The FDA published letter to Colorado company detailing how their use of cell is the development of a new biologic drug, and, as such, require a BLA and an IND. What is also fascinating is the language within the letter. The most important, and far reaching statement in the letter is that the cells are being classified as drugs under the section 201 (g) of the Federal Food, Drug, and Cosmetic Act because the cells were not intended for autologous use.

While it is doubtful that this letter can be applied in a broader context, it does point to a continued delineation between autologous applications of cell therapies as the practice of medicine and allogeneic as drug development.  This line in the sand is critical because it defends the right of the physician to apply his or her experience and expertise in treating a condition or disease, and affords a physician the right to innovate based on a one-on-one risk pyramid.

http://tinyurl.com/3ddjnhn

Federal Trade Commission (FTC) and Stem Cell Medicine:

Federal Trade Commission (FTC) and Stem Cell Medicine

The FTC is a large regulatory agency with very broad powers. If you market your services as a physician or offer medical therapies then the FTC can claim jurisdiction. If your ‘marketing’ is in English, it does matter if your clinic or your practice is in Peru, Mexico or China. The FTC is watching and evaluating the claims around stem cell medicine.

The ICMS met with the compliance office of the FTC last week to open a dialogue to provide physician and stem cell therapy providers with information to help them navigate the fine line between patient education and patient recruitment. The simple fact is this: You are subject to Truth in Advertising Laws. And because of the sensational nature of many ‘claims’, the murky regulatory nature about what is legal according to the FDA, and the proliferation of clinics in the US and abroad, our field is under considerable scrutiny. As a field, there are a few basic standards that we should all be working within:

1.       Any claim must be based upon scientific evidence and knowledge that is generally accepted in the field, and

2.       Any claim must be reliable and be shown to consistently reproduce similar results.

Any claim brought before the FTC will be evaluated by experts in the field. The ICMS is working hard to establish our membership as experts to be consulted to evaluate any claim. To do this, we will work collaboratively with the federal government of the USA to develop standards for patient recruitment and appropriate use of medical claims.

If you are currently promoting a therapy on your website, we suggest that you evaluate it to assure that you are in compliance with Truth in Advertising Standards and seek legal counsel if you have any questions.  We will continue to work to provide you with guidelines and standards so that we, as a peer organization, can define the future of cell-based medicine. If you are interested in serving on the committee to help draft these standards, please contact the ICMS.