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.
In a warning letter, the FDA gave Celltex Therapeutics Corp. 15 business days to submit a plan to address the agency's concerns, including correcting previously cited manufacturing problems. The letter said that 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 on Sept. 24 and publicly posted Tuesday.
The letter comes about six months after the FDA made a 10-day inspection of the facilities where Celltex banks and grows stem cells taken from prospective patients. 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 new warning letter reiterates those problems and asks for more information about them.
David Eller, Celltex's CEO, was unavailable 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 previous news release, Eller said Celltex "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. Biological drugs involve living human cells, as opposed to chemically synthesized drugs.
"We are considering all options as we work with the agency toward a resolution," Eller said in the release.
Adult stem cells multiply to replenish dying cells. Long used to treat leukemia and other cancers, they have recently shown promise for tissue repair in other diseases, though most scientists in the field consider them not ready for mainstream use.
Treatment, at a price
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FDA issues warning to local stem cell company