We write to express our support for the nomination of Oregon Department of Agriculture Director Alexis Taylor to serve as the U.S. Department of Agriculture’s Under Secretary for Trade and Foreign Agricultural Affairs. U.S. agricultural producers and global food security will be well served through Director Taylor’s administration of the department’s trade promotion and capacity building programs—she is uniquely qualified for this role.

On Wednesday, June 22nd, BIO submitted comments on the FDA’s Quality Metrics (QM) Reporting Program. In the comments submitted, BIO stated appreciation for FDA’s intent to support a general shift toward a risk-based approach to regulation by bolstering its quality surveillance activities. However, BIO expressed the need for clarification around the program’s implementation to ensure it meets the Agency’s objectives without resulting in unintended consequences for both sponsors and regulators. In general, BIO pointed out significant variability in how metrics would be identified, defined, and reported. In addition to challenges posed by this variability, it is unclear how such data would be utilized by FDA. Thus, required reporting of lower-level metrics without contextual information associated with the data or trends could negatively impact sponsor operations and increase the potential for regulatory misinterpretation.