All Zika, All the Time II
Good News: The new Zika guidance is as clear as can be. Bad News: Universal ID-NAT is a titanic operational effort-unclear it can be finished on the FDA's schedule. Good News: A universal mandate becomes a pass through that attenuates concerns about its cost-the end user (hospitals) will (appropriately) bear it. Bad News: Might the $100 million* we will consume in the next year be put to better use, e.g., mosquito control? Many of us are asking if this is the best use of public health resources.
My list could be longer, but…
First message: "Just Do It." The blood community, and ABC's specifically, is committed to safety and pursuit of regulatory compliance.
Second message: The opaque process leading to the guidance, with its timelines, is not acceptable. The FDA is responsible for a lack of transparency and stakeholder engagement since the spring, and we are for not using validated crystal balls.
The agency is on committees with the blood community, but there was never a meaningful discussion of universal ID-NAT's feasibility. I thought we were receiving clear signals the revised guidance would mandate testing across a wide swath of southern states, where the risk of mosquito transmission is concentrated. Assuming existing labs have the space and warm bodies required, and test vendors can deliver instruments, service, and reagents (huge assumptions), and had we been able to read our tea leaves with greater prescience, our preparation for (1) installation of investigational testing equipment and software, (2) training, (3) platform, assay, and operator qualification, (4) validation, and (5) implementation, our early, transparent engagement would have yielded longer timelines. The outcome would be a higher chance of success without delays and lower risk of cGMP mishaps-both for Zika testing and other safety activities.
Over the last six to eight weeks, many of my inquiries about details in the guidance were answered with, "we cannot talk about the details of guidance once we start writing." I have tried to dig into FDA'sGood Guidance Practicesand CFR to understand if this is true. 21 CFR 10.80(d)(1) states, "Details of a draft of a final notice or regulation may be discussed with an interested person outside the executive branch only with the specific permission of the Commissioner." I cannot figure out if this language applies or not, but it should. I wonder if this kind of an approach isn't the roadmap to more orderly promulgation of even urgent guidances. Inquiries are in progress.
Our interest is not an appeal about the content of the guidance. It is an appeal to regulators to appreciate our constraints around complex interventions in the face of the intricate processes involved-reasonable timelines being the "bottom line" in this instance.
* "Back of the envelope" cost recovery" at ≈$7-8/reported result in the next 12 months.
Louis Katz, MD; Chief Medical Officer