State agencies are facing questions over the enforcement of existing regulations covering compounding pharmacies like the New England Compounding Center
Authorities in Massachusetts have been accused of failing to properly enforce regulations aimed at protecting patients from contaminated drugs, after the death toll from an outbreak of meningitis linked to a medicine made in the state rose to 14.
The specialised compounding pharmacy at the centre of the escalating health scandal is being investigated for breaches of state and federal laws.
A patient from Minnesota, one of almost 14,000 patients at risk of contracting the disease after being injected with the potentially tainted steroid produced by New England Compounding Center, has filed what is expected to be the first of many lawsuits against the company.
Now state agencies are facing questions over their enforcement of existing regulations. On Friday, a congressional committee called on the state’s pharmacy regulator to provide information about its oversight of the company.
Massachusetts is one of just 17 states with regulations designed to protect patients from the sort of health scare which has now spread to 11 states. Two former compounding pharmacists who now work in the quality control industry told the Guardian that the risk to patients would have been minimal had the regulations, known as USP 797, been enforced.
“It’s abysmal that the local authorities are calling for greater oversight” said Eric Kastango, a committee member of US Pharmacopeia (USP), the industry body behind regulations governing compounding sterile drugs. “If someone just enforced Massachusetts law, these cases could have been avoided. They failed in their responsibility for enforcing what they already had.”
The scale of the outbreak makes it by far the worst of a series of fatal infections and overdoses connected to specialised “compounding” pharmacies.
Each case has prompted calls for federal oversight of the drug-producers, which are not subject to the same controls as mass manufacturers but whose regulation falls between the state board of pharmacy, the state department of health and the Food and Drug Administration, which regulates the pharmaceutical industry.
Kastango questioned how closely the state board of pharmacy had inspected NECC’s books and said that the regulations adopted by the state to protect patients, if properly applied, should have avoided contamination.
“If they had complied with USP 797 they would have avoided contamination. They would have found the source of it and remediated it. In my heart of hearts, I believe that.”
He said a company complying with the regulations would have more effectively “tested and they would have been monitoring their environment. They would have been cleaning the facilities. They would have been able to detect deviation in the process and they would have picked this up.”
The process to make the steroid was “extremely complex”, requiring two major compounding procedures, one of which involves taking the solution and pumping it into vials without contamination. It would have been considered “high risk”, he said.
Kastango, a consultant in quality control who has 30 years experience in compounding, said that a recent, as yet unpublished analysis by the USP has found that in almost all of the recent cases where there have been health scares linked to compounding pharmacies, a breach of regulation USP 797 had been involved.
Kate Douglas, a former director of a compounding pharmacy who is now president of Performance Strategies LLC, which consults sterile compounding pharmacies on safety issues, said not enough was being done by state boards to enforce regulations and called for more funding for states to ensure compliance.
“I can walk into a pharmacy and tell you within an hour whether they are following USP 797,” she said. “But they need to find a way to get them inspected and hold them accountable. It’s a challenge for state board of pharmacies. They need to make sure they are knowledgeable about 797 and maybe more funds are needed for states to do that.”
She added: “If you are a nurse or physician, you are held accountable to state regulations and you have to do the right thing and sometimes doing the right thing takes time. We can only reduce the risk of contamination, it can never drop to zero but if you follow the standards of practice you won’t be killing people.”
The Massachusetts office of health and human services said it had taken “swift action” against the NECC, but pointed to loopholes in regulatory requirements which left them powerless. The state department of public health called on Congress to act to address the need for new laws.
On Thursday, it accused the company of violating one state law which requires compounding pharmacies to only produce drugs to specified patients with a prescription.
In a joint press briefing with the FDA and the Centers of Disease Control and Prevention, Madeleine Biondolillo, the department’s director of heathcare and safety, said: “So, you know, NECC under Massachusetts board of pharmacy licensing regulations was licensed to deliver compounded products in response to individual patient specific prescriptions.
“And it looks through the investigation as though they have violated that aspect of the state licensing regulation despite their assertion that they were operating under the regulations.”
In a statement to the Guardian, the department said: “The FDA and the Massachusetts Board of Pharmacy have conducted joint reviews of NECC for more than a decade. These collaborative investigations are essential to maximizing regulatory oversight, and ensuring public safety.
“We’ve taken swift action to date, including securing the surrender of the company’s license, obtaining a recall of all of its products and promptly notifying all providers and patients. We are jointly examining all root causes of these events with the FDA, and we are committed to ensuring that all responsible parties are held accountable.
“We urge Congress to act quickly to address the need for new laws on the federal level to fill in the regulatory gaps, so that there is clear authority over regulating these practices.”
Federal and state regulators have also come under scrutiny for allowing a previously unknown pharmaceuticals sector known as compounding to grow at such a pace without much federal oversight. The industry has grown so large that some of the companies operate more like drug manufacturers than pharmacies, critics say.
In 1997, the FDA got Congress to pass a law giving it more power to regulate compounding pharmacies. But in 2002, the US Supreme Court struck down its no-advertising provisions on First Amendment grounds, leaving the rest of the law in limbo.
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