Bradley Merrill Thompson Quoted in Article, “FDA Releases Guidance on Companion Diagnostics”

IVD Technology

Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled, "FDA Releases Guidance on Companion Diagnostics."

Following is an excerpt:

FDA released its draft guidance on in vitro companion diagnostic devices. The guidance is intended to assist companies that are planning to develop a drug that depends on the use of a companion diagnostic for its safe and effective use as well as those companies that are planning to develop a companion diagnostic that is intended to be used with a corresponding drug.

"I generally like this guidance document as far as it goes," said Thompson. "It represents a positive evolution in FDA's thinking, in which theory is starting to meet reality. The agency has tried to acknowledge that co-development of therapeutic drugs and diagnostic devices proceeds in lots of different ways, often far from the theoretical and idealized approach of lockstep development. ...

"The problem is that the document is thin," said Thompson. "Influenced no doubt by the sheer complexity of the number of possible scenarios for co-development, FDA chose to stay at a very high principled level. The agency really doesn't get its hands dirty dealing with the more nitty-gritty regulatory questions. The problem is that's where the challenges are. ...

"I know that a number of companies have expressed specific questions to the agency to deal with the more tactical issues. While FDA can't address everything, it seems to me the agency ought to spend a little more time trying to address the questions that they are hearing most often at a granular level. Such topics might include the following: the use of bridging or concordance studies to link clinical data with older versions of an assay used in previous clinical studies; specific regulatory pathways for specific scenarios (i.e., When is a PMA required instead of premarket notification?); and details around the type of analytical study package necessary to support clinical testing of an IVD."