The Food and Drug Administration has informed the Sugar Land company involved in Gov. Rick Perry's adult stem-cell procedure that it is illegally marketing an unlicensed drug without agency approval.
In a warning letter stepping up the pressure on Celltex Theraupeutics Corp., the FDA gave the company 15 business days to submit a plan to address agency concerns, including correcting previously cited manufacturing problems. The letter said failure to respond promptly could result in seizure or injunction by the FDA.
"Based on (our) information, your product violates the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act," says the letter, sent to Celltex Sept. 24 and publicly posted Tuesday. "Please provide details as to how you plan to deal with the drugs that have already been manufactured at your facility."
The letter comes about six months after the FDA made an 10-day inspection of Celltex's facilities. The agency subsequently filed a report, obtained by the Chronicle in June, detailing dozens of manufacturing deficiencies, from incorrectly labeled products to failed sterility tests. The warning letter spells out how many of the problems still exist.
David Eller, Celltex's CEO, was traveling and unavailable for comment Tuesday, but a public relations official said the company on Wednesday would make available a redacted copy of its letter to the FDA.
In a previously issued press release, Eller said the company "respectfully but firmly" disagreed with the FDA's position that its process causes the cells to be considered biological drugs and thus subject to the federal agency's regulations.
"We are considering all options as we work with the agency toward a resolution," the press release said.
Adult stem cells multiply to replenish dying cells. Long used to treat leukemia and other cancers, they have shown promise for tissue repair in many other diseases in the last decade, though most scientists in the field consider them not ready for mainstream use.
Celltex has been in the public eye since it was revealed that Perry's Houston doctor treated him with his own stem cells during back surgery in July 2011 and in follow-up appointments. Perry's stem cells were stored and grown at Celltex.
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