Compounding Pharmacies Subject on Capitol and Beacon Hill
On Capitol Hill in Washington, members of the House Energy and Commerce Committee grilled a series of witnesses about the fungal meningitis outbreak that originated from injectable steroids manufactured at the New England Compounding Center in Framingham, Massachusetts.
So far, the outbreak has sickened about 440 people and led to more than 30 deaths nationwide. In his introductory remarks, committee chair Cliff Stearns noted that NECC had had a history of problems over many years. Company president, co-founder and director, Barry Cadden appeared, but invoked his fifth amendment right, answering none of Stearns' questions.
A number of the committee's members are physicians and were unrelenting in their questioning, in particular, of FDA commissioner Doctor Margaret Hamburg. They also questioned doctor Lauren Smith, interim commissioner of the Massachusetts Department of Public Health. She testified the meningitis outbreak has led to a joint investigation with the FDA, and the enacting of emergency state regulations to give greater scrutiny to the industry.
"Require sterile compounding pharmacies to report both volume and distribution information to us. Licensed pharmacies will also have to report when they are the subject of any state of federal investigation
we have also begun unannounced inspections of all sterile compounding pharmacies in Massachusetts."
Smith also said Massachusetts is exploring changes to state law, has established a special commission and is examining best practices in other states. Among those who also testified today was the widow of Judge Eddie Lovelace -- one of the victims of the outbreak, who spoke about the heartbreak her family has experienced. At the same time as the hearing on Capitol Hill, the first of three hearings was taking place on Beacon Hill in Boston, to examine similar questions and concerns.