Eli Lilly and Company has agreed to plead guilty and pay $36 million in connection with its illegal promotion of its drug Evista. The Justice Department said the company is pleading guilty to a criminal count of violating the Food, Drug, and Cosmetic Act by misbranding the drug.
Lilly will pay a $6 million criminal fine and forfeit to the United States an additional sum of $6 million. In addition to the criminal plea, Lilly has agreed to settle civil Food, Drug, and Cosmetic Act liabilities by entering into a consent decree of permanent injunction and paying the United States $24 million in equitable disgorgement.
At issue is Lillys marketing of Evista, which was approved by the FDA for prevention and treatment of osteoporosis.
The FDA charges that Evista sales were so disappointing its first year on the market, Lilly starting promoting the drug for unapproved uses -- which is illegal. Once approved by the FDA, the drug may not be legally marketed or promoted for so-called off-label uses - any use not specified in an application and approved by the FDA.
In October of 1998, the company reduced the forecast of Evistas first years sales in the U.S. from $401 million to $120 million, prosecutors said. An internal Lilly business plan noted a disappointing year versus original forecast. The information filed with the court alleges that Lillys strategic marketing plans and promotion touted Evista as effective in preventing and reducing the risk of diseases for which the drugs labeling lacked adequate directions for use.
According to the information, Lillys Evista brand team and sales representatives promoted Evista for the prevention and reduction in risk of breast cancer, and the reduction in the risk of cardiovascular disease.
Under the provisions of the Food, Drug, and Cosmetic Act, Evista was misbranded when its labeling did not bear adequate directions for each of these intended uses. As alleged in the information, Lilly promoted Evista as effective for reducing the risk of breast cancer, even after Lillys proposed labeling for this use was specifically rejected by the FDA.
The agency maintains that potential problems that can arise from off-label use without the benefit of careful FDA oversight include the possibility that the promoted drug was used instead of another drug that had already been approved by the FDA for a particular use.
The information alleges that Lilly executed its illegal conduct using a number of tactics, including:
• One-on-one sales pitches by sales representatives promoting Evista to physicians about off-label uses of Evista. Sales representatives were trained to prompt or bait questions by doctors in order to promote Evista for unapproved uses;
• Encouraging sales representatives promoting Evista to send unsolicited medical letters to promote the drug for an unapproved use to doctors on their sales routes;
• Organizing a market research summit during which Evista was discussed with physicians for unapproved uses, including reducing the risk of breast cancer; and
• Creating and distributing to sales representatives an Evista Best Practices videotape, in which a sales representative states that Evista truly is the best drug for the prevention of all these diseases referring to osteoporosis, breast cancer, and cardiovascular disease.
The complaint for permanent injunction alleges that Lilly executed its illegal conduct using a number of additional tactics, including:
• Training sales representatives to promote Evista for the prevention and reduction in the risk of breast cancer by use of a medical reprint in a way that highlighted key results of Evista and thereby promoted Evista to doctors for an unapproved use. The complaint says some sales representatives were instructed to hide the disclosure page of the reprint which noted, among other things, that All of the authors were either employees or paid consultants of Eli Lilly at the time this article was written, and The prescribing information provides that The effectiveness of [Evista] in reducing the risk of breast cancer has not yet been established.;
• Organizing consultant meetings for physicians who prescribed Evista during which unapproved uses of Evista were discussed; and
• Calculating the incremental new prescriptions for doctors who attended Evista advisory board meetings in 1998. The advisory board meetings included discussion of unapproved uses for Evista. By measuring and analyzing incremental new prescriptions for doctors who attended the advisory board meetings, Lilly was using this intervention as a tool to promote and sell Evista.