Publication Date: November 13, 2017
Industry: Pharmaceutical industry
Source: Harvard Business School
In the early 1960s, a popular drug taken by patients worldwide for a range of maladies was found to cause severe birth defects and other health problems in babies born to mothers who had taken it during a certain stage of fetal development. As many as 10,000 children may have been affected. Just a handful of these children were born in the U.S., where safety concerns were raised by Dr. Frances Oldham Kelsey, the medical officer handling the thalidomide application at the U.S. Food and Drug Administration. However, the company hoping to distribute the product in the U.S. had already given away thousands of pills for doctors to run clinical trials. Once the full extent of the global thalidomide crisis became generally known, the U.S. Congress significantly reformed the country's drug approval process, to ensure that all new products were both safe and effective. It subsequently became much more arduous for pharmaceutical firms to bring new drugs to market. Some critics therefore argued that the new regulations were actually detrimental, as they prevented or delayed good drugs from coming to market. What was the right balance between consumer protection and access to potentially life-saving drugs?