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The Four Guidances of the Apocalypse


The US Food and Drug Administration's recently released guidance on pharmacogenomic data submissions is an important step in the FDA's evolving ability to obtain, analyze, and, ultimately, approve pharmacogenomics data in drug discovery and development.

The guidance, whose release has been delayed several times since it was unveiled as a draft in November 2003, is actually one of four pharmacogenomics-related guidance documents that the FDA has in various stages of development.

The other three are:

  • The "Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping System", released March 9, and is essentially a roadmap for diagnostic companies to submit drug-metabolizing diagnostics to the FDA for clearance.
  • A draft guidance for the development of diagnostic-therapeutic companion products was originally due by the end of 2004, but has been delayed indefinitely. In the short term, the FDA said it has written a concept paper, which it will release in time for a Drug Information Association workshop April 11-13 in Bethesda, Md. The workshop, which will be sponsored by the FDA, the DIA, and members of the pharmaceutical industry, is designed to help the agency devise its "theranostic" guidance, Larry Lesko, director of the FDA's Office of Clinical Pharmacology and Biopharmaceuticals said during a conference call discussing the Pharmacogenomic Data Submissions guidance with reporters this week.
  • The third guidance "deals with microarray tests for DNA that is a very broad approach to genomic tests," Lesko said. "That is currently being revised following a period on the Internet"; there was a public docket for the guidance in April 2004, he added. Lesko did not say when a final version of that guidance is slated for release.

— CW

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