It is crucial for Americans to have confidence that the medications they take are safe. Thanks to rigorous oversight by the U.S. Food and Drug Administration, that’s mostly the case.But one segment of the pharmaceutical industry has been carved out of the FDA inspection process. Compounding pharmacies, which create customized medications from scratch, are regulated by state boards, and sometimes not closely enough. Most are professionally run operations that serve an essential role in medicine. But as two recent incidents have proved, it is too easy for rogue drug manufacturers to exploit an oversight vacuum and jeopardize patients’ safety.
An outbreak of deadly fungal infections identified in September was traced to the New England Compounding Center in Massachusetts. Regulators said the place was operating more like a drug manufacturer than a traditional compound pharmacy, which works with physicians to produce small quantities of medications. The contaminated drugs that were mass produced by the Massachusetts firm sickened more than 700 persons and killed 58 others.
More recently, illnesses in four states have been linked to the Main Street Family Pharmacy in Tennessee. Regulators have cited the operators with multiple violations, including the discovery of spiders in the “clean room” where sterile drugs are compounded.
This risky behavior must end. Fortunately, a bipartisan group in the U.S. Senate, which includes Kansas Sen. Pat Roberts, is moving forward with legislation intended to crack down on abuses while preserving enough flexibility for smaller pharmaceutical compounders to respond quickly to specialized needs and prescriptions.
Under a bill that may be brought before the full Senate this summer, compounding operations would fall under FDA authority if they ship sterile medications across state lines without or in advance of prescriptions. This makes sense. The federal agency has a full apparatus in place to inspect and regulate drug manufacturers.
The bill keeps the regulatory authority for small, neighborhood compounding pharmacies with the states.
The legislation, which passed the Senate Health, Education, Labor and Pensions Committee in May, isn’t perfect. It would enable large compounding pharmacies to avoid FDA oversight if they confined their sales to a single state. A stipulation that the FDA regulate sterile drugs, while states have oversight over non-sterile medications, seems overly complicated.
Given the resistance to any increased oversight of compounding pharmacies, though, this bill is a good start. It will be a travesty if resistance from the drug compounding industry succeeds in killing or fatally weakening the effort.
Whatever happens in Congress, it is important that states maintain vigilant oversight. Robert Courtney, the Kansas City area pharmacist who is serving prison time for diluting cancer drugs, would have fallen under state jurisdiction under the terms of the proposed legislation.
Quoted from here