• On September 29, California Governor Arnold Schwarzenegger signed into law a bill (S.B. 1765) that requires pharmaceutical companies that do business in California to adhere to the OIG guidance and PhRMA Code. Among the requirements is that pharma companies doing business in California develop a compliance program and detail the amount of promotional money they'll spend on physicians annually. The deadline: July 1, 2005.

• Did Cephalon cross the off-label line in promoting its narcolepsy drug Provigil? According to Business Week Online, Cephalon paid a physician — whose study on the use of the drug for treatment of ADHD reported positive results — to give talks to physicians. “[The speaker] says he does not bring up the use of Provigil for ADHD in his talks, but he answers questions — as he is permitted to do — if one of the doctors in the group brings it up. … Cephalon says it never instructs doctors on what to say at such meetings.”

• Eli Lilly announced in a press release this fall that it was cutting 575 positions and restructuring many of its departments. According to the release, “Parts of the business-to-business (B2B) unit and U.S. medical division will be restructured to gain efficiencies. … U.S. medical will restructure clinical operations, reduce medical liaison support, and centralize regulatory activities and implement cost improvement measures in areas such as new clinical trials and continuing medical education.”

• A rash of new books critical of the pharmaceutical industry were released this fall. Among them were The Big Fix: How the Pharmaceutical Industry Rips Off American Consumers, by Katharine Greider; On the Take, by Jerome Kassirer, MD; and The Truth about Drug Companies: How They Deceive Us and What to Do About It, by Marcia Angell, MD.

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