"Houston (and anywhere else there’s a compounding pharmacy) we have a problem." So says FDA Commissioner Dr. Margaret Hamburg, who wrote a blog on FDA Voice expressing concern about the lack of regulatory authority over the facilities that make customized, prescription medicines like the contaminated steroids that killed 53 and sickened 733 people last year. (See our blog post, “Drugs ‘Compounded’ by Pharmacies: A Disaster Waiting to Happen.”)
Despite resistance by compounding pharmacies, according to AboutLawsuits.com, state and federal agencies have been investigating them, and not liking what they see. Such pharmacies are supposed to fill a specific need: making customized drugs to order for local patients when the meds are not available commercially or in the right delivery system. But some, apparently, operate more like, as AboutLawsuits puts it, “stealth drug manufacturers, selling products nationwide in large amounts without any federal oversight.”
The New England Compounding Center (NECC), the outfit that allegedly caused the outbreak last autumn of fungal meningitis, shipped some 17,000 vials of injectable steroids across the country, and even employed sales representatives to promote it. If that’s not Big Pharma behavior, what is?
It’s cold comfort that NECC is facing criminal charges, lawsuits and bankruptcy—what’s needed, says Hamburg, is a bigger hammer of authority.
As reported by Reuters, Hamburg testified before Congress in November that the law was insufficient to enable the FDA to aggressively enforce rules and punish violators, noting that compounding pharmacies mostly are regulated by the states. Republican lawmakers countered that that the agency has authority but fails to use it properly.
Now, it seems, patient safety is the political football in a game between a divided Congress and the FDA. Last week, as reported by ABC News, House Democrats issued a report showing that most states are lax in their oversight of compounding pharmacies, and congressional investigators say state pharmacy boards lack the information and expertise to oversee them.
Of 49 states in the report, only Missouri and Mississippi provided the exact number of compounding pharmacies in their state. They were the only two that require permits or licenses for pharmacies that perform compounding. No state reported having tracked pharmacies that sell compounded drugs across state lines or in large quantities.
Many states, ABC reported, don’t keep inspection records of compounding pharmacies, and 22 don’t keep histories of problems like contamination, cleanliness and drug potency. For some states, record-keeping amounts to a combination of inspection reports, complaints and "staff recollections."
The average pharmacy board has five inspectors to visit all the pharmacies in the state. Only 19 states train inspectors to recognize problems with sterile compounding.
The next day, Republicans issued a report charging that the FDA’s sloth was the problem, not its authority. According to the Associated Press, the GOP said the agency should have closed NECC years earlier, and has always had the authority to do so. And lawmakers on both sides of the aisle called the FDA on carpet for its lack of aggressive action on compounding pharmacies generally.
In her blog, Hamburg said that the FDA has inspected 31 compounding pharmacies considered high risk and found objectionable conditions at 30 of them. Specifically, the FDA was investigating how well the facilities maintained sterile conditions and minimized the risk of contamination. You can read a summary of these inspections here.
In some cases, the feds had to get court warrants because the pharmacies delayed and resisted inspection, and U.S. marshals had to accompany the inspectors. Can you imagine a meat-processing plant engaging in such an act of defiance? An exotic flower importer turning away customs inspectors charged with keeping pests out of the country? And these people claim to be providing products people trust with their lives?
No wonder Hamburg seeks authority and resources for the FDA to police compounding pharmacies nationwide before there are violations, before someone else gets hurt or killed because the people who made their medicine took less care with hygiene than they would changing the fry oil at McDonald’s.