Regenerative Sciences, Inc. Attempts to Avoid FDA Action

June 27, 2010

By William T. Koustas

Regenerative Sciences, Inc. (“Regenerative”) filed a complaint in the U.S. District Court for the District of Columbia against FDA on June 22nd in order to prevent FDA from essentially closing the business.  Regenerative owns a procedure by which physicians take bone marrow and blood samples from a patient, culture the stem cells, and place them back in the patient’s damaged joint in order to repair it (“Regenexx Procedure”).  Regenerative Sciences, Inc. v. FDA, United States District Court for the District of Columbia, June 22, 2010 (“Complaint”).  The Regenexx Procedure is exclusively licensed for use at the clinic where the inventors of the procedure practice.  Complaint at 2.  However, FDA appears to consider Regenerative a drug manufacturer and the stem cells it cultures in its Regenexx Procedure to be biological drugs, and thus claiming that Regenerative is manufacturing an unapproved drug.  Complaint at 8. 

FDA conduced an inspection of Regenerative’s facility in February and March of 2009, which culminated in FDA issuing a Form 483.  Complaint at 8.  Then, FDA returned to inspect Regenerative again earlier this month and again issued another Form 483.  According to the complaint, an FDA investigator threatened that FDA would issue a warning letter, cease and desist letter, civil penalties and seek an injunction if Regenerative did not correct the deficiencies found during the inspection.  Complaint at 7.  Regenerative claims that correcting the deficiencies found in the inspection would bankrupt it.  Complaint at 3. 

Regenerative argues that the Regenexx Procedure is the practice of medicine and is beyond the scope of FDA’s regulatory authority as provided in the U.S. Food, Drug & Cosmetic Act as well as the Public Health Service Act.  Complaint at 12.  Regenerative contends that the manipulation of stem cells occurs in the normal course of a medical practice which is regulated by Colorado.  Further, Regenerative stresses that the Regenexx Procedure occurs completely within the state of Colorado and is therefore not subject to FDA’s authority because it does not engage in the interstate sale of drugs.  Complaint at 14.  Regenerative also asserts a due process argument in that FDA’s actions violate the Due Process Clause of the Fifth Amendment as it will force Regenerative to go out of business.  Complaint at 17.  The complaint requests that the Court enjoin FDA from regulating the Regenexx Procedure, issuing a cease and desist letter and from ex-parte action by FDA to prevent the use of the Regenexx Procedure.  (A related case filed in the U.S. District Court for the District of Colorado was dismissed earlier this year and has been appealed to the U.S. Court of Appeals for the Tenth Circuit.)

Categories: Drug Development