Merrell filed another application, and another, and another.

1 year ago
10.2K

Her FDA colleagues supported this decision. Merrell had expected a quick, affirmative reply so it could launch thalidomide for the holiday season, when sedative sales soar. Instead of supplying Kelsey with the data she requested they first tried to convince her to approve the drug over a series of calls and visits. When these failed to sway her, Merrell executives complained that stubborn and nit-picking Kelsey was the problem, not thalidomide. The FDA backed Kelsey, forcing Merrell to file another application, and another, and another.

Loading comments...