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The One Day the FDA Finally Got It Right


On September 15, 2010, the FDA honored one of its most esteemed public servants with the first ever Kelsey award. The recipient was Dr. Frances Oldham Kelsey, now 96 years old, and for whom the award is named.

50 years ago, while working for the food and drug administration, Dr. Kelsey made a mighty stand on her very first assignment. She was given the task of reviewing a sleeping pill used in Europe, but the straightforward assignment soon took a momentous turn. Dr. Kelsey was uneasy about some of the possible dangerous side effects caused from repeated use of the drug best known as thalidomide. She refused to grant approval for its use in the United States, even though (not surprisingly) the drug manufacturers moved heaven and earth to override her decision.

As fortune would have it, it’s a good thing she held fast to her judgment. In 1961, stories of babies being born with serious birth defects began to emerge from European countries. The mothers of these babies took thalidomide while pregnant. As a result, approximately 4000 infants in Europe were born with tragic birth defects. Fortunately, American newborns averted this tragedy, thanks to Dr. Kelsey.

Constant scrutiny of the FDA continues on.

Nowadays, the FDA is under constant scrutiny regarding the amount of time it takes to test and approve drugs. It seems more times than not, the scrutiny is warranted. When you consider the number of drugs that have been recalled because of serious, and sometimes deadly, side effects it would appear that they are too quick to release drugs to an unsuspecting public. One reason for their haste is because of the unbelievable pressure put on them by pharmaceutical companies.

On the other hand, when you consider that there are nonconventional medications that have been proven to be effective in other countries, yet the FDA has yet to approve them, it seems that they’re moving at a tortoise pace.

It’s always best to err on the side of caution, however. If not for Dr.Kelsey’s insistence on taking the necessary steps before approving the use thalidomide, American children would have been born without limbs or with arms and legs that resembled flippers more than limbs. Such insistence on scientific protocol ensured thousands of families did not have to suffer as their European neighbors. Because of the thalidomide disaster Congress passed legislation that gave the FDA the authority to make sure drug manufacturers prove the safety and effectiveness of their drugs.

That should go down in history as the day the FDA got it right.

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