A federal investigation into a deadly multistate fungal meningitis outbreak has widened to the entire compounding pharmaceutical industry. Modern Health Care Magazine reports that the House Energy and Commerce Committee recently sent a letter to the compounding pharmacy trade group requesting more information and accusing the group of stonewalling federal investigations into potentially defective pharmaceuticals.
The Dec. 7 letter to the International Academy of Compounding Pharmacists cites a New York Times report alleging that the group taught pharmacists “how to sidestep FDA requests for samples related to the FDA’s assessment of the quality of compounded drugs.”
The NYT article alleged that the group told pharmacists not to distribute their drugs to regulators and to falsely claim that already-made compounded drugs were awaiting patient pickup.
“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 about your actions,” the lawmakers said.
This is part of a widening realization among lawmakers that compounding pharmacies have been operating in ways which may endanger patient safety.
Recently the Massachusetts Department of Public Health shut down three other compounding pharmacies which were found to have inadequate safety and sanitation guards in place.