In the 7 December 2018 Federal Register, the US Food and Drug Administration (FDA) announced the availability of its new draft guidance document entitled "Developing and Labeling In Vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products." A link to the draft guidance document follows, (Developing and Labeling In Vitro)

Comments on the draft guidance are due by 5 February 2018.

The draft guidance document discusses factors relevant to the development and labeling, where appropriate, of companion diagnostics to support the indicated uses of a group or class of therapeutic cancer products, as opposed to just a specific product(s). It also discusses when such broader development and labeling may not be appropriate. According to FDA, the draft guidance document expands on existing Agency policy for broader labeling of companion diagnostics. Per existing policy, if evidence is sufficient to conclude that a companion diagnostic is appropriate for use with a specific group or class of therapeutic products, its intended use/indications for use can name the specific group or class rather than a specific product(s). FDA acknowledges that, in the past, trials designed to support approval of a specific therapeutic product and a specific companion diagnostic have led to narrower companion diagnostic labels that reference only a specific therapeutic product(s) as opposed to a product group or a class. Such narrow specificity in labeling can limit a potentially broader use of a companion diagnostic that may be scientifically appropriate, according to the Agency.

In addition to establishing a comment period for the draft guidance document, FDA is interested in feedback from interested parties on the following questions and issues:

  1. Please describe any specific challenges with developing the evidence needed to identify in labeling a companion diagnostic for use with a specific group or class of oncology therapeutic products, rather than a specific therapeutic product. For example, please describe any challenges resulting from industry or business practices, including business agreements. What actions can FDA take to address the challenge(s)?
  2. Please describe any specific challenges with submitting a premarket approval (PMA) supplement to FDA to expand the labeling for an approved companion diagnostic for use with a specific group or class of oncology therapeutic products. What actions can FDA take to address the challenge(s)?
  3. Please describe any additional actions FDA can take to facilitate or encourage broader, evidence-based labeling that supports the use of a specific group or class of oncology therapeutic products with a companion diagnostic.
  4. The guidance notes that variations in defined cut-points established for specific biomarkers for companion diagnostics can lead to challenges in implementing broader labeling for a specific group or class of oncology therapeutic products. Are there actions that FDA, or the broader scientific community, can take to facilitate standardization in this area?"

Commenting on the draft guidance document and supplying feedback on FDA's four additional questions/issues provides an important opportunity for developers of companion diagnostics to express their views to FDA on these topics and to influence FDA's ultimate thinking on the topics before Agency policy is established in a final guidance document. While one can always comment on a final guidance document, it historically is more impactful for firms to provide their views before finalization of a policy.

If you have any questions on the draft guidance document, on FDA's request for additional feedback or on companion diagnostics generally, please feel free to contact us.

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