Overview - Office of International Programs
Dr. Murray Lumpkin is Deputy Commissioner for International Programs, and Mary Lou Valdez, is Associate Commissioner. The Office of International Programs (OIP) consists of the following offices: Africa and Asia, China, Europe, Harmonization and Multilateral Relations, India, Latin America, Middle East, and the Quadrilateral and Trilateral.
OIP is the Agency focal point for all international issues. In this role, OIP manages and coordinates international activities with the primary purpose of gathering and assessing information in the international arena that will enable FDA centers and inspectorate to make better decisions regarding the quality, safety, and effectiveness of products destined for the US market. OIP strives to effect an affirmative public health agenda in the international arena; to enhance and maximize the impact of FDA’s communications and interactions globally; to help assure they reflect the Agency’s policies and best scientific, legal, and policy thinking; to help assure that FDA international communications and interactions are consistent with HHS and administration public health objectives; and to leverage more effectively the human, financial, and informational resources of other trusted counterpart agencies and U.S. Government counterpart agencies with complementary missions in meeting the FDA’s public health mission.
OIP is responsible for, but not limited to, the following activities:
- communicating with foreign governments and international organizations, including foreign embassies and consulates in the United States;
- exchanging better and more robust information from countries to enable FDA officials in the centers and at our borders to make better decisions about FDA-regulated products that are being developed for the U.S. market, that are being reviewed for marketing authorization in the U.S., that are being presented for entry into the U.S., and that are currently on the U.S. market;
- working with the regulated industries that wish to export their products to the U.S. to help assure their understanding of our standards and expectations regarding FDA-regulated products;
- assessing, in real-time and in-country, conditions and events in those areas that might have an impact on the safety, quality, and availability of FDA-regulated products exported to the U.S.;
- engaging more proactively and consistently with various communities in strategic regions abroad -- foreign governments, foreign regulatory counterparts, industry, academia/research community -- to help FDA better accomplish its domestic mission to promote and protect the public health of the U.S.;
- managing formal arrangements with foreign governments, e.g., memoranda of understanding, mutual recognition agreements, exchange of letters, partnerships, equivalence issues, country assessments, and confidentiality commitments;
- facilitating international technical cooperation and assistance activities and capacity building across the Agency;
- implementing policies and procedures pertaining to international travel, passports and visas, and processing international travel requests; and (9) coordinating the FDA international visitors program.
OIP Contact Information:
Tel: (301) 827-4480