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Dr. Kelsey, Pioneer of FDA Drug Trials, Dies at 101

Dr. Frances Oldham Kelsey, a Canadian pharmacologist instrumental in preventing birth injuries from medications, died on August 7 at the age of 101. Dr. Kelsey’s passing is notable because of her lifetime of work protecting the public from dangerous drugs and medications. Her most notable accomplishment led to the ban of thalidomide in the U.S.

Dr. Stephen Ostroff, acting commissioner of the US Food and Drug Administration, said of her passing, “Our nation lost a true pioneer in public health and consumer protection.” Because of her efforts, countless birth defects were prevented and the United States passed legislation that gave rise to the modern regulatory practices of the FDA.

Her history with the FDA

Dr. Kelsey began working for the FDA in 1960; one of her first assignments was to review an application to allow Richardson-Merrill to sell thalidomide, a tranquilizer and painkiller intended to reduce morning sickness in pregnant woman, in the United States. Despite its popularity in other countries and pressure from the company to approve the drug, Dr. Kelsey insisted further research was necessary.

Her efforts led to the discovery that thalidomide dramatically affected a fetus and caused serious birth defects. Children of mothers who took thalidomide during pregnancy were born without limbs and sometimes did not survive birth. At her insistence, thalidomide was never approved for sale in the United States.

John F. Kennedy presented Dr. Kelsey with a President’s Award for Distinguished Federal Civilian Service in 1962. In 2000, she was inducted into the National Women’s Hall of Fame. Dr. Kelsey retired in 2005 after 45 years in the service of public health. Because of her work, an entire generation was spared the emotional anguish and lifelong suffering that thalidomide caused in other countries.

Today, the FDA’s drug-approval process is far more stringent and complex than it was in 1960. This is due, in part, to Dr. Kelsey’s efforts and her insistence that the public be protected whatever the cost:

“Her efforts on thalidomide fueled the passage of legislation giving the FDA greater oversight and regulation of pharmaceutical products, requiring drug companies to conduct phased clinical trials to demonstrate efficacy of a new drug, in addition to safety, obtain informed consent from participants, and report side effects to the FDA. The regulations also gave the FDA greater control over drug advertising.”

While the procedures are still imperfect, they have protected countless lives and prevented needless suffering.

Dr. Ostroff said, “Our nation owes a great debt of gratitude to Dr. Frances Oldham Kelsey for her decades of service to public health.” We at Crandall & Pera Law would like to add our own thanks to Dr. Kelsey. Without her, untold numbers of children would never have had a chance at life, and countless more would be at risk without the protections afforded by the FDA.  While the struggle continues to refine the system, mistakes can be made; if you or someone you know has suffered because of a faulty medication or medical device, please contact us today to schedule an appointment in one of our Ohio or Kentucky offices.

Dr. Frances Oldham Kelsey, a Canadian pharmacologist instrumental in preventing birth injuries from medications, died on August 7 at the age of 101. Dr. Kelsey’s passing is notable because of her lifetime of work protecting the public from dangerous drugs and medications. Her most notable accomplishment led to the ban of thalidomide in the U.S.

Dr. Stephen Ostroff, acting commissioner of the US Food and Drug Administration, said of her passing, “Our nation lost a true pioneer in public health and consumer protection.” Because of her efforts, countless birth defects were prevented and the United States passed legislation that gave rise to the modern regulatory practices of the FDA.

Her history with the FDA

Dr. Kelsey began working for the FDA in 1960; one of her first assignments was to review an application to allow Richardson-Merrill to sell thalidomide, a tranquilizer and painkiller intended to reduce morning sickness in pregnant woman, in the United States. Despite its popularity in other countries and pressure from the company to approve the drug, Dr. Kelsey insisted further research was necessary.

Her efforts led to the discovery that thalidomide dramatically affected a fetus and caused serious birth defects. Children of mothers who took thalidomide during pregnancy were born without limbs and sometimes did not survive birth. At her insistence, thalidomide was never approved for sale in the United States.

John F. Kennedy presented Dr. Kelsey with a President’s Award for Distinguished Federal Civilian Service in 1962. In 2000, she was inducted into the National Women’s Hall of Fame. Dr. Kelsey retired in 2005 after 45 years in the service of public health. Because of her work, an entire generation was spared the emotional anguish and lifelong suffering that thalidomide caused in other countries.

Today, the FDA’s drug-approval process is far more stringent and complex than it was in 1960. This is due, in part, to Dr. Kelsey’s efforts and her insistence that the public be protected whatever the cost:

“Her efforts on thalidomide fueled the passage of legislation giving the FDA greater oversight and regulation of pharmaceutical products, requiring drug companies to conduct phased clinical trials to demonstrate efficacy of a new drug, in addition to safety, obtain informed consent from participants, and report side effects to the FDA. The regulations also gave the FDA greater control over drug advertising.”

While the procedures are still imperfect, they have protected countless lives and prevented needless suffering.

Dr. Ostroff said, “Our nation owes a great debt of gratitude to Dr. Frances Oldham Kelsey for her decades of service to public health.” We at Crandall & Pera Law would like to add our own thanks to Dr. Kelsey. Without her, untold numbers of children would never have had a chance at life, and countless more would be at risk without the protections afforded by the FDA.  While the struggle continues to refine the system, mistakes can be made; if you or someone you know has suffered because of a faulty medication or medical device, please contact us today to schedule an appointment in one of our Ohio or Kentucky offices.

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