From the Houston Chronicle:
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 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.
If Rick Perry were not the governor of Texas, not to mention a prospective candidate for president, this story would be of little consequence. But Perry's willingness to submit himself to a medical procedure that was not approved by the FDA (and to lobby the Texas State Board of Medical Examiners to approve it for general use in Texas) raises serious questions about his judgment.
Perry surely knew from his doctors that the adult stem cells procedure had never been approved by the FDA, but he went ahead with it anyway. This will become known if he runs for president. I wrote at the time that it was a reckless action by Perry. He should make his medical records public.
- 1 week