$515 Million Criminal Fine Is Largest Individual Corporate Criminal Fine in History; Civil Settlement up to $800 Million

American pharmaceutical giant Eli Lilly and Company today agreed to plead guilty and pay $1.415 billion for promoting its drug Zyprexa for uses not approved by the Food and Drug Administration (FDA), the Department of Justice announced today. This resolution includes a criminal fine of $515 million, the largest ever in a health care case, and the largest criminal fine for an individual corporation ever imposed in a United States criminal prosecution of any kind. Eli Lilly will also pay up to $800 million in a civil settlement with the federal government and the states. (more…)

Pharmaceuticals certainly have their place in health care. For example, drug therapy saves lives in cases of infections, certain cancers, and insulin-dependent diabetes, and it relieves suffering for those in acute and chronic pain. The fact is, we need pharmaceuticals for the proper treatment of a wide variety of illnesses. It is obvious, however, that we in the United States have put too much faith in drug therapy. (more…)

The FDA’s approval process for new prescription drugs is extensive. It can take over ten years for a drug to reach the market. Before receiving FDA approval, a new drug must be studied extensively. The process begins with the discovery or development of a new substance that can be used for medicinal purposes. The potential drug is first studied in a laboratory, then in animals. It is then studied in healthy adults to see what effects it produces and to determine how it works in the body. In the next phase of studies, the drug is given to a large number of people who are “sick, ” to see if the drug is effective.

If the drug passes through these rounds of testing, it is subjected to a thorough review by an FDA advisory committee, which determines from all of the information the company submits whether or not the drug works. Considerable emphasis is also put on the safety of this new drug. If the drug passes the FDA’s review, it can be put on the market. The result of this extensive review process is, ideally, a new, effective, safe drug that can help a person combat a disease (such as obesity) that can result in very serious outcomes.