ABSTRACT
How can risk be managed in a standardized drug distribution system, particularly when the risk is that babies might be born with severe congenital birth defects? The Food and Drug Administration (FDA) and the drug company Celgene faced this issue in the late 1990s when they intended to introduce the drug thalidomide to the US market. Currently, the drug is recognized as a promising treatment for a virtually endless list of conditions, including serious, life-threatening diseases such as AIDS wasting syndrome. But Thalidomide has a dark and dangerous past: it was promoted in the late 1950s as a sedative and treatment for morning sickness, before scientists and physicians discovered that it caused neurotoxicity among some patients, and devastating congenital malformations among babies born to women who took the drug. The problem with marketing thalidomide in the nineties is not just the drug's well-documented toxicity (many drugs on the market are as toxic, if not more so), but also its deep symbolic value. Thalidomide also played a key role in shaping US drug regulation. After thousands of babies were born with congenital malformations worldwide, and the disaster barely missed the US, a stringent drug regulation bill quickly became legislation. Thalidomide and the malformed babies symbolized the horror of unregulated drugs. With such a history, how could the FDA and Celgene introduce thalidomide to the North American market?
