Thursday, September 17, 2015

Outbreak Anniversary Brings Mixed Results

By Walter F. Roche Jr.

It was  three years ago this week when a Nashville, Tenn physician raised the first alarm in what became one of the worst outbreaks in U.S. history, eventually sickening 778 patients and killing 76 of them.
The outbreak of fungal meningitis, fueled by fungus laden medications injected into the spines and joints of unsuspecting patients across the country, triggered a lengthy criminal investigation leading to the indictment of 14 people, two charged with 25 counts of second degree murder.
It prompted congressional hearings and, eventually, a change in the federal law governing drug companies compounding drugs for sterile use.
The culprit, the New England Compounding Center of Framingham, Mass., ended up in bankruptcy court even as the death toll was climbing. A liquidation plan for that company has produced a $200 million fund that could, by the end of this year, provide some long sought financial relief to victims and their survivors.
In addition to the change in federal law, several states have enacted new statutes or imposed new regulations to prevent a recurrence.
Officials of the U.S. Food and Drug Administration, meanwhile, cite stepped up enforcement in the wake of the outbreak.
Lyndsey Meyer, an FDA spokeswoman, said that some 250 inspections of drug compounders have been conducted in the past three years resulting in 55 warning letters. Three compounders have entered into consent agreements and one pleaded guilty to a misdemeanor criminal violation.
She also cited the 131 count NECC indictment.
Calling FDA's oversight of compounding pharmacies "vigorous," she said the FDA "continues to pursue regulatory actions as appropriate, to protect the public from adulterated and misbranded compounded drugs."
But  FDA's actions and the new law itself have left some wondering whether there has been any real improvement in the regulation of drug compounders.
Dr. Michael Carome of Public Citizen, who serves on an advisory committee created by the new law says the law itself was a step backwards.
"It (the new law) created a new category of companies, called outsourcing facilities, that are allowed to mass produce standardized drug products without seeking FDA pre-market approval, particularly during drug shortages. This legalized what previously was illegal drug manufacturing," Carome wrote in an email response to questions.
Citing the high percentage of outsourcers found in violation during initial inspections, Carome said those results "indicate that many facilities engaged in the production of sterile drugs are not complying with the requirement intended to ensure that products are sterile. This obviously poses a significant threat to patient health."
David Miller, who heads the International Association of Compounding Pharmacists, says he has his own concerns about the new law and the way the FDA is interpreting and enforcing it.
He said pharmacists are getting "completely contradictory" directives from the FDA and state pharmacy boards on key issues including the compounding of various  drugs, including oncology medications, for advance use in a physician's office.
Some states, he said, have expressly approved that practice, while the FDA has taken an opposite stance.
"It's an incredibly muddy situation" Miller said, citing laws in Maryland, Michigan and North Carolina.
Meyer, the FDA spokeswoman, said while the law does allow pharmacists to apply for exemptions, the statute still requires that pharmacists have a patient specific prescription for compounding drugs.
Miller said there have been "a ton of state law changes" in the wake of the outbreak.
 "It provided a jolt to the state boards of pharmacy," he said, citing increased training for inspectors. "It's very clear the real success has been at the state level. The boards have taken a more assertive role," he said, adding that generally states move much more quickly than the federal government in response to regulatory issues.
For the living victims of the outbreak, aside from waiting for the outcome of lengthy legal processes, many remain recovering from the outbreak and still suffering from the chronic pain that led them to allow a physician to inject steroids in their spines and joints in the first place.
"Physically, I'm no better.  I hurt all the time, 24/7/365," said Dennis O'Brien of Cookeville.   "But, my attitude and outlook must remain positive  or I'd fall into a rabbit hole."

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