FDA seems to take light approach to Allergan and Lap-Band

In 1960, a young inspector for the Food and Drug Administration faced down a powerful drug company by rejecting its application to sell a morning-sickness drug in the United States.

The company, Richardson-Merrell, griped about her repeated demands for more safety data. They complained to her superiors, branding her as a nitpicker. But she stood firm.

The drug in question was thalidomide, and worldwide as many as 12,000 children were born with severe birth defects after their mothers used it. In the U.S., where Frances Oldham Kelsey blocked Merrell from distributing the drug except to a few doctors for “experimental” trials, the toll was 17. Thanks to her, the FDA gained a reputation as a vigilant watchdog.

Today’s FDA isn’t that FDA.

Read the rest of the commentary here.

Print Print  

Leave a comment