CASE $3\mathrm{.}1-$Selling Off$-$Label

In the pharmaceutical industry, off$-$label marketing involves selling prescription drugs for purposes and conditions that are not identified on the FDA$-$approved label and accompanying specifications. In other words, a drug that has been approved and tested for efficacy and safety for specific uses may be often marketed and prescribed for purposes that have not been deemed safe. Accordingly, selling drugs off$-$label violates relevant ethical codes for the industry and is considered a criminal offense.

Over the past several decades, pharmaceutical companies have been found in violation of such laws and codes. In recent years, several major companies$-$Johnson & Johnson, AstraZeneca, Eli Lilly & Co$.,$ and Pfizer$-$have paid enormous fines and been subjected to other penalties for such violations. ${?}^{34}$ Since $2004,$ Lilly, Bristol$-$Meyers Squibb, and four other companies have paid $$7$ billion in fines and penalties. Most spectacularly, Pfizer alone paid $$2\mathrm{.}9$ billion in penalties and settlements in $2009$ for this practice. ${?}^{35}$ Despite the sanctions,