AlloSource Untitled Letter
September 28, 2011
VIA FACSIMILE AND UPS
Mr. Thomas Cycyota
Chief Executive Officer
6278 South Troy Circle
Centennial, CO 80111
Dear Mr. Cycyota:
During an inspection of your firm, AlloSource, Inc., located at 6278 South Troy Circle, Centennial, CO 80111, from April 12, 2010 to May 7, 2010, the Food and Drug Administration (FDA) learned that your AlloStem® product combines processed ---------------------------(b)(4)-------------------------------- demineralized ---(b)(4)---- obtained from processed ---------------(b)(4)---------------- cancellous bone. The product is intended to be used as a bone graft for use by surgeons to promote bone growth and healing.
This cell-scaffold product is a human cell, tissue, or cellular tissue-based product (HCT/P) as defined in 21 CFR 1271.3(d). However, this product is an HCT/P that does not meet all of the criteria in 21 CFR 1271.10(a) and therefore is not regulated solely under section 361 of the Public Health Service Act (PHS Act) and the regulations in 21 CFR Part 1271. Specifically, the product does not meet the criterion in 21 CFR 1271.10(a)(4)(ii)(b) because it is dependent upon the metabolic activity of living cells for its primary function, and is not intended for autologous use or allogeneic use in a first or second degree relative. As a result, your HCT/Ps are drugs as defined under section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)] and biological products as defined in section 351(i) of the PHS Act [42 U.S.C. 262(i)].
Please be advised that in order to introduce or deliver for introduction a drug that is also a biological product into interstate commerce, a valid biologics license must be in effect [21 U.S.C. 355(a); 42 U.S.C. 262(a)]. Such licenses are issued only after a showing of safety and efficacy for the product’s intended use. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an investigational new drug (IND) application in effect as specified by FDA regulations [21 U.S.C. 355(i); 42 U.S.C. 262(a)(3); 21 CFR Part 312). AlloStem® is not the subject of an approved biologics license application (BLA) nor is there an IND in effect. Based on this information, we have determined that your actions have violated the Act and the PHS Act.
This letter is not intended to be an all-inclusive review of the products that your firm may promote and/or market. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act and the PHS Act and their implementing regulations.
We request that you notify this office, in writing, of the steps you have taken or will take to address the violations noted above and to prevent their recurrence. Your response should be sent to me at the following address: U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, HFM-600, 1401 Rockville Pike, Suite 200 N, Rockville Maryland 20852-1448.
If you have any questions regarding this matter, you may contact Ms. Shannon Aldrich at (301) 827-6201. Please be advised that only written communications are considered official.
Mary A. Malarkey
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research