House lawmakers are investigating whether the industry group for compounding pharmacies coached the company responsible for a deadly outbreak of meningitis in dealing with regulators.
The House Committee on Energy and Commerce sent a letter Friday to the International Academy of Compounding Pharmacists requesting any documents it distributed to members about how to respond to state and federal health inspectors.
"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," states the letter, signed by Republican and Democratic committee leaders.
The lawmakers are investigating the outbreak linked to contaminated pain injections from the New England Compounding Center, which has sickened more than 540 people and killed 36. About 300 of the cases were caused by a rare form of fungal meningitis. Other fungal infections accounted for the rest.
The compounding group said in a statement it would provide documents that disprove the allegations, which it described as a diversion.
"It has diverted attention away from the cooperative efforts of the academy in working to prevent a future tragedy as that caused by NECC and the failure of swift and decisive action by the Massachusetts Board of Registration in Pharmacy and the federal Food and Drug Administration," the group said in a statement.
Compounding pharmacies, which mix customized medications based on doctors' instructions, are traditionally overseen by state pharmacy boards. But some House members have introduced legislation that would give the FDA a greater role in regulating compounders, in light of the recent outbreak.
The International Academy of Compounding Pharmacists has opposed multiple attempts to increased federal oversight dating back to the 1990s. In testimony last month before Congress, the group's CEO said that the NECC could have been shut down under existing laws.
Based in Missouri City, Texas, the group has spent more than $1 million lobbying Congress in the past decade, according to data from the Center for Responsive Politics.
Health officials say roughly 14,000 U.S. patients received the steroid shots from the Massachusetts-based NECC, mostly for back pain. The Centers for Disease Control later showed that at least two lots of the injections distributed to 23 states were contaminated with fungus.