FDA issues warning to BioMed IRB over its practices

The Bio Medical Research Institute of America (BioMed IRB) is in hot water with the FDA, which has issued a warning letter to the nonprofit institutional review board after 2010 and 2011 investigations into its practices.

In its warning letter, the FDA cited numerous violations against San Diego-based BioMed IRB, ranging from lacking the "professional competence necessary to adequately review the specific research activities," to failure to "prepare, maintain, and follow adequate written procedures for conducting the review of research." As a result, the FDA will withhold approval of all new BioMed IRB studies, while banning new subjects from joining current, BioMed-approved trials until further review.

While vowing to comply with the FDA's decision, BioMed IRB maintains its innocence in a response to the government body. When accused of not using a medical professional--a physician, as cited by the FDA--in its review of a study with Type 1 diabetes subjects, BioMed IRB asserts that the opinion it used from individuals, including one with a Ph.D. in molecular and medical pharmacology, was sufficient enough. BioMed IRB also maintains that it did in fact have board members vote on trials, while the FDA says otherwise.

As BioMed IRB defines one on its website, an IRB, or institutional review board, has the responsibility to overlook clinical trials and ensure that the risks to subjects partaking in them are as low as possible. But as Outsourcing-Pharma describes in its story, BioMed IRB is accused of taking liberties with subjects, like approving amendments to dramatically increase experimental drug dosages in some trials. As we saw what happened to Cetero Research after its scathing report from the FDA, BioMed IRB's reputation could be in serious jeopardy. Its integrity and future may rest on whether the FDA accepts its rebuttal to the warning letter.

- here's the Outsourcing-Pharma story
- get the FDA warning letter
- and here's BioMed IRB's response (.pdf)