Jose Carlos Morales co-owner of Pharmovisa, Inc. and PharmovisaMD Inc., pleaded guilty to to paying kickbacks and submitting fraudulent claims for pharmaceuticals to Medicare and Medicaid. According to the Department of Justice, Morales and his co-conspirators submitted false and fraudulent claims to the government agencies, which amounted to approximately $23,367,775.
Last month FDA published an amendment to its July 10, 2012 UDI proposed rule (77 FR 40736). The amendment moves up the dates of compliance. Comments on this amendment to the proposed rule are due by December 19, 2012.
“The unique identification system will enhance the flow of information about medical devices, especially adverse events and, as a result, will advance our ability to improve patient safety.” -FDA Commissioner Margaret A. Hamburg, M.D.