Lawmakers want to increase oversight of compounding pharmacies
As many as 13,000 people are believed to have been exposed to a form of fungal meningitis as a result of a tainted batch of spinal steroid injections. As the number of victims has increased, compounding pharmacies, those that create customized versions of medicines, are coming under greater scrutiny, according to the Wall Street Journal.
The U.S. Centers for Disease Control and Prevention reported 105 confirmed cases of fungal meningitis, a rare but often deadly inflammation of brain or central nervous system tissue, in nine states. Eight people died as a result of the illness.
The CDC recently said that the majority of the thousands who may have been exposed to the injections have been contacted and have not fallen ill, but the number of cases could still rise in the coming weeks.
A combination of state regulators, federal agencies and the pharmacy industry share portions of the responsibility for monitoring compounding pharmacies. Health officials, and now lawmakers, believe facilities like the New England Compounding Center, the Massachusetts company that shipped the tainted steroids, are often missed because there is no single body with full responsibility for oversight.
Representative Ed Markey (D-Mass.) recently wrote a letter to U.S. Food and Drug Administration Commissioner Margaret Hamburg criticizing the current disjointed approach.
"Compounding pharmacies currently fall into a regulatory black hole," Markey wrote, the Wall Street Journal reports.