'Loophole' found in federal drug law
A new federal law dealing with drug compounding creates the same sort of regulatory "loophole" that led to a deadly meningitis outbreak in 2012, the New Hampshire Board of Pharmacy is warning.
Bob Stout is vice president of the board, which licenses pharmacies here, including traditional "compounding" pharmacies that create customized medications for specific patients.
Stout said the board was stunned when the Drug Quality and Security Act of 2013 created a "hybrid" between traditional compounders and manufacturers. "Nobody saw this coming," he said.
Compounding pharmacies are regulated by the state boards of pharmacies, while drug manufacturers are under the oversight of the federal Food and Drug Administration.
But there isn't enough oversight in the Drug Quality and Security Act over the new "outsourcing facilities" it created, Stout said. "They're basically small manufacturers," he said. "Who knows who's going to watch over them."
Compounding pharmacies came under state and national scrutiny after a fungal meningitis outbreak that began in September 2012 was traced to contaminated injectable steroids manufactured by a Framingham, Mass., company. It turned out the company had been producing large quantities of certain drug products and shipping them to providers across the country, including two clinics in New Hampshire.
The outbreak sickened 751 people nationwide and caused 64 deaths; 14 people in New Hampshire suffered meningitis or joint infections.
The company, New England Compounding Center, closed and went bankrupt.
Since then, as federal and state inspectors began looking more closely at compounding, there have been many other drug recalls.
Last year, New Hampshire lawmakers passed a new oversight law for compounding pharmacies here, including regular inspections and labeling requirements.
And while the state law allows for "limited quantities" of certain drugs to be made for so-called "office use," for doctors to use on their patients, the pharmacy board has written rules limiting that to 50 doses, to prevent the kind of large-scale manufacturing done at NECC.
Meanwhile, FDA Commissioner Dr. Margaret Hamburg last year called for federal legislation giving the agency oversight of facilities that compound sterile drug products, including "clear authority" to proactively inspect such pharmacies and examine their records.
In a March 2013 blog posting, Hamburg cited the "legitimate role" of traditional compounding, but warned of "a new breed" of pharmacy compounding "that has outgrown the law and can pose a threat to the health of the public."
Stout said he expected the Drug Quality and Security Act would completely eliminate compounding for "office use." Instead, it created the new category of "outsourcing facilities" and exempts them from some FDA regulations.
Stout called that "very disturbing."
"It's exactly the loophole that caused the NECC crisis," he said.
The federal law allows outsourcing facilities to register with the FDA, but does not make such registration mandatory. And Stout is concerned that FDA guidelines call for "risk-based inspections" of such facilities.
"That means when something bad happens, they're going to go in," he said. "The whole concept of having no oversight unless there's a risk is just so counterproductive to where we've been trying to go with this whole thing."
FDA officials have acknowledged that the final version of the Drug Quality and Security Act didn't have everything they wanted. After it passed, Hamburg wrote, "While the law does not provide FDA with all the additional authorities sought, these provisions are a sign of progress."
In a media briefing last December, Hamburg told reporters the agency will be "encouraging" providers to "consider strongly" purchasing products from such regulated companies. She said the agency plans to post a list of such facilities.
But Hamburg acknowledged "there does remain some uncertainty about if a company does not choose to register with us, how we will be aware of them if there are problems."
At the same briefing, Jane Axelrad, who led the agency's response to the NECC crisis, said, "it will be difficult for us to identify compounding pharmacies that choose not to register as outsourcers and then try to hide out in the category of traditional compounders."
Axelrad said the FDA will not be able to do "proactive" inspections of such unregistered facilities. "We'll have to wait until we hear about them through either an adverse event report or quality complaint."
New Hampshire isn't waiting.
The Board of Pharmacy in March began inspecting licensed compounding pharmacies here, including hospital pharmacies that make their own sterile drug products. After some initial bumps, Stout said, the process has gone smoothly.
"It's been a great collaboration between our in-state facilities," he said. "The in-state licensees and the hospitals, everybody has been working together on this, and they've really done a fantastic job."
However, Stout said the Board of Pharmacy will not license any outsourcing facilities here. Also, 37 companies that previously were "dual licensed" as both pharmacies and manufacturers will be notified in coming weeks that those licenses, which expired June 30, will not be renewed, he said.
He expects the board's decision will be challenged by some out-of-state companies, but the state doesn't have the resources to ensure the safety of such facilities.Members of the pharmacy board recently met with officials from Sen. Kelly Ayotte's office to express their concerns about the Drug Quality and Security Act.
Liz Johnson, Ayotte's press secretary, said in an email: "Senator Ayotte's office has been in contact with the Board of Pharmacy, and she has brought their concerns to the FDA's attention. She believes it's critical that the FDA take into consideration the views of stakeholders as the law is implemented."
Meanwhile, Stout said the pharmacy board plans to work with the New Hampshire Medical Society to get the word out to providers who prescribe compounded drugs, including physicians, surgical centers, pharmacies and veterinary clinics, to purchase products made only by licensed facilities.
"They should do some due diligence," he said. "Don't just buy products that you think are OK."