- House and Senate negotiators reach two-year budget deal
- Congress seeks ban on in-flight calls
- Michelle Malkin’s Twitchy site sold to owners of Townhall, HotAir: report
- GM’s Barra to be first woman to run top American carmaker
- China: Poisonous smog is a military asset, if you think about it
- Texas woman admits to sending ricin to Obama
- Ron Paul on son Rand: ‘I think he probably will’ run for president
- Cold War heats up again in the Arctic: Russian airfield reactivated after 20 years
- 6-year-old boy suspended for sexual harassment over kiss
- Voters deciding Mass. congressional contest
Mass. officials find problems at compounding pharmacy
BOSTON (AP) — Water from a leaking boiler collected just outside a room that was supposed to be sterile. Floor mats used by technicians were filled with dirt and debris. Drugs were shipped out before the company even confirmed they were sterile.
State officials said Tuesday that they found these and other problems at the New England Compounding Center during a preliminary investigation into the company, linked to a deadly outbreak of meningitis.
The probe can’t yet conclusively prove what caused the outbreak, a top health official said. In the meantime, MassachusettsGov. Deval Patrick said he wants to tighten oversight at similar companies, including with surprise inspections — the first of which took place Tuesday.
The state also has moved to permanently revoke the company’s operating license, as well as the licenses of its top three pharmacists.
“Those whose laboratory practices caused this outbreak should never practice pharmacy or manufacture in Massachusetts again,” Mr. Patrick said.
The outbreak of fungal meningitis, an inflammation of the lining of the brain and spinal cord, has sickened 308 people, including 23 who have died, in 17 states. The outbreak has been linked to a steroid made by the NECC and taken mainly for back pain. Compounding pharmacies such as NECC custom mix solutions in doses or forms generally not commercially available.
The federal government is conducting a criminal investigation.
The state said Tuesday that its preliminary investigation, which began last month after the company first was suspected in the growing outbreak, found batches of drugs ready for general distribution but not labeled for specific patients.
Its state license permits the company to fill only specific prescriptions for specific patients, and distributing drugs in batches like a manufacturer would violate that, said Dr. Madeleine Biondolillo, director of the state Department of Public Health’s Bureau of Healthcare Safety.
But company attorney Paul Cirel said it’s “hard to imagine” state regulators weren’t previously aware of the scale of its operations because they’ve worked so closely together. The state Board of Registration in Pharmacy has always had complete access to the facility, and board members were there as recently as last summer, he said.
“NECC’s transparency in dealing with the board since inception in 1998 demonstrates its good-faith intention to operate in compliance with the requirements of its license,” Mr. Cirel said.
Besides possible state license violations, Dr. Biondolillo said the inspections also revealed “several health and safety deficiencies” at the NECC facility in Framingham, just west of Boston.
Three lots of steroids produced by the company are suspected in the meningitis outbreak, and the company shipped orders from those lots 13 times before receiving the results of its own tests to confirm those lots were sterile, Dr. Biondolillo said. Some medication was shipped as many as 11 days before the company received test results, she said.
Dr. Biondolillo also detailed signs of flawed sterilization procedures, including black specks of fungus in sealed vials of the steroids, which were returned to the company during a recall.
Investigators found the company didn’t sterilize its products long enough and didn’t adequately test whether its sterilization equipment was working, she said.
By Donald Lambro
Growth spikes are little more than trend-free anomalies
- Obama takes 'selfie' at Mandela's funeral service
- Harry Reid's visa pressure cooker
- Somber duty: U.S. presidents in hot demand at Mandela's memorial
- American bourbon now better than Scottish whiskey: U.K.-born expert
- Chinese man fed up with his girlfriend's shopping jumps to his death
- CARSON: Why did the founders give us the Second Amendment?
- Israeli P.M. Benjamin Netanyahu backs out of Nelson Mandela funeral
- Galaxy S4 owner claims Samsung tried to silence him after phone caught fire
- FITTON: A closer look at the Benghazi lie
- Obama lied about Syrian chemical attack, 'cherry-picked' intelligence: report
Independent voices from the The Washington Times Communities
A column dedicated to discussing politics, national security, civil liberties, and education.
Criticism may not be agreeable, but it is necessary. It fulfills the same function as pain in the human body. It calls attention to an unhealthy state of things.
The “Silver Tsunami” created by aging Baby Boomers is hitting America. Let’s explore how we adjust to it, enjoy it and defy negative expectations about age.
Find the latest news and happening that effect those in the Washington D.C., Northern Virginia and Maryland Metro region.
White House pets gone wild!
Let it snow