Barry Cadden, the co-founder of the New England Compounding Center whose tainted steroid injections have sickened patients nationwide, repeatedly cited the Fifth Amendment, declining to answer questions from the House Energy and Commerce Committee on Wednesday.
The questions Cadden declined to answer were regarding unsterile conditions at the plant as well as its culpability in recent meningitis-related deaths, reports USA Today.
Thirty-two people have died so far in the meningitis outbreak that has sickened hundreds. The House committee’s investigations subcomittee is holding its first of what will likely be several hearings about the 461 cases of fungal meningitis linked to the NECC’s contaminated steroid drugs.
Whenever he was asked a question, Newser notes that Cadden responded by saying:
“Under advice of counsel, I respectfully decline to answer under basis of my constitutional rights and privileges, including the Fifth Amendment.”
The only time he did not respond this way is when he was asked if he would answer all of the questions this way. He simply responded, “yes.” The testimony was disappointing for those who are seeking answers in the wake of a scathing report about the NECC that the FDA released recently.
Subcommittee Chairman Cliff Stearns (R-FL) asked Cadden, “What explanation can you give to those who have lost their loved ones?” He also told Cadden that his plant was guilty of “a massive failure of sterilization.”
Along with questioning Barry Cadden, they also questioned Margaret Hamburg, the Food and Drug Administration commissioner, about why her agency did not do more to stop the problems at NECC.
Stearns cited the fact that the FDA issued a warning letter to NECC in 20045 about dangerous conditions at the compounding center but did not go further. Stearns stated to Hamburg, “This was a complete and utter failure on the part of your agency.”
Hamburg also added about the lack of response from the FDA, “Unfortunately, we have an unclear, fragmented regulatory framework.” She added that Congress should clarify the FDA’s authority over large-scale “non-traditional” compounders like NECC.
Several Republican members of Congress have expressed their frustration at the FDA, saying that the administration needs to use the authority it has instead of asking for new powers. Rep. Henry Waxman (D-CA) cautioned however:
“Let’s not lose sight of the wrongdoer as we go around blaming the regulators. The regulators deserve blame, but the primary blame, in my mind, is the company.”