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| Congress subpoenas owner of company blamed for meningitis outbreak | Congress subpoenas owner of company blamed for meningitis outbreak |
| (4 months later) | |
| The head of a pharmacy company blamed for a meningitis outbreak that has killed at least 30 people in the US has been subpoenaed to appear before lawmakers in Congress after refusing to give evidence voluntarily. | The head of a pharmacy company blamed for a meningitis outbreak that has killed at least 30 people in the US has been subpoenaed to appear before lawmakers in Congress after refusing to give evidence voluntarily. |
| Barry Cadden, the co-owner of the New England Compounding Center (NECC) – which is believed to have sent out thousands of contaminated steroid shots from premises in the Boston suburb of Framingham – had been asked to attend a session called by the House's energy and commerce committee along with state and federal regulators. | Barry Cadden, the co-owner of the New England Compounding Center (NECC) – which is believed to have sent out thousands of contaminated steroid shots from premises in the Boston suburb of Framingham – had been asked to attend a session called by the House's energy and commerce committee along with state and federal regulators. |
| But the chief pharmacist declined, according to members of the committee. | But the chief pharmacist declined, according to members of the committee. |
| "With more than 400 people infected and 30 deaths, it is critical that we hear directly from the head of the facility linked to the outbreak," said committee chairman Fred Upton and Ranking Member Henry Waxman in a statement. "Since Mr Cadden has indicated he will not appear voluntarily, we are left with no choice but to issue a subpoena." | "With more than 400 people infected and 30 deaths, it is critical that we hear directly from the head of the facility linked to the outbreak," said committee chairman Fred Upton and Ranking Member Henry Waxman in a statement. "Since Mr Cadden has indicated he will not appear voluntarily, we are left with no choice but to issue a subpoena." |
| On Monday, the committee announced that Dr Margaret Hamburg, commissioner of the Food and Drug Administration (FDA), will be testifying before lawmakers on 14 November. | On Monday, the committee announced that Dr Margaret Hamburg, commissioner of the Food and Drug Administration (FDA), will be testifying before lawmakers on 14 November. |
| As of Wednesday morning, the Centers for Disease Control and Prevention has confirmed 409 cases of fungal meningitis in 19 states. The contaminated steroid injections are also thought to be responsible for 10 peripheral joint infections. An update on figures in expected later in the day. | As of Wednesday morning, the Centers for Disease Control and Prevention has confirmed 409 cases of fungal meningitis in 19 states. The contaminated steroid injections are also thought to be responsible for 10 peripheral joint infections. An update on figures in expected later in the day. |
| Health regulators have formally matched the fungal meningitis to a contaminate found at the premises of NECC in the Boston suburb of Framingham. | 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. | 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. | 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. |
| Alongside Cadden and Hamburg, the congressional committee also invited James Coffey, director of the Massachusetts Board of Registration in Pharmacy, to testify. It is not yet known if he will appear. | Alongside Cadden and Hamburg, the congressional committee also invited James Coffey, director of the Massachusetts Board of Registration in Pharmacy, to testify. It is not yet known if he will appear. |
| 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. | 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. | 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. | 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. |
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