Frances Oldham Kelsey Vs Robert F. Kennedy, Jr
Frances Oldham Kelsey was a Canadian American pharmacologist & physician. As a reviewer for the U.S. Food and Drug Administration (FDA), she refused to authorize thalidomide for market because she had concerns about the lack of evidence regarding the drug's safety.
One of her first assignments at the FDA was to review an application by Richardson-Merrell for the drug thalidomide (under the tradename Kevadon) as a tranquilizer and painkiller with specific indications to prescribe the drug to pregnant women for morning sickness. Of the seven reviewers whose signatures were required for approval, she was the only one who questioned the inadequacy of the incomplete safety data submitted by the manufacturer.
Back then, a reviewer could delay approval by requiring additional information for 60 days (if at the end of sixty days no new questions were raised then the candidate medication was automatically approved). She repeatedly submitted new questions about the safety and clinical trials of thalidomide when each 60 day period ended.
She was able to delay approval until her insistence that the drug should be fully tested prior to approval was vindicated in November 1961 when the births of deformed infants in Europe were linked to thalidomide ingestion by their mothers during pregnancy.
Kelsey was awarded the President's Award for Distinguished Federal Civilian Service by John F. Kennedy on August 7, 1962 for her persistence.
Fast forward to 2025. John F. Kennedy’s nephew, Robert F. Kennedy, Jr. has crippled the Public Health Services in America, slashed federal funding of life saving medical researched, fired world renowned scientists and physicians and replaced them with charlatans molded in his own incompetent and dangerous image.
It’s not too late, America. Demand his resignation and replacement with a qualified medical professional to lead the Department of Health and Human Services, reverse his atrocious policies and decisions and get Public Health and medical research in America back on track!
One of her first assignments at the FDA was to review an application by Richardson-Merrell for the drug thalidomide (under the tradename Kevadon) as a tranquilizer and painkiller with specific indications to prescribe the drug to pregnant women for morning sickness. Of the seven reviewers whose signatures were required for approval, she was the only one who questioned the inadequacy of the incomplete safety data submitted by the manufacturer.
Back then, a reviewer could delay approval by requiring additional information for 60 days (if at the end of sixty days no new questions were raised then the candidate medication was automatically approved). She repeatedly submitted new questions about the safety and clinical trials of thalidomide when each 60 day period ended.
She was able to delay approval until her insistence that the drug should be fully tested prior to approval was vindicated in November 1961 when the births of deformed infants in Europe were linked to thalidomide ingestion by their mothers during pregnancy.
Kelsey was awarded the President's Award for Distinguished Federal Civilian Service by John F. Kennedy on August 7, 1962 for her persistence.
Fast forward to 2025. John F. Kennedy’s nephew, Robert F. Kennedy, Jr. has crippled the Public Health Services in America, slashed federal funding of life saving medical researched, fired world renowned scientists and physicians and replaced them with charlatans molded in his own incompetent and dangerous image.
It’s not too late, America. Demand his resignation and replacement with a qualified medical professional to lead the Department of Health and Human Services, reverse his atrocious policies and decisions and get Public Health and medical research in America back on track!
