Pharmacy Owner Takes 5th in Meningitis Hearing

The owner and co-founder of the New England Compounding Center, the pharmacy at the center of a deadly fungal meningitis outbreak, declined to testify before a congressional hearing today.

When pressed by members of Congress on his role in ensuring safe and sterile products, Barry Cadden invoked his Fifth Amendment right.

On advice of counsel, I respectfully decline to answer on the basis of my constitutional rights and privileges including the Fifth Amendment of the Constitution of the United States, he saidat the hearing in Washington, D.C.

The House of Representatives had subpoenaed Cadden to the hearing to address the outbreak that has sickened 461 people in 19 states and killed 32.The outbreak has been traced to contaminated vials of methylprednisolone acetate, an injectable steroid used to treat back and joint pain made by Caddens pharmacy.

But the Subcommittee on Oversight and Investigations panel became clearly frustrated with the testimony of U.S. Food and Drug Administration Commissioner Dr. Margaret Hamburg.

Republicans lawmakers noted inspections of NECC going back to 2002 that found sterility issues at the facility, and asked why the FDA had not taken action against the pharmacy.

You are in charge of the FDA. You are the chief honcho. Youre the great Pooh-Bah of the FDA and Im asking you, basically, could you have prevented this tragedy? And you are saying you cant because you didnt have jurisdiction? said Rep. Cliff Stearns, R-Fla.

I think it is very hard to know if any one action that we might have taken could have stopped this terrible tragedy, Hamburg replied, adding that in her opinion, the FDA did nothing wrong.

The commissioner told the panel that her agency needed stronger authority over compounding pharmacies.

The challenge we have today is that there is a patchwork of legal authorities that oversee the action we can take, said Hamburg. She said there were gaps and ambiguity in the FDAs authority, and described a crazy quilt of laws.

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Pharmacy Owner Takes 5th in Meningitis Hearing