On Wednesday, July 14th, BIO submitted comments on FDA’s Guidances: 1) Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency Guidance; 2) Updated Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency: Questions and Answers; and the 3) Resiliency Roadmap for FDA Inspectional Oversight Report. In the updated Manufacturing, Supply Chain, and Inspections Questions & Answers document, BIO stated its appreciation for the clear statement in the Q&A Guidance that if a needed inspection cannot be completed due to travel restrictions but there are no other deficiencies (site/facility or otherwise in the application), FDA will defer action, rather than issuing a CRL. In terms of remote evaluations of bioresearch monitoring facilities, BIO proposed that many of the concepts introduced should be retained after the public health emergency ends and become another set of tools in FDA’s toolbox for inspectional activities, utilizing a risk-based approach. Furthermore, we emphasized that this approach could be used in the future to better distribute FDA resources for inspections, ensuring that the majority of staff time is focused on places where in-person assessment is truly needed, and information cannot be obtained via another method. Lastly, BIO requested additional detail regarding how FDA is utilizing the tools and robust dataset in its Resiliency Roadmap to address the inspectional backlog created by the COVID-19 public health emergency; how these tools fit into the larger inspectional paradigm; how remaining inspections will be prioritized; and estimates regarding the resolution of the current and additional backlog would be helpful.

We, the undersigned organizations, representing a broad and diverse group of the agriculture industry are pleased to support the consideration for Jenny Lester Moffitt, who currently serves as Undersecretary of the California Department of Food and Agriculture, to serve as Undersecretary for Marketing and Regulatory Programs at the U. S. Department of Agriculture. We greatly appreciate your efforts to directly engage our organizations, and our members as you work to develop policies that will have direct impact on our food and agriculture supply chain, and our consumers. This engagement has been vital to ensuring that the policies the administration pursues reflects the needs of our collective industries.

As you prepare for Chancellor Merkel’s visit to Washington, we, the representatives of America’s biotechnology sector thought that you and your government might benefit from an update on all that our sector is doing globally to address the ongoing COVID crisis, and in particular to ensure that patients in low-and middle-income countries get quick, safe access to COVID vaccines. The Biotechnology Innovation Organization (BIO) is the world’s largest biotechnology organization, with about 1000 members of all sizes, but most of whom are small and medium sized companies. BIO also has an extensive network of relationships with biotechnology associations around the world, including those in Germany.