From The Free Press, Mankato, MN
October 30, 2012Our view: Regulate compound pharmacies with care
— So far, 24 people who have died of fungal meningitis after they were injected with tainted steroids made at a compounding pharmacy in Massachusetts. Another 328 people in 18 states have fallen ill, including nine in Minnesota.
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 didn’t come under the same regulation as large drug makers who 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.
Congress will need to find ways to rein in so-called 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.
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 didn’t come under the same regulation as large drug makers who 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.
Congress will need to find ways to rein in so-called 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.
Source found here
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