Westborough Optimistic Ameridose Will Reopen
Ameridose LLC of Westborough kept a relatively low profile until a fatal meningitis outbreak tied to its sister company, New England Compounding Center (NECC) of Framingham, hit the nation this fall.
But as the depth of meningitis cases from contaminated injections became known, regulators turned their heads toward Ameridose to see whether the company that shared an owner with NECC followed safer sterility practices.
It turns out it didn't. Though no medication released by Ameridose has caused any known illness, the company recalled all drug products in circulation before an investigation by the U.S. Food and Drug Administration (FDA) uncovered a number of areas in which the Westborough company failed to meet standards for sterility at its Flanders Road facilities.
Ameridose officials have agreed to correct the problems and have insisted the company will reopen after voluntarily closing in October, but it also formally laid off more than 700 employees two weeks ago. When it does reopen, company officials said, it will be at reduced staffing levels.
But if the company fails to rebound, it could mean a sizeable hit to Westborough in the form of job losses and reduced tax revenue.
Westborough Town Planner Jim Robbins said layoffs are a chief concern, as the laid-off Ameridose employees won't be spending money in town.
"Anytime there's a loss of jobs, there's always a spinoff effect with impact to local business," Robbins said.
Ameridose began leasing buildings on Flanders Road in 2008, and the company eventually purchased the building at 205 Flanders Rd. in July for $4.5 million.
Presumably, the real estate taxes on the leased buildings will continue to be paid by their current owners, but the shuttered Ameridose is on the hook for real estate taxes at its 76,000-square-foot building. According to the Westborough Tax Collector's office, the most recent fiscal 2012 real estate tax bill for that property was due Nov. 1 and it's not current. Ameridose owes the town $16,056 in past-due taxes. The total bill for fiscal 2012 was $63,879.
A larger chunk of town revenue is generated by the personal property tax bill Ameridose pays on its equipment, which is valued at $5.9 million, according to the Westborough Assessor's office. The fiscal 2012 bill was $113,339 and Ameridose is current on those payments.
Westborough Town Manager Jim Malloy said he's hopeful the company will reopen and continue to be a source of both jobs and tax revenue. Malloy said he has spoken with Ameridose officials, who have indicated they plan to reopen by the end of November.
That would be ideal, as the company is one of the town's 10 largest employers, according to Malloy. He said the company has made significant investment in Westborough through expansion since moving to town, and after visiting Ameridose facilities in the past, Malloy said he was surprised the FDA found problems with sterility.
"My impression walking through the plant is that it was a very professional-looking pharmaceutical company," Malloy said.
Ameridose officials did not return repeated phone calls seeking comment.
Co-owner and former NECC pharmacist Barry Cadden has remained mum on the situation. He exercised his Fifth Amendment rights during a Nov. 14 congressional hearing to which he was subpoenaed. According to a Nov. 13 letter from Cadden's Boston-based attorney, Bruce A. Singal, to the Investigations and Oversight Subcommittee of the House Energy and Commerce Committee, Cadden was willing to testify but Singal advised against it.
Singal said questions about the causes of the meningitis contamination at NECC have "anguished" Cadden.
Meanwhile, Cadden and his co-owner, Gregory Conigliaro, have agreed to work with federal and state regulators to correct problems found at the Westborough sites, but it's unclear whether or when they will be resolved and when the firm will resume work.
Among the FDA's observations were the company's failure to evaluate clients' complaints about side effects caused by drugs manufactured by Ameridose, the presence of insects and at least one bird inside what was supposed to be a sterile environment, failure to investigate microbiological contaminants used in solutions to make injectable drugs, and inadequate gowning of personnel who manufactured drugs.
Beyond Westborough, an Ameridose shutdown has apparently sent health care providers into a frenzy as drugs that were supplied to Massachusetts hospitals by NECC and Ameridose are now hard to come by, according to the Massachusetts Hospitals Association (MHA).
The MHA, in a statement dated Nov. 13, said the Massachusetts Department of Public Health (DPH) was trying to figure out how to correct drug shortages, and was considering measures not usually allowed under current regulations, including allowing hospital pharmacies to ship drugs to other hospitals within the same systems and extending the amount of time medications can be used while ensuring safety measures are met.
"MHA and our member hospitals will continue to meet with DPH, and will say more as additional innovative ways for tackling the drug shortages crystallize," the statement said.
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