September 16th, 2010
09:43 AM ET

FDA honors one of its own

You may not know her name and her face may not be familiar, but Dr. Frances Kelsey is a rock star to those at the Food Drug Administration where she worked some 50 years ago. Wednesday, she was honored by the Agency for her commitment and her courage.

In 1960 Kelsey’s first assignment was to review an application for a little known sedative being given to pregnant women in Europe for morning sickness. The drug, thalidomide, had already been approved in 20 other countries.

Despite pressure from the manufacturer, who even threatened a lawsuit, Kelsey refused to approve the thalidomide application, insisting they provide evidence of safety before the drug was approved here in the United States.

As that battle raged on, thalidomide was linked to severe birth defects when more than 10-thousand children worldwide we were born limbless or with flipper-like arms and legs.

"Thousands of American Children were spared that fate because Frances Kelsey was steadfast in her determination that it would not happen here," said Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research at FDA. "In every possible way, she’s been a game changer. Her actions helped transform the FDA and drug regulation."

In fact, because of Kelsey’s perseverance, legislation that would give the FDA new authority but was stalled in Congress actually passed. In 1962, amendments to the Food, Drug & Cosmetic Act mandated clinical trials, implemented informed consent, and gave the FDA access to all study data.

That same year, President John F. Kennedy gave Kelsey the President’s Award for Distinguished Federal Civilian Service. She was the second woman to ever get that award.

The March of Dimes notes that "Dr. Kelsey often is credited with sealing the FDA's reputation as the world's premier authority on food and drug safety."

Kelsey, who is now 96 years old, is the first FDA employee to receive the honor she received Wednesday. Now, ach year, the FDA will select a staff member to receive the "Dr. Frances O. Kelsey Award for Excellence and Courage in Protecting Public Health."

soundoff (64 Responses)
  1. Ingrid F. RN.NP

    My congratulations to Dr.Kelsey, for her brilliant decision and abilty to convince the power structure to go along with her recommendations, to ban thalidomide in the US.
    I was a young nurse on a maternity unit in the early 60s in Germany, witnessing the first babies with Thalidomide (Contergan in German) defects being born, some were stillborn. We all were stunned, no word at the time what the cause might be.Then came the day when the medication cabinets in hospitals and pharmacies had to be emptied of thalidomide, as per Government order. Production was halted.
    The headlines in major news outlets soon followed, as well as lawsuits for years. The German Government and the Pharmacutical company paid for years, perhaps to this day, for disability benefits, adaptive equipment and the education for these individuals. One brilliant star out of this is the classical lieder singer, Thomas Quest, often performing in the US.
    My point today is: we must remain vigilant to this day and not approve medications before they have been well tested, by the time they come to market. Too many near disasters have already occurred during the last decade. And please stop big pharma's direct to consumer advertising, we need another legislative act.

    September 16, 2010 at 12:28 | Report abuse | Reply
  2. George Berry

    THIS IS ABSURD! Frances Kelsey withheld approval of thalidomide because she was waiting for additional data that is caused perirpheral neuritis or "pins and needles". It had absolutely nothing to do with birth defects. It was merely the foot dragging of a dyed in the wool bureaucrat. But, nevertheless, Pres. Kennedy recoginized the opportunity.

    The real "hero" of identifying and stopping the thalidomide tragedy was Dr. Widikund Lenz of Germany. His use of "descriptive epidemiology" spared the world of further tragedy.

    September 16, 2010 at 12:46 | Report abuse | Reply
    • Kathy

      Sounds like you do not like it because a woman did this. Well get use to it because now that women are being givena fair chance at everything, women will be leaving you males in the dust in almost every area.

      September 19, 2010 at 03:08 | Report abuse |
    • Mark K .

      Nice thanks for the info – somehow that was overlooked in the post

      September 19, 2010 at 12:16 | Report abuse |
  3. AntiFDA

    Maybe we should give all government employees an award for simply doing their job. I am in a business sector that deals constantly with the FDA, and I have found them to be one of the most inept departments of government. Everyone at the FDA is so scared to be on the hook for any type of decision that they simply either deny everything, or make the process so painstaking that only the corporate giants can afford to satisfy their demands. I firmly believe the the FDA has harmed or killed more people that it has helped. There are several drug candidates out there that can offer years of extended life or even cure some of the sickest patients, but they are all stalled in the bureaucracy of the FDA approval process. I am talking about drugs for people who have reached the end of the line with conventional medicine, and have no other choice but death. I know we all will pass someday, but if there is an experimental remedy out there, why not let the patient have that opportunity, instead of having to die cause some washington "doctor" says he needs more time to read the studies. Dr. Margeret Hamburg is a complete joke, just like her boss is.

    September 16, 2010 at 13:56 | Report abuse | Reply
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      while i to hope this would be the case, i dont think they will improve much

      September 19, 2010 at 12:17 | Report abuse |
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