CONGRESSIONAL OVERSIGHT PROCESS FULL

We will also describe some potential enhancements that would enable FDA to complement our foreign drug inspection program. These standards are known as current good manufacturing practices (CGMPs). We will also explain our approach when our inspections indicate that a facility does not operate in keeping with established quality standards. Today we will provide the Committee with an overview of the history of FDA’s foreign drug inspection program, and the ways it has evolved in response to the industry’s globalization and changes in law and regulation.

CONGRESSIONAL OVERSIGHT PROCESS FULL

We want to assure the American public that we have full confidence in the safety and quality of the products we all use every day and that the FDA will continue to leverage all available authorities to continue to ensure the integrity of the products we regulate. This can include, among other things, evaluating records in advance of or in lieu of conducting an onsite inspection when travel is not permissible, when appropriate. Importantly, during this interim period we’re evaluating additional ways to conduct our inspectional work that would not jeopardize public safety and protect both the firms and the FDA staff. Mission critical inspections are identified on a case-by-case basis and conducted with appropriate safety measures in place. This will continue as conditions warrant, with the exception of certain mission critical inspections, including pre-approval and for-cause assignments. When FDA identifies significant manufacturing or safety issues, it quickly acts to protect Americans.ĭuring the COVID-19 pandemic, FDA is continuing to utilize and implement additional alternative inspection tools and approaches while postponing foreign and domestic routine surveillance facility inspections. This testing has consistently shown that medicines manufactured in foreign countries that are imported into the United States meet U.S. FDA laboratories test for drug quality, using testing standards set by the United States Pharmacopeia, or standards submitted in marketing applications, or methods developed by FDA. The Agency inspects drug manufacturing facilities located around the world with comparable depth and rigor based on an assessment of risk to public health. FDA thoroughly reviews drug applications to ensure that medications are safe and effective before they reach the market and oversees drug quality post-approval. drug supply is among the safest in the world. United States Senate Committee on FinanceĬhairman Grassley, Ranking Member Wyden, and Members of the Committee, thank you for the opportunity to testify today on a matter of the utmost importance to the Agency: protecting the safety, quality, and availability of medicines for Americans.

Congressional oversight process