PRESIDENT OF PHARMACY AT CENTER OF OUTBREAK REFUSES TO TESTIFY, ASSERTS FIFTH AMENDMENT RIGHTS

WASHINGTON, NOV. 14, 2012 – Rep. Cliff Stearns (R-FL), Chairman of the House Energy and Commerce Committee’s Subcommittee on Oversight and Investigations, believes that the U.S. Food and Drug Administration (FDA) had cause to close the New England Compounding Center (NECC), but failed to act.   Said Stearns, “In 2002, in response to several adverse events the FDA conducted an inspection of NECC, although finding violations, the FDA took four years to issue a Warning Letter.  When NECC challenged the FDA charge, it took another two years for the FDA to respond to the company’s claims.  Finally, in 2008 the FDA directed NECC to correct the violations and warned of follow-up inspections.  Now, we have 32 deaths and over 400 people sickened.” Stearns also noted that the FDA has failed to provide the requested information outlining how the FDA addressed the problems at NECC in hopes of determining why no actions were taken.

Earlier during the hearing, the widow of one of the victims, Joyce Lovelace, testified on her loss.  Also asked to testify was Barry Cadden, President of NECC, who refused to testify.

Also testifying was the FDA Commissioner, Dr. Margaret Hamburg, who contended that the FDA lacked authority to act even though the agency had documented violations at NECC.  Stearns expressed credulity with Dr. Hamburg’s contention and asked, “Have you come up with procedures and interpretations so that the manufacturers out there that are doing the same thing as NECC so that you can stop them?”  Dr. Hamburg responded that legislation was needed for the FDA to act.   

Stearns then directed a question to Dr. Lauren Smith, Interim Commissioner of the Massachusetts Department of Public Health (MDPH).  Asked Stearns, “Dr. Smith, you indicated in your opening statement that because of what happened (with NECC) people have been fired and suspended, is that true?   Dr. Smith answered “Correct.”  Back to the FDA Commissioner, Stearns asked, “Dr. Hamburg, have you fired or suspended anybody at the FDA because of this tragedy, yes or no?”  Dr. Hamburg answered, No.”

Stearns concluded the hearing by noting that if the FDA had the jurisdiction to go into NECC and take equipment then it had the jurisdiction to shut the company down.