Stem Cell Controversy #1: Celltex and the FDA
The Food and Drug Administration (FDA) is stepping up its oversight of companies peddling unproven and unlicensed stem-cell therapies. They have just released the stern warning letter they sent in September to Celltex, the controversial Texas company that became notorious after it treated Gov. Rick Perry and was entangled in a separate bioethics scandal. Summaries can be found at Pharmalot and at the Knoepfler Stem Cell Lab Blog (which had several earlier useful posts), while the letter itself is here.
The FDA's letter detailed its complaint that Celltex is illegally marketing an unlicensed drug, as well as reiterating a number of complaints about the company's manufacturing processes. In parallel, the FDA sent what is essentially a cease-and-desist letter (full text) to Texas Applied Biomedical Services, the review board that approved CellTex's activities.
Celltex has responded, disagreeing with the FDA's views on legality but promising to meet FDA requirements "no matter how high the hurdles may be, to ensure access to this technology." The 10-page letter is here, and a press release can be found here.
It certainly seems that the FDA is moving to take control of this nascent and regrettably scandal-ridden industry. By coincidence, they are also being forced to deal with a meningitis outbreak, traced to a pharmacy to which they sent a warning letter in 2006. However, a lack of regulatory clarity is said to have hampered the agency with, in that case, disastrous results. Let us hope that processes and procedures have improved. Stem cell treatments clearly need thorough oversight.
Previously on Biopolitical Times:
- Will the FDA Close Down Celltex?
- The Texas Two-Step: New State Regs Allow Stem Cell Companies to Circumvent FDA Evaluations
- 60 Minutes Exposes Stem Cell Scams — Again
- Stem Cells Update: Clinical Trials, Possible Funds, Long-Range Visions and Short-Term Scams