Answer: Monitoring postmarketing study commitments.
The FDA lacks an effective system for monitoring postmarketing study commitments. See the latest OIG Report, dated June 2006.
Omnicare In Trouble
Omnicare is the nation’s largest supplier of prescription drugs for nursing homes serving approximately 1.4 patents or more than half the market. However, the company appears to be under investigation for its Medicaid billing practices in three states: Massachusetts, Ohio and Michigan Omnicare’s top executive in Michigan has been indicted on racketeering and Medicaid fraud charges. A spokesperson for the Michigan Attorney General’s Office says the investigation is far from finished. In January 2006, Omnicare disclosed that the U.S. Attorney’s Office in Massachusettts had subpoenaed documents that focused on its relationships with drug manufacturers and distributors. In addition Johnson & Johnson in 2005 disclosed that its company received a subpoena in September 2005 from the U.S. Attorney’s Office in Massachusetts “seeking documents related to sales and marketing of eight drugs to Omnicare, Inc.”