Genomics at FDA
Voluntary Genomics Data Submission (VGDS)

• Best Practices for Effective and Productive VGDS Meetings

About Voluntary Genomic Data Submissions

Voluntary Genomic Data Submissions (VGDSs) are a novel way to share information with the FDA.  At the current time, most pharmacogenomic data are of an exploratory or research nature and FDA regulations do not require that these data be submitted to an IND, or that complete reports be submitted to an NDA or BLA.  However, voluntary submissions can benefit both the industry and the FDA in a general way by providing a means for sponsors to ensure that regulatory scientists are familiar with and prepared to appropriately evaluate future genomic submissions. 

FDA and industry scientists alike would benefit from an enhanced understanding of relevant scientific issues, such as the following:

• The types of genetic loci or gene expression profiles being explored by the pharmaceutical industry for pharmacogenomic testing
• The test systems and techniques being employed
• The problems encountered in applying pharmacogenomic tests to drug development
• The ability to transmit, store, and process large amounts of complex pharmacogenomic data streams with retention of fidelity
• The scientific rationale for standardizing naming and characterization of the genes used on different genomic analysis platforms and for developing bioinformatics software programs used to evaluate pharmacogenomic data

 A greater understanding of the issues surrounding the use of pharmacogenomic data may prevent delays in reviews of future submissions where genomics are an integral part of specific studies in a drug development program.

 Therefore, the FDA is requesting that sponsors conducting such programs consider providing pharmacogenomic data to the Agency voluntarily, when such data are not otherwise required under the regulations.  To facilitate voluntary genomic data submissions (VGDSs), FDA has established a cross-center Interdisciplinary Pharmacogenomic Review Group (IPRG) to review VGDSs, to work on policy development, and, upon request, to advise review divisions on interpretation and evaluation of pharmacogenomic data. 

 For sponsors, voluntary submission of genomic data offers a number of specific potential benefits:

• It creates an opportunity for early informal meetings with FDA pharmacogenomics experts
• It offers flexibility in review and meeting process
• Sponsors receive and benefit from informal peer-review feedback on pharmacogenomic issues and/or questions
• Sponsors gain insight into current FDA thinking about pharmacogenomics that may assist in reaching important strategic decisions
• It offers time- and cost-savings by familiarizing both parties early with novel pharmacogenomic approaches avoiding future delays in review
• It provides an opportunity for sponsors to impact FDA’s thinking and help build consensus around future pharmacogenomic standards, policies and guidances

This process for voluntarily submitting genomic data to the FDA is further detailed in the document “Processing and Reviewing Voluntary Genomic Data Submissions (VGDSs),” MaPP 4180.3.

VGDS Process Flow

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Date created: March 22, 2005

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