Arrested: compounding pharmacist linked to 2012 meningitis deaths
The 46 year-old Massachusetts man, who is part of an ongoing criminal investigation, was arrested at Boston’s Logan International Airport as he was about to board a flight to Hong Kong.
The US Attorney’s Office apprehended Chin on one count of mail fraud linked to his involvement with New England Compounding Center (NECC).
The criminal complaint charged Chin with participating in a scheme to fraudulently label one lot of methylprednisolone acetate (MPA) – a steroid – as sterile and fit for human use, and to ship it to NECC’s customer Michigan Pain Specialists.
The affidavit alleges Michigan doctors then injected the compound into patients, causing 217 to contract fungal meningitis, of which 15 died. 751 patients nationwide were diagnosed during the outbreak.
US Food and Drug Administration (FDA) Special Agent Benedict Celso said Chin instructed pharmacy technicians to fraudulently complete cleaning logs at the end of each month to pretend the clean rooms had been properly maintained.
‘We owe the victims’
The healthcare fraud unit of the US Attorney’s Office had been alerted that Chin planned to leave the country, reported Reuters.
"We owe it to the victims in this case not to lose him to a foreign jurisdiction," said prosecutor George Varghese.
Chin’s lawyer said his client planned to attend a wedding in Hong Kong, and did not mean to flee the US.
At the hearing on Thursday, Chin was ordered to surrender his passport, post a $50,000 unsecured bond and remain under house arrest until next week. The maximum sentence for the mail fraud charge is 20 years in prison, followed by three years’ probation and a $250,000 (€194,000) fine.
Compounding: ‘a national safety signal’
Sarah Sellers, the President of drug safety consultancy q-Vigilance, told Outsourcing-Pharma.com Chin’s case “is on the sharp end of an entrenched, systemic problem” for compounding pharmacies.
“A lack of a) infrastructure, b) knowledge and expertise, and c) regulatory frameworks for sterile […] production” makes sterile manufacturing in these centres more thorny than in contract manufacturing organisations (CMOs), she said.
Compounding pharmacies “are designed, licensed and staffed for dispensing drugs, not for navigating what can be extraordinarily complex sourcing and manufacturing conditions that impact product quality and safety.
“For example, where a pharmacy may compound from non-sterile powders, the specifications as stated on certificates of analysis may be incomplete regarding physical-chemical parameters that may impact a specific product.”
If a powder is originally produced as a food-grade chemical but repackaged for compounding an injection, residual solvents and microbes may remain unknown.
“This set of circumstances does not exist in CMOs, which are designed, staffed, and overseen specifically for sterile drug manufacture.”
The recent upswing in recalls from compounding pharmacies “represents a major national safety signal,” Sellers told us.
In July 2014, the FDA released draft guidance – in a section of the Drug Quality and Security Act called 503B – which allows drug compounders to voluntarily register as CMOs.
Sellers described the new framework, which will increase federal oversight for participating pharmacies, as “long overdue,” and a force for improving safety and creating business opportunities.
