Lilly Evista Overstatement of Benefits Cited By FDA For A Second Time
Executive Summary
Advertisements for Lilly's Evista overstate the benefits of the product while minimizing the possible risks, FDA declared in a Jan. 12 letter to the company.
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Lilly Evista subpoena
Subpoena from Department of Justice Consumer Litigation Office requests documents "generally related to the alleged marketing of Evista for uses not approved by the FDA," Lilly's quarterly report filed with SEC Aug. 14 says. The company received the grand jury subpoena in July. FDA reprimanded Lilly for marketing the osteoporosis drug for reduction in the risk of breast cancer and lowering cholesterol in 1998 and 1999 (1"The Pink Sheet" Jan. 25, 1999, p. 11). In 1999, Zeneca also received an injunction in federal court preventing the company from promoting Evista for breast cancer risk reduction (2"The Pink Sheet" July 26, 1999, p. 13). Lilly said it is cooperating with DoJ and believes its "policies and programs for promoting our products are lawful and proper." In addition, "we do not believe that the disposition of this matter will have a material adverse effect on our consolidated results of operations, liquidity, or financial position," Lilly said. PDI comarkets Evista with Lilly, but has yet to turn a profit with the product...