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In the 1960s thalidomide, a popular new drug considered to be safe and effective, was revealed to cause severe nerve damage and birth defects in newborn infants, prompting health officials to ban the use of the drug and tighten overall restrictions on new drugs and drug use. Twenty years later, after recognizing the positive effects of thalidomide when treating patients with leprosy and its potential role in the treatment of certain types of cancer and cases of HIV/AIDS, the Celgene corporation would be forced to contend with stringent FDA regulations, liability concerns, public skepticism, and poor mass media portrayal in order to secure the drug's approval.

To illustrate how regulators are subject to political pressure, which companies much recognize and consider when making business decisions.