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FDA to Update PGx Guidance to Address Technical Issues; Seeks Industry Comment on Draft Recommendations

WASHINGTON (GenomeWeb News) – The US Food and Drug Administration is planning to update its pharmacogenomics guidance to address a number of technical questions that the original document, released in 2005, left unanswered, FDA officials said today.
Speaking at a workshop here, Federico Goodsaid, senior staff scientist in the genomics group at FDA’s Office of Clinical Pharmacology, said that the agency plans to release an “attachment” for the pharmacogenomics guidance document in about a year that will provide recommendations on a number of technical issues, such as sample preparation, labeling systems, hybridization protocols, and reporting formats.
The two-day workshop, “Best Practices and Development of Standards for the Submission of Genomic Data to the FDA,” was co-sponsored by the FDA, the Drug Information Association, the Pharmaceutical Research and Manufacturers of America, and the Biotechnology Industry Organization in order to identify key issues that the upcoming guidance attachment should address.
Goodsaid noted that the FDA has so far reviewed around 30 submissions under its 2-year-old voluntary genomic data submissions initiative. While VGDS has been “helpful” for the FDA’s understanding of genomics data, he said, it has also highlighted “the need for consensus in a field that is constantly changing.”
“There are several steps in generating gene expression signatures,” he said, “and each can be conducted in more than one way.”
Goodsaid explained that the VGDS submissions have “helped us understand areas where consensus is available,” and have also highlighted a number of areas — such as algorithms and statistical methods for analyzing microarray data — where there is little or no agreement in the community.
As a first step toward building broader consensus in the field, the FDA has released a draft “concept paper” that outlines a number of recommendations in areas where there is some degree of agreement. The concept paper, “Recommendations for the Submission and Review of Genomic Data,” addresses four main topics: gene expression microarray data, genotyping, genomic data in clinical study reports, and genomic data from nonclinical toxicology studies.
Goodsaid told GenomeWeb News that the agency plans to gather feedback on the draft concept paper from workshop attendees and the broader community over the next year and that it will take that input into consideration for the final attachment to the pharmacogenomics guidance.
Another goal of this week’s workshop, he said, is to spur discussions around some more controversial issues — such as algorithms, statistical methods, and specific data standards — that were considered too unsettled to be included in the draft concept paper.
Goodsaid said that those issues could eventually be addressed in a separate concept paper or attachment, but that will largely depend on the outcome of the workshop. “We’re getting there,” he said. “Sometimes asking questions is the first step in building consensus.”

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