WASHINGTON, Dec 7 (Reuters) - A U.S. congressional committee that oversees drug safety issues has asked a compounding pharmacists’ industry association to provide documents on the group’s role in helping pharmacies in their interactions with federal and state authorities.
The request to the International Academy of Compounding Pharmacists came as the House Energy and Commerce Committee continues an investigation into a deadly meningitis outbreak caused by contaminated compounded drugs.
In a letter released on Friday, 10 lawmakers cited a media report that the group “tutored pharmacists on how to sidestep” U.S. Food and Drug Administration requests for samples that would help the agency assess the quality of compounded drugs.
“Allegations that your association may have encouraged compounding pharmacists to attempt to impede the FDA from evaluating the efficacy and safety of their products, if true, raise serious concerns,” the lawmakers said.
The meningitis outbreak, linked to steroid injections from the Massachusetts-based New England Compounding Center, has sickened 541 people, 36 of whom have died, according to the U.S. Centers for Disease Control and Prevention.