The U.S. FDA is set to honor Dr. Frances Kelsey, a former medical reviewer who helped start the modern era of clinical trials 50 years ago. Dr. Kelsey prevented the approval of thalidomide in the United States because of concerns about peripheral neuropathy and the lack of testing on the drug’s safety. Among the drug’s proposed usages included treating morning sickness during pregnancy. It was unknown at the time that the drug would pass the placental barrier between a pregnant woman and the fetus. In Europe there were thousands of “thalidomide babies” born with terrible birth defects, including phocomelia, that left the children with deformed limbs sometimes resembling a seal type flipper instead of an arm or leg. The tragedy led to the Kefauver-Harris Amendments to the Food Drug and Cosmetic Act and the requirement for “adequate and well controlled trials” along with testing for safety.
FDA Commissioner Dr. Margaret Hamburg announced that FDA would honor Dr. Kelsey’s achievements.
“50 years ago a relatively junior medical reviewer, Dr. Frances O. Kelsey said no to an application to market the drug thalidomide. Despite what she called un-relenting pressure from the manufacturer, she remained unconvinced of the drug’s safety especially its potential effects on the unborn.
Dr. Kelsey’s decision has been described as a game changer for the Agency and the country. Her action spared untold numbers of children in the United States from devastating birth defects caused by the drug and spurred the passage of legislation that gave the FDA authorities it needed to better protect the public health; setting it on a course to become the nation’s premier public health agency that it is today.
On Wednesday September 15th at 10:30 AM I will present a new Commissioner’s award, The Dr. France O. Kelsey Award for Excellence and Courage in Protecting the Public Health, to its first recipient, Dr. Kelsey herself. This award will be given on a regular basis by the FDA Commissioner to selected FDA employees.”
Congratulations to Dr. Kelsey. She certainly deserves the honor.
UPDATE: NY Times article on the event
Read Dr. Kelsey’s Bio from Chemistry Explained. It tells how she and her husband were among the first scientists to verify that some drugs that are safe for adults are dangerous to human embryos. Very interesting reading.
Save The Date: On 4-5 November 2010 the Pacific Regional Chapter of the Society for Quality Assurance (PRCSQA) and the Organization of Regulatory and Clinical Associates (ORCA), a Pacific Northwest based organization, will co-sponsor a Fall Training on regulatory compliance topics in Seattle, WA.
The PRCSQA LinkedIn Group will update the agenda for the training. PRCSQA Fall Training workshops have traditionally been “at cost” and are an affordable training opportunity. The sessions will cover both GCPs and GLPs with speakers lined up on vendor management, quality systems, and GLP updates.
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Read the updated article on the Form FDA 1572 in:
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