Questions continue over state, FDA oversight of specialty pharmacies

Nov 21 2012

Several news outlets analyze the hearings last week into the meningitis outbreak resulting from a New England compounding pharmacy.

The Associated Press/Boston Globe: Senate Questions Pharmacy Boards After Outbreak
A Senate committee investigating the deadly outbreak of meningitis wants to know how regulators in all 50 states oversee specialty pharmacies like the one that triggered the illness. The Senate Committee on Health, Education, Labor and Pensions sent letters Monday to all 50 state boards of pharmacy, seeking details about their oversight of compounding pharmacies (Perrone, 11/19).

The New York Times: Deaths Stir A Dispute On Powers Of FDA
The issue is that New England Compounding identified itself as a compounding pharmacy, a practice that is supposed to involve making unusual drug formulations to fill prescriptions for individual patients with special needs. Compounding is legal on a small scale, and does not have to follow the strict rules that apply to mass-produced drugs. It is generally regulated by states rather than the federal government, which has jurisdiction over manufacturers (Grady, 11/19).

Reuters: Amid Meningitis Crisis, Critics Say Medicare May Promote Risky Drug Compounding
As long as a physician has prescribed a compounded drug, Medicare as well as some private insurers cover it even if the Food and Drug Administration has approved a version of the drug from a pharmaceutical manufacturer. ... HHS spokesman told Reuters that if the FDA finds that a company is producing compounded drugs in violation of the law, "Medicare will not reimburse for drugs produced in that facility." But because the FDA's authority over compounding pharmacies is severely limited, "we urge Congress to strengthen FDA's authority" (Begley, 11/19).