The owners of New England Compounding Center, the Framingham company at the heart of a nationwide outbreak of fungal meningitis, also own a related pharmacy in Westborough, one of whose executives is a board member and former president of the state agency that regulates pharmacies.
Sophia Pasedis was appointed to the 11-member Massachusetts Board of Registration in Pharmacy in June 2004 and was reappointed in 2008. She is vice president of regulatory affairs and compliance at Ameridose, according to the company’s website.
Ameridose, a company licensed and regulated by federal authorities to manufacture medications on a large scale, shares the same owners as New England Compounding. Until June 2011, its headquarters were right around the corner from New England Compounding in Framingham.
The state Department of Public Health, which oversees the pharmacy board, said in a statement Tuesday that Pasedis “recused herself from all matters on Ameridose and [New England Compounding] going back to her appointment.”
Concerns about oversight of compounding companies have been raised after the meningitis outbreak that is now blamed for 11 deaths. Government investigators have traced the illness to a potentially tainted steroid medication made by New England Compounding. The steroid was injected near a patient’s spine to treat back pain.
State health officials have said New England Compounding was licensed only to dispense and mix medications for individual patients, raising questions about how and why it was allowed to ship thousands of vials of the drugs to facilities nationwide. The company also had contracts with the US Department of Veterans Affairs, according to federal records.
As federal and state investigations of New England Compounding grow, so, too, do the number of reported illnesses and deaths linked to the firm’s steroid treatment. The Centers for Disease Control and Prevention said Tuesday that 119 people have been sickened, and the agency added a 10th state, New Jersey, to the list of those with confirmed cases.
Ameridose, which supplies medications to hospital pharmacies, has about 400 employees and $100 million in annual revenue, according to federal contracting data from this year. New England Compounding had about 21 employees and $8 million in annual revenue as of 2009, according to the latest federal records available.
Both companies have received thousands of dollars in government contracts, records show. New England Compounding received $21,390 from the US Department of Veterans Affairs for eight orders of drugs and chemicals from 2006 to 2009. Ameridose has received more than $822,000 from Veterans Affairs and the Department of Defense since 2007.
State health officials have declined to answer questions about whether the two companies have shared manufacturing or other operations, but indicated in a statement Tuesday night that questions about the companies’ corporate relationships will be included in their investigation of the meningitis outbreak.
“The Department of Public Health’s joint investigation with the CDC and the FDA will be comprehensive and will cover all issues around this serious outbreak, including corporate governance,” the statement said.
Andrew Paven, a spokesman for Ameridose and New England Compounding, said in a statement: “Ameridose is a separate entity from New England Compounding Center, with distinct operational management. We have separate production facilities, separate processes, and operate at separate locations in different cities.” Although the two companies share “common ownership,” he added, they “operate under separate registrations and different licensure.” New England Compounding was founded in 1998, and Ameridose in 2006, according to state records.
The owners of both companies are Barry Cadden and Gregory Conigliaro, Paven said. Cadden is the president, pharmacist in charge, and an owner of New England Compounding and is responsible for the company’s pharmacy operations. He is also a minority shareholder of Ameridose, Paven said, but is not involved in any operations at Ameridose.
State records show that Cadden’s pharmacy license is currently restricted, meaning he is barred from practicing because of a nondisciplinary agreement or order by the pharmacy board. The records posted on the board’s website do not explain the reason.
Conigliaro is an owner and executive vice president of Ameridose and an officer and minority shareholder of New England Compounding, but not involved in any of that company’s pharmacy operations, Paven said.
Conigliaro, who owns a home in Southborough, has not returned calls for comment. Neither has Cadden, who owns property in Wrentham.
Pasedis, the Ameridose executive and pharmacy board member, declined comment Tuesday night through a woman who answered the door of her Quincy home and identified herself as Pasedis’s daughter.
US Representative Edward J. Markey, a Malden Democrat, said he will introduce legislation to strengthen the oversight of compounding pharmacies. The legislation will require certain pharmacies that engage in interstate commerce to register with the Food and Drug Administration and comply with basic minimum safety standards, among other things.
“These compounding pharmacies are operating as factories, mass producing and packaging specialized new drugs in large quantities and then sending them over state lines,” said Markey, senior member of the Energy and Commerce Committee, which has jurisdiction over the FDA.
The CDC has said hospitals and doctors should contact patients who received injections for low back pain using methylprednisolone acetate (80mg/ml) made by New England Compounding.
The agency moved back the time frame that caregivers began giving the potentially contaminated injections to May 21, 2012. The CDC previously said the injections began in July and were recalled Sept. 26, which means that additional infections, which can take up to four weeks to appear, may continue mounting until Oct 26.