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The Decline In FDA Enforcement Activity

Posted July 12, 2006 in LegalCommittee on Government Reform, FDA, Government, U.S. Food and Drug Administration, United States

Congressman Waxman’s United States House of Representatives Committee on Government Reform issued a report entitled “Prescription for Harm/The Decline in FDA Enforcement Activity” in June 2006.  Enforcement is down and our FDA-related filings are up.  Any relationship?

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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.”

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