The country's top medical regulator is preparing to tell Congress that new laws are needed to police large specialty pharmacies like the one at the center of a deadly meningitis outbreak.
Testimony released ahead of the first congressional hearing on the incident shows that Food and Drug Administration Commissioner Margaret Hamburg will ask lawmakers to give her agency more authority and funding to oversee compounding pharmacies. She plans to testify before the House Energy and Commerce Committee.
About 440 people have been sickened by contaminated steroid shots distributed by New England Compounding Center, and more than 32 deaths have been reported. Congress is meeting to consider new restrictions on compounding pharmacies, which currently operate in a legal gray area between state and federal regulation.
Meantime the owner and director of the specialty pharmacy tied to the outbreak has declined to testify before a congressional committee investigating the matter.
Barry Cadden, co-founder of the New England Compound Center, told lawmakers he would use his Fifth Amendment right to not answer questions in order to avoid self-incrimination.
After repeated questions by House lawmakers, Cadden told the House Energy and Commerce Committee: "Under advice of counsel, I respectfully decline to answer under basis of my constitutional rights and privileges, including the Fifth Amendment."
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