DNAprint Genomics (DNAG)

[mingwan0]

Johnson & Johnson submission to FDA

Here is J&J's submission to the FDA regarding their proposed pharmacogenomic data submission guidelines (it is the only one I can see on the FDA site):

http://www.fda.gov/ohrms/dockets/dailys/04/jan04/012204/03D-0497_emc-000001-02.pdf

In a wide-ranging response there is a lot of identification of issues that they would like further clarification on from the FDA, together with questions about the responsibility for certain functions. There is also a clear theme related to "flexibility". This is a typical example:

"Restrictive standards on the data format and validation could discourage certain companies from submitting genomic data and possibly even discourage companies from engaging in PGx activities altogether. The standards may apply more to one platform than another and therefore may force companies to change technologies (at considerable cost) or, at least, put them at a disadvantage to companies using “FDA-approved’ technologies. We feel that it would be preferable to allow for a reasonable degree of flexibility in data format and validation for PGx research activities."

Of course if such an approach is allowed we would lose the benefits of standardization of data format and validation. I think we can rely on the good ol' boys at the FDA to provide a certain degree of "flexibility". Now to be fair to J&J, they do also highlight some important issues:

"We routinely refer to the genes as being the biomarkers, yet, for DNA-based studies; it is the alleles that are the markers. Therefore, clarification would be required on the identity of the SNPs (and combinations thereof) which are considered to be “Known Valid Biomarkers” as well as the homozygous vs. heterozygous states that also have an impact on the outcome. This adds another level of complexity that should be clarified but should not be restricting."

Note that word "restricting". The important point is that it is the alleles (SNPs) that are the real biomarkers (informative markers if you will).