---- — So far, 32 people have died of fungal meningitis after they were injected with tainted steroids made at a compounding pharmacy here in Massachusetts. Another 438 people in 18 states have fallen ill.
What those patients didn’t know is that the pharmacy that made the steroids and others like it have been largely exempted from Food and Drug Administration oversight.
More FDA oversight in the specialty businesses is needed, but it should be done in a way that does not bring onerous regulation to the many small compounding pharmacies that provide a valuable service for patients and doctors.
Most of the compounding pharmacies are small operations that custom-mix drugs, such as specific compounds to treat children or seniors who can’t easily swallow pills.
The small, specialized industry doesn’t come under the same regulation as large drug makers that must ensure they’re operating sterile facilities in a safe manner.
But some compounding pharmacies have grown into mega-drug manufacturers that are pushing the legal limits.
An FDA official warned in 2003 that some large compounders were using “creative marketing” to sell drugs they claimed were superior, without any evidence of support. Still others were manufacturing drugs they claimed were unique, when they were in fact simply cheaper versions of existing drugs.
Regulation of compounding pharmacies has been left to the states, with some assuming that role well, while others are unprepared to provide real oversight.
That may have been the case in Massachusetts, where state pharmacy regulators at least twice were indifferent to reports of concerns with the operations of the New England Compounding Center in Framingham, according to a story in the Boston Globe.
Beginning in 2002, state and federal regulators were investigating New England Compounding over problems with an injectable steroid made by the company. The company’s lead pharmacist and co-owner, Barry Cadden, initially cooperated with the probe but then stopped answering questions, the Globe reported.
Even as this investigation was proceeding, state regulators invited Cadden to sit on a task force writing rules to govern the compounding industry, the Globe reported.
The proposed regulations written by the task force came under fire from the industry, were softened, and ultimately never implemented.
Compounding pharmacies provide a vital service in the medical field, producing speciality medicines in quantities too small to attract the interest of big pharmaceutical manufacturers.
In Washington, committees in both the House and Senate are holding hearings on the meningitis outbreak that has been linked to the pharmacy. Legislators are vowing to crack down with new federal regulations on the compounding industry. But industry officials are insisting that regulation of their operations should remain with the states.
Congress will need to find ways to rein in compounding pharmacies that are operating in an unsafe manner. But they and the FDA must also be careful not to put needless and costly regulations on legitimate smaller operations.
A careful balance is needed here, one that addresses concerns about patient safety without killing an industry that fulfills an important medical need.