Compounding pharmacies continue to face intense scrutiny over their drug preparation and lobbying habits after one in Massachusetts is suspected in distributing a steroid that led to a meningitis outbreak.
The Wall Street Journal: Pharmacies Fought Controls
How these firms escaped closer regulation shows how little happens in Washington absent an emergency. Top lawmakers and federal officials tried for years to increase regulation. A countereffort by the industry and a series of court decisions helped beat that back. Federal agencies debated about who should crack down on the industry. Lawmakers eventually abandoned their push after deciding the issue wasn't important enough (Burton, Grimaldi and Martin, 10/14).
The Boston Globe: A Close Look At Compounding Pharmacies
The New England Compounding Center, the pharmacy implicated in the infections, was apparently preparing drugs for bulk, nationwide distribution, raising questions about why it was not licensed and held to the standards of a manufacturer. But such broad distribution is not what most compounding pharmacies are set up to do. Instead, they predominantly serve a limited geographic region -- filling individual prescriptions for patients and often developing specialties based on the needs of their clients, pharmacists say (Johnson and Lazar, 10/15).
MPR: Pharmacies Under Scrutiny As Meningitis Outbreak Spreads
From a window positioned over his desk, longtime pharmacist Gary Carlson has a bird's-eye view of lab workers filling IV bags in the sterile production line of Fairview Compounding Pharmacy. At its busiest the Minneapolis facility can manufacture as many as 20,000 doses in a month of its most popular sterile drug, which it then distributes among the medical system's six hospitals and about 40 clinics (Benson, 10/15).
CQ HealthBeat: Energy And Commerce Opens Bipartisan Probe Of Fungal Meningitis Outbreak
Congressional interest in the chain of events that led to an outbreak of fungal meningitis is growing, with bipartisan leaders of the House Energy and Commerce Committee requesting a briefing with the owners of the compounding pharmacy at the center of the outbreak. They also wrote Friday to the Massachusetts Board of Registration in Pharmacy asking whether any action was taken after a 2004 inspection of the pharmacy by the state and the Food and Drug Administration found "significant violations" witnessed by investigators (Norman, 10/12).