FDA’s recent warning letters target BIMO violations, unapproved products

The US Food and Drug Administration (FDA) recently warned a clinical investigator for informed consent lapses and two companies for marketing unapproved stem cell products.

BIMO violations

In a warning letter to clinical investigator Americo Padilla and the Miami Dade Medical Research Institute, an investigator from FDA’s Center for Drug Evaluation and Research identified “objectionable conditions” related to the conduct of two trials. The warning letter states that the site failed to obtain the necessary informed consent for an investigational high-risk drug that was being administered to pediatric patients at the Miami Dade Medical Research Institute.

This inspection was conducted as a part of FDA’s Bioresearch Monitoring Program (BIMO), which includes inspections designed to evaluate the conduct of research and to help protect human subjects' rights, safety, and welfare.

The investigational drug studied was classified as high-risk and required children between ages six to 18 to obtain permission from a parent or guardian to participate.

“You failed to obtain legally effective written consent from two subjects before their enrollment in Protocol (b)(4), because you did not obtain permission from the subjects’ parent or guardian before the subjects’ enrollment in the study,” FDA wrote.

After completing a 28-day screening phase and before enrolling in the trials, two subjects were enrolled after relatives who were not their parent or guardian signed the informed consent form. In both cases, parental permission was not obtained from the subjects’ parents until several months later.

The clinical investigator attributed the root cause to “errors and deficiencies in the documentation process of legal guardians’ representatives regarding participation in the study.”

FDA said the investigators have 15 days to describe remedial actions taken to prevent similar violations in the future.

Unapproved products

FDA’s Center for Biologics Evaluation and Research (CBER) issued a warning letter on 30 December to New York, NY-based Evolutionary Biologics regarding its marketing of unapproved new drugs and unlicensed biological products after reviewing the company’s promotional claims on its website.

FDA said the exosome products EXO RNA (exosome product), EVO JEL (an umbilical cord-derived product), and EVO HYBRID (a cellular product derived from umbilical cord, “placental tissue,” and amniotic membrane) are unapproved new drugs and are also unlicensed biological products. FDA said the products are marketed with claims to decrease to treat inflammation, osteoarthritis but the firm has not sought the agency’s approval to market them.

The agency also sent Chatsworth, California-based Chara Biologics a similarly worded warning letter for marketing exosome products to treat or cure diseases without an approved BLA or an investigational new drug application (IND).

According to the warning letter, the company manufactures and distributes a human amniotic fluid product, CharaExo, and cellular products derived from human umbilical cord, marketed as CharaCore and CharaOmni, for allogeneic use.

The company’s website claims these products can treat various autoimmune disorders, neurodegenerative conditions such as Parkinson’s disease, Alzheimer’s disease, multiple sclerosis, diabetes, cardiovascular and lung diseases, autism, spinal cord injuries, and cirrhosis.

FDA said that both companies’ products do not meet the exception criteria for HCT/Ps laid out in 21 CFR 1271.10(a) and the criteria under 21 CFR 1271.15 and thus do not qualify for regulation solely under section 361 of the Public Health Service Act and instead are regulated under the Public Health Service Act and/or the Federal Food, Drug, and Cosmetic Act.

Both firms have 15 days to respond to their respective warning letters.

Warning Letters: Americo Padilla/Miami Dade Medical Research Institute, Evolutionary Biologics, Chara Biologics

FDA’s recent warning letters target BIMO violations, unapproved products

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