Dr. Frances Oldham Kelsey, a long-time medical officer at the Food and Drug Administration (FDA), died recently. Her obituaries describe a long and distinguished career at the FDA but highlight her role in preventing the approval of the drug Thalidomide for use in the United States. When used by pregnant women, that drug caused fetal death or birth with serious deformities.
Unmentioned in the discussion of Dr. Kelsey’s successful effort to block use of Thalidomide in the U.S. is the role of the Department of State and the Foreign Service. In late October 1961, at the request of the Department of Health, Education, and Welfare (parent department of the FDA), the Department of State sent an instruction to the field “clarifying the responsibilities of the Food and Drug Administration and defining the type of information desired from foreign countries.” Among other things, it noted that the FDA was interested in the development of new and unusual foods and drugs and “[i]nformation on foods, drugs, devices, and cosmetics that have caused injury . . . .” Such reports were to be marked “Attention FDA” to ensure proper distribution.
Just one month later, the U.S. embassy in Bonn, West Germany, reported the withdrawal of four drugs containing Thalidomide because they allegedly caused deformities in children born to mothers who used them during pregnancy. The report also noted the establishment of a commission of experts to determine if there was a relationship between the drugs and the deformities.
In late December 1961, the Scientific Attaché in the embassy in Bonn submitted the following comprehensive and scientific report, written by Dr. Herman Chinn, the deputy Scientific Attaché.
According to a contemporary Department of State publication, Dr. Kelsey credited this despatch as a key document in her case against Thalidomide.
- Department of State Instruction GW-3697, October 26, 1961, file 411.0051/10-2661
- U.S. Embassy Bonn to Department of State, Despatch 722, November 29, 1961, file 411.0051/11-2961
- U.S. Embassy Bonn to Department of State, Despatch 857, December 22, 1961, file 862a.554/12-2261
All in 1960-63 Central Decimal Files (NAID 302021), RG 59: General Records of the Department of State.