Docstoc

FDA Seeks Injunction Against

Document Sample
FDA Seeks Injunction Against Powered By Docstoc
					The U.S. Food and Drug Administration is seeking an injunction in federal court
against Regenerative Sciences LLC, of Broomfield, Colo., citing violations of
current good manufacturing practice (cGMP) that cause its cultured cell product
to be adulterated. The product is also misbranded due to the lack of adequate
directions for use and the failure to bear the "Rx only" symbol.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

The company's cultured cell product is derived from a patient's bone marrow or
fluid surrounding the patient's joints (synovial fluid). The cells are grown,
processed, and mixed with drug products outside the body before being injected
back into the patient.

Regenerative Sciences' cultured cell product is not approved by the FDA, and no
adequate and well-controlled studies have been done to demonstrate its safety
or effectiveness for any indication.

"FDA recognizes the importance of the development of novel and promising new
therapies," said Karen Midthun, M.D., acting director of FDA's Center for
Biologics Evaluation and Research. "However, when companies like
Regenerative Sciences fail to comply with FDA laws and regulations, they put the
public's health at risk."

The complaint for the injunction was filed Aug. 6, 2010, by the Justice
Department on behalf of the FDA in the U.S. District Court for the District of
Columbia, against Regenerative Sciences and three of its employees,
Christopher J. Centeno, M.D., John R. Schultz, M.D., and Michelle R. Cheever.
The injunction would permanently prevent the company and cited individuals
from adulterating and misbranding the cultured cell product while the product, or
one or more of its components, is held for sale after shipment in interstate
commerce.

Regenerative Sciences has agreed to cease production of the cultured cell
product while the case is pending.

The FDA warned Regenerative Sciences about its cGMP violations as recently
as June 2010. The company failed to make sufficient corrections, and the
conduct of the individuals cited in the complaint demonstrates refusal to comply
with the law.

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:11
posted:8/7/2010
language:English
pages:2