February 19, 2013

Another View: Stronger regulation needed for compounding pharmacies

The Food and Drug Administration does not have the tools it needs to keep us safe.

The Washington Post

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 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."

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.


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