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CDER s Woodcock: FDA To Publish Draft Guidance in August on Array Data in INDs


The Food and Drug Administration is planning to publish a draft regulatory guidance in August for how microarray-derived data can be used in the agency’s drug approval process, Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research, announced Tuesday at a one-day meeeting of the pharmacology and toxicology subcommittee of the advisory committee for pharmaceutical science.

“This is about getting innovative science to the bedside,” Woodcock said. “We need an approach that will enable the free exchange of information, [and] help advance the science and technology and the timely development of appropriate regulatory policies.”

Woodcock emphasized that genetic information is only a piece of the puzzle for improving drug safety and efficacy, but that it’s at the bottom of the pyramid. “If we can pull this off, we will move from an empirical process to a mechanism-based process that is hypothesis-driven, and have more effective, less toxic drugs for a smaller population. The potential is tremendous, but the question is just how soon [this potential will be met], and how many bumps in the road will there be?”

Tuesday’s meeting, held at the CDER’s Rockville, Md., offices. served as a backgrounder for the 13- member subcommittee. (See agenda at /ac/03/ agenda/3964A1_Draft.htm). The subcommittee, which is headed up by Meryl Karol, a professor of occupational and environmental health at the University of Pittsburgh, and which also includes John Quackenbush of the Institute for Genomic Research; representatives from Affymetrix and Agilent, as well as FDA employees, serves an advisory role and provides recommendations on FDA regulatory issues.

At the meeting, the committee was to consider three questions ( It planned to discuss comments about how proactive FDA CDER should be in enabling submissions of genomic technology data into non-clinical phases of drug development, and in clarifying how the results should be submitted; as well as the agency’s goals for the use of the data. Also, the subcommittee was to consider concerns about gene-expression data reproducibility across labs, platforms, and technologies, and the question of whether CDER should recommend one common data processing protocol and statistical analysis technique for each platform. Finally, the group was slated to consider whether the agency should develop an internal database to capture gene-expression and phenotypic outcome data from nonclinical studies to enhance its knowledge.

Tuesday’s meeting was to consider presentations of data around these questions, but not to answer them yet.

Regulation Riddles

Microarray analysis has made its way into the pharmaceutical and biotechnology industry’s R&D processes, and some say it is poised to become a significant factor in toxicology testing, as well as the future of personalized medicine. Thus far, however, regulatory agencies have yet to formulate a conceptual formulation for the regulation of this technology.

For the microarray industry, the question at the center of this discussion is how the FDA will formulate policy regarding the formatting, content, and submission guidelines for gene-expression data generated during non-clinical pharmacology and toxicology investigations.

Today, the FDA requires that any research done under an Investigational New Drug application be reported to the agency. So far, agency officials say very little data derived from microarray analysis has been submitted through this channel. And, agency officials say the data that has been submitted is not comparable, due to the multiplicity of platforms being used, and the methodologies of statistical analysis across the discipline.

The agency’s announced plan to release the draft guidance document in August is another preliminary step, to be followed by a comment period, a workshop, and then, finally, an actual guidance document. The document is to detail a process wherein genomic data derived from microarray analysis can be shared with and evaluated by the agency in a track outside the traditional drug approval process, creating a “safe harbor” for this data. This measure is to facilitate data collection from an industry that has adopted the tools of microarray analysis but is reticent about sharing its data with regulators without having some sort of assurance that it won’t be penalized as a result of any regulatory naiveté.

Lawrence Lesko, director of the agency’s office of clinical pharmacology and biopharmaceutics, told BioArray News (March 14, 2003) that such a safe harbor would help manufacturers use the technology in drug development, and share data with the agency so that it too could learn to evaluate microarray technology, and develop policies to guide its usage.



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