From an editorial published in the New York Times on Tuesday:
The meningitis outbreak that has sickened at least 119 people and killed 11 of them has laid bare a disturbing lack of regulatory oversight of pharmacies that mix drug compounds and ship them around the country. Unless Congress passes legislation to strengthen the hand of the Food and Drug Administration, the public will continue to be at risk from contaminated products.
The outbreak has been linked to a steroid made by the New England Compounding Center in Framingham, Mass., that was shipped to 23 states [including North Carolina]. The steroid was almost certainly contaminated by a fungus, although final laboratory results are not yet in. Some 13,000 patients may have had the tainted steroid injected near their spines to ease back or neck pain. The center has shut down, surrendered its license and recalled all of its products while state and federal investigations try to pin down exactly what went wrong.
How could this happen? As Denise Grady, Andrew Pollack and Sabrina Tavernise explained in The Times, these pharmacies fall into a legal no man’s land between the Food and Drug Administration and 50 state pharmacy boards, most of which have little expertise and limited resources to ensure the safety of these products.
Years ago, compounding pharmacies were small-scale operations. Over the past decade or more, however, some pharmacies have morphed into miniature drug companies. Doctors and hospitals have turned to these pharmacies because their prices are often much lower than those charged by major manufacturers or because the standard drugs are in short supply. Therein lies an element of risk. Compounded drugs have not gone through the same rigorous tests for safety and effectiveness required of standard drugs. There have been several incidents in recent years in which compounded drugs have caused injury. Some critics complain that the FDA and state regulators should have intervened in this case sooner and more forcefully, which may well be true. But conflicting court decisions have left unclear what powers the FDA has to regulate these pharmacies.
Congress should clarify matters with legislation. The legislation ought to grant the FDA any powers it thinks it needs to inspect compounding pharmacies, monitor their nationwide sales and judge the safety or effectiveness of their products.
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