on this issue noted that Regenerative has agreed to discontinue production of the Regenexx Product while this case is pending.  The Court has since issued an order denying Regenerative’s motion for a temporary restraining order in the case filed on June 22, 2010 as moot and entered a stay of that entire case until this case is resolved.

This case is one of the very few injunction suits that the Justice Department, on behalf of FDA, has ever filed in the District of Columbia.  The reason for filing the action here is almost certainly that Regenerative Sciences filed its earlier action here.  Had the Government filed the suit where it normally files injunction cases, namely where the defendant is incorporated or has its principle place of business (Colorado), Regenerative Sciences could have successfully argued that the case needed to be transferred to the District of Columbia.