Basically what the FDA was saying was that the ELA cells do not meet the criteria in 21 CFR Part 1271 which states that the purpose of this part is to create a unified registration and listing system for establishments that manufacture human cells, tissues, and cellular and tissue based products and to establish donor eligibility, current good tissue practice, and other procedures to prevent the introduction, transmission, and spread of communicable disease by the HCT/P.
If you are an establishment that manufactures HCT/P that are regulated solely under the authority of Section 361 of the PHS Act, this part requires that you register and list your HCT/P's with the FDA's Center for Biologics Evaluation and Research and to comply with the other requirements contained in this part, whether or not the HCT/P's enters into interstate commerce. The HCT/P's that are regulated solely under the authority of Section 361 of the PHS Act.
The HCT/P's must meet the following criteria:
The HCT/P's are minimally manipulated, they are intended for homologous use, reflected by the labeling or other indications of the manufacturer's intent. The HCT/P's do not involve the combination of cells or tissues with another article, except for water, crystalloids, or a sterilizing or preserving agent, providing these agents do not raise new clinical safety concerns.
The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary funcition or the HCT/P's have a systemic effect dependent upon the metabolic activity of living cells.
The HCT/P's are intended for autologous use, is for allogeneic use in 1st or 2nd degree blood relative, is for reproductive use, and if you are a domestic or foreign establishment that manufactures an HCT/P as described you must register with the FDA, you must submit to the FDA a list of each HCT/P manufactured and you must comply with other requirements. Specifically what this letter states is that the product does not meet the criterion in 21 CFR 1271.10(a)(4)(ii)(b) because the product is dependent on the metabolic activity of living cells for its primary function and is not intended for autologous use or allogenic use in a first or second degree blood relative. As a result your ELA cells are drugs 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)].
The letter goes on to state in order to introduce or deliver for introduction a drug that is also a biologic product into interstate commerce, there must be a valid biologics license. The license is only issued after there is a showing of safety and efficacy for the products 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 application in effect as specified by FDA regulations. PureGen OCA is not the subject of an approved biologics license application nor is there an IND in effect. Based on this information, the FDA has determined that your actions violated the ACT and the PHS Act.
Could the potential exist that the parties involved were going for an easier approval process, you be the Judge and the Jury. TSB wants to know what our bloggers think?