State, Federal Officials Intensify Investigation of Serono Marketing Practices for AIDS-Wasting Drug
State and federal officials have intensified their investigation of Swiss biotechnology company Serono's marketing practices for its AIDS-related drug Serostim, the Wall Street Journal reports (Windham, Wall Street Journal, 4/15). Serostim, which is a growth hormone, is prescribed to HIV-positive patients to treat AIDS-related wasting. Many AIDS patients receive the drug through the state-federal Medicaid program, which includes the medication in its drug formularies (Kaiser Daily HIV/AIDS Report, 1/20). The company received a subpoena from the U.S. attorney's office in Boston in 2001 requesting nearly 10 years worth of documents pertaining to the drug, and in 2002 the company received similar requests from authorities in California, Florida, Maryland and New York. The criminal and civil investigations seem to be focusing on whether the company violated federal and state false claims acts or antikickback laws, which prohibit drug companies from offering incentives to doctors to prescribe a drug covered by the government, individuals familiar with the investigations say, according to the Journal. The Department of Justice has questioned HIV specialists Howard Grossman and Danielle Milano about whether the company offered to pay for a trip for them to attend a 1999 AIDS conference in Cannes, France. In addition, federal officials have subpoenaed pharmacy contracts, marketing documents and invoices to determine whether the company gave pharmacies rebates or discounts without reporting them, as required under Medicaid rules. Serono spokesperson Lisa Ellen said that the company does not comment on legal matters, according to the Journal. In addition, the U.S. attorney's office in Boston said it does not confirm or deny investigations, the Journal reports (Wall Street Journal, 4/15).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.