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Woodcock, Gutman Plan Theranostics Guidance; Seek to Marry Dx, Tx Data

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The head of the FDA’s Center for Drug Evaluation and Research and the director of the agency’s Office of In Vitro Diagnostics are currently co-writing a new draft guidance describing the use of jointly marketed diagnostic-therapeutic products, SNPtech Pharmacogenomics Reporter has learned.

This development, which follows the release of two related draft documents, is aimed at meeting head-on the rise of so-called theranostic products, and helping the agency further clear the regulatory path to pharmacogenomics.

CDER head Janet Woodcock and OIVD director Steven Gutman have been working on the new guidance for a short while, Woodcock said last week. She suggested it was the logical next step in the FDA’s expanding grasp of how pharmaceutical companies are using — or may soon use — pharmacogenomics technologies in drug-discovery and -development.

The new guidance will also become the latest stepping stone in the agency’s goal of regulating the collection and analysis of microarray data as an increasing number of drug makers begin using the technology more earnestly in their drug discovery and development research.

“We’re working closely with (OIVD on the composition of the draft molecular diagnostics guidance), and what we’re going to do is work on a joint (draft) on drug development and pharmacogenomics tests together,” Woodcock said.

She said the agency has not determined when the new draft might be released for comment, but said a final version might be ready in the fall. “We started … the process, but it’s going to be a while,” Woodcock said. “It’s going to be much simpler than” the pharmacogenomics draft guidance.

Woodcock said the new document will focus on “joint development” issues behind theranostic models. “We kind of promised it in [the November pharmacogenomics] draft,” she said. For example, the draft will seek to answer “‘What do you actually do if you are developing a test and a drug in parallel,’ and you want them to come out even at [the regulatory] end … [where] the drug label says, ‘Use this test,’” Woodcock said.

The FDA’s Center for Devices and Radiological Health, which oversees OIVD, would approve the test. “So we want to explain how that would work, what you should do, and what studies you should do ... so that people have a clear path,” Woodcock said.

She said the joint-development draft would be geared to theranostic pairings similar to Herceptin, but stressed that the immunohistology-based diagnostic used with this drug “will not be subject” to the suggestions in the new draft guidance. However, “any kind of pharmacogenomic diagnostic” will be allowed — including analyte-specific reagents, which rely on microarray technology — she said.

The FDA issued a draft guidance on the submission and use of pharmacogenomics data in November [see 11/6/03 SNPtech Pharmacogenomics Reporter], and a draft guidance on the use of certain molecular diagnostics tests in May [see 5/23/03 SNPtech Pharmacogenomics Reporter].

— KL

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