What FDA’s Proposed Drug Testing Guidelines May Mean for You

July 15th, 2011
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This week, the FDA issued draft guidance for in vitro companion diagnostics. After a day or so of reflecting about it, here’s what I think it may mean for you:
Overall, while the guidance itself may not be BIG news, it does seem to make good sense for business and to offer life science companies some flexibility. Whether you are a therapeutics company or a diagnostics company, you should see new opportunities as a result.
Following are the key points I took away from my review of the guidance:


  • The FDA acknowledges that not all co-development of diagnostic tests and therapeutic drugs can occur simultaneously. Thus, there is room for you to secure approval of a drug before the test is available and also to seek to modify the drug’s label as new diagnostics information emerges. There is also room for you to potentially market an as yet uncleared or unapproved test, if the marketing of the test is critical in the context of a drug.
  • Every test that provides guidance about a treatment is NOT a “companion” diagnostic. For example, tests that predict a patient’s risk for adverse reactions to Warfarin are not companion tests. Instead, they are adjunct tests in clinical decision-making. This is an important distinction.
  • Put another way: Labeling really matters! A companion diagnostic would be labeled to indicate it is the determining factor in the safe and effective use of a drug. Keep this in mind as you plan your regulatory strategy.
  • Furthermore, drug labeling is likely to refer to a category of tests rather than to a specific branded test. Test labeling may reference a specific drug or drug class. Here again, this has implications for how you intend to market your companion diagnostic or targeted therapy.
  • FDA will allow submission of a test’s clinical validity data from the drug trial as the agency is keen to make the approval process efficient rather than requiring a separate study. This would obviously play into your clinical strategy in conjunction with your regulatory strategy.

So I see this approach as good news for my friends, colleagues and clients in the diagnostics and therapeutics industries. Clearly, the guidance shows a strong acknowledgement by the FDA of the growing role of diagnostic tests in targeted therapy. The agency appears to recognize that its facilitation of a smooth approval process is in the public’s best interest.
What are your thoughts about the guidance? Do you plan to submit comments? Are you willing to give us a sneak preview of your thoughts? We’d love to see them included below.

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About the Author:

I founded Popper and Company with Ken Walz more than ten years ago to address inefficiencies in health care by helping life science companies develop and commercialize new technology. Today, the members of our growing team leverage their extensive knowledge of the tools and trends shaping all aspects of health care and its participants. Send me an email.