12:00 AM
Nov 07, 2011
 |  BioCentury  |  Regulation

Defying labels

Companion diagnostics debate: Drug labels will determine commercial opportunity

Comments on FDA's companion diagnostics draft guidance boil the debate down to who will have more control over which tests are used: companies or pathologists. If FDA requires inclusion of specific tests on labels, drug developers likely will be in the driver's seat. If the agency simply directs that tests provide certain kinds of data, it will be far easier for clinical laboratories to develop competitive tests.

When FDA issued its draft guidance in July, it was meant to facilitate the development and approval of drugs with companion diagnostics, as well as relieve companies of the burden of coordinating the agency's drug and device centers (see BioCentury, July 18).

When the public comment period ended last month, it became clear that sides were being drawn around one issue: how information about the tests should be included on the drug's label.

The guidance states that, when appropriate, the label should identify a type of FDA-approved or cleared test rather than a specific manufacturer's product.

Representatives from the drug and diagnostic industries - as well as some developers of laboratory-developed tests (LDTs) - would prefer the label contain the brand name of the test used during drug development, at least in the clinical trial section. They say the main reasons are to drive innovation and ensure patient safety.

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