An outbreak of fungal meningitis from contaminated steroid injections shipped last May has claimed 45 lives and sickened 693 people. The New England Compounding Center in Framingham, Mass., which sent 17,676 of the adulterated injections to clinics in 23 states, has declared bankruptcy and shuttered its facility. But that is not the end of the story. As Kimberly Kindy, Lena H. Sun and Alice Crites reported in The Washington Post, troubles have run deep for years in the growth of lightly regulated firms that mix and ship medicines to hospitals and clinics known as compounding pharmacies. Some of the firms have expanded to manufacturing scale, yet without adequate protections and quality control.
The Food and Drug Administration already oversees some 25 percent of consumer spending in the United States — a heavy burden. So it is not a trifle when FDA Commissioner Margaret A. Hamburg asks for more to do, but she has so requested in the case of compounding pharmacies.
“We’ve reached a critical point on this issue,” she said. “New, stronger and clearer legislation is necessary to help FDA effectively oversee firms engaged in large-scale distribution of complex compounded products, some of which were highlighted in The Post’s article.”
Traditionally, the licensing and control of pharmacies has been left to the states, but their performance has been uneven. The federal role has been thrown into question in recent years by lawsuits, and the FDA’s enforcement was reactive, not proactive. The FDA does not review the drugs for safety and efficacy, and compounding pharmacies are not generally required to inform the FDA that they are in business nor to register with the FDA or disclose what products they are making. The Post’s investigation showed that 15 companies have come to dominate compounding, and three of them, in addition to the New England Compounding Center, have experienced significant safety problems in the past decade.
Congress needs to give the FDA new tools and enforcement powers. Congress also needs to close a standards gap. The nation’s major pharmaceutical companies must meet Good Manufacturing Practices, a set of strict standards for the production of drugs so that consumers know that each and every dose is correctly formulated and sterile. But these do not apply to compounding pharmacies.
A set of industry standards for compounding was drawn up and published in 2004 but is mandatory in only 17 states and voluntary elsewhere. Congress could make these standards mandatory for all states and all drug compounders, while giving broader authority to the FDA, especially over the larger operations. The states also must remain involved in regulation and enforcement, particularly regarding the smaller pharmacies. The compounding pharmacies meet an important need — they are critical for some small hospitals, for example — and the goal must be to improve safety of their products. The first step is to make sure that they no longer exist in a regulatory twilight zone.
The Washington Post (Feb. 14)