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FDA Opens Gate to Gene-Expression Data


The genomic-data firewall at the FDA is breaching.

“I am very positive, I think the FDA will use this data if it is guided correctly,” said Andrew Brooks, an assistant professor in the department of environmental medicine at the University of Rochester.

Brooks and four other members of the 14-person pharmacology and toxicology subcommittee joined nine FDA participants last week at a one-day meeting — the committee’s inaugural get-together — to consider issues surrounding the submission of microarray-based data in the agency’s drug-approval process (see SNPtech Reporter, June 13, 2003).

The subcommittee will create recommendations to hand up to the Advisory Committee for Pharmaceutical Science, which then will craft the guidance documents that will go through a comment period and industry workshops before being finalized to provide a framework for industry to follow.

The benefits will be: improved candidate drug selection; new sets of biomarkers for toxic response in animals and humans that minimize the need for animal studies; improved predictability for drug responders and side effects; and a rationalization for drug dosing based on a genetic substrate.

While Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research, said last week that the agency would have a draft guidance prepared by August, Brooks said that deadline might not be likely. He instead suggested that there will be rough ideas for guidelines that could be wrapped up within six months.

At the meeting, Brooks said the speakers were able to convince the FDA of the wisdom of collecting genomic data electronically.

“They heard from the community how they would have to be prepared, and what would they have to do,” Brooks said. Atop the list is the creation of a database for storing that information. The agency is involved in a pilot project with Schering-Plough and the Affymetrix platform-services provider Expression Analysis of Durham, NC, on a mock submission of microarray data. An initial submission is expected in July and a full mock submission coming in October.

“With [a database in place], the agency will start to expand their understanding of what the data provides and ... what high-throughput gene-expression profiling is telling,” said Brooks.



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