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Alyson Oliver, a Michigan attorney representing several injured victims of the fungal meningitis outbreak and the lead attorney in the effort to consolidate the fungal meningitis cases nationally continues to uncover serious concerns about how the Massachusetts Board of Registration in Pharmacy (BRPh) conducted business and specifically how it dealt with complaints against the New England Compounding Center (NECC) during former Governor Mitt Romney’s administration.
NECC, the supplier of the contaminated drugs in question, has been linked to the recent outbreak of fungal meningitis that has infiltrated 18 states and infected at least 344 people. Twenty-five patients have died to date. Oliver recently discovered that during the Romney administration NECC and its Manager of Record, Barry J. Cadden, were the subject of six complaints between 2003 and 2006. Massachusetts state records reveal that two of these complaints alleged that NECC and Cadden failed to comply with accepted pharmaceutical standards in compounding methylprednisolone acetate, the same drug that has been recalled by NECC and attributed to the outbreak of fungal meningitis and 25 deaths. Oliver documented a pattern of ineffectual oversight by Romney’s administration that led to NECC entering into a negotiated consent agreement where NECC was required to serve one year of probation and pay for a private consultant to monitor compliance. Further, according to these same records, the BRPh agreed that the non-disciplinary agreement would not be reported to the National Association of State Boards of Pharmacy or other outside agencies.
Now, Oliver’s additional investigation has revealed that during the Romney Administration, an industry insider with connections to NECC had a seat at the table when critical decisions about BRPh’s enforcement actions against NECC were discussed. According to the Boston Globe, Sophia Pasedis, Vice President of Regulatory Affairs and Compliance at Ameridose, was appointed to the BRPh in June 2004. Ameridose LLC and NECC are co-owned by Barry Cadden and his brother-in-law Gregory Coniglario. Massachusetts law provides that members of the BRPh are appointed by the Governor. Conceding there would be an obvious conflict if she voted or acted on issues involving NECC or Ameridose, Governor Romney’s appointee Pasedis has asserted that she recused herself from any board topics related to NECC or Ameridose. The Board’s recusal policies require announcement of recusal and that the recused member then exit the room. When the Board met in November 2004 to discuss NECC’s response to a proposed Consent Agreement, the minutes do not reflect that Sophia Pasedis recused herself or exited the room as required by Board procedures.
According to Reuters, Lauren Smith, interim commissioner of the Massachusetts Department of Public Health stated that Regulators has asked Pasedis to step down from the Massachusetts BRPh. Pasedis has refused to resign. According to the Boston Herald the recent investigations of the BRPh past actions have also brought to light other anomalies including missing meeting minutes from 2006 and 2008.

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