Head of compounding pharmacy blamed for outbreak that has killed 30 summoned to appear alongside drug regulators
The head of a compounding pharmacy blamed for a meningitis outbreak that has killed 30 people in the US has been summoned to appear before a House committee, alongside drug regulators.
The energy and commerce committee of the House of Representatives said Monday that Dr Margaret Hamburg, commissioner of the Food and Drug Administration (FDA), will testify before lawmakers on 14 November. Barry Cadden, co-founder of the New England Compounding Centre (NECC), which sent thousands of contaminated steroid shots across the nation, has also been asked to attend.
On Monday, the Centers for Disease Control and Prevention said 409 cases of fungal meningitis had been recorded in 19 states. The contaminated steroid injections are also thought to be responsible for 10 peripheral joint infections.
Health regulators have formally matched the fungal meningitis to a contaminate found at the premises of NECC in the Boston suburb of Framingham. Agents from the FDA raided NECC last month, as part of a criminal investigation. One of the areas under investigation is whether the company violated regulations by supplying bulk orders to clinics without matching the drugs to specific prescriptions or patients.
NECC has a chequered history of violating health and safety standards, having been cited on numerous occasions by the FDA prior to the latest outbreak. The company is already the subject of a number of civil lawsuits brought by people affected by the meningitis outbreak. After it was identified as the likely source of the infection, the NECC recalled all of its products, amid fears that other drugs had been contaminated.
The energy and commerce committee has yet to hear from Cadden. It has also invited James Coffey, director of the Massachusetts Board of Registration in Pharmacy, to testify.
Compounding pharmacies fill special orders placed by doctors for individual patients, turning out a small number of customised formulas each week. But some, like NECC, have in recent years grown into much larger businesses, supplying bulk orders of medicines to thousands of doctors and hospitals across the country.
House and Senate lawmakers have called for hearings to examine how the outbreak of fungal meningitis could have been prevented and if greater safeguards are needed in the oversight of compounding pharmacies, which operate in something of a regulatory grey area.
FDA officials said last month that new laws may need to be enacted, in order to clarify the federal government’s role in overseeing the sector.