The House Energy & Commerce Committee sent a letter to the International Academy of Compounding Pharmacists (IACP) requesting documents and information after a New York Times article raised questions about IACP’s role in assisting compounding pharmacies in interactions with federal and state authorities, the House committee announced December 7.
According to the October 2012 article, “U.S. Concern Over Compounders Predates Outbreak of Meningitis,” IACP “tutored pharmacists on how to sidestep requests” by FDA for samples to test for quality.
“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,” said the Energy & Commerce letter to IACP.
Documents and information sought in the inquiry include those from January 1, 2002, to the present, and are due to the House committee by December 20, 2012. The two types of documents and information requested are those related to the provision of samples to FDA officials, responses to FDA requests, or FDA inspections of compounding pharmacies; and those containing communications with the New England Compounding Center (NECC), Ameridose LLC, or Alaunus LLC.
In a statement on the IACP website, IACP wrote that it “looks forward to providing all the documentation and information requested by the House Energy & Commerce Committee in their December 6, 2012 request. The New York Times story referenced in the Committee’s request contains significant errors in fact.”
The IACP website statement added that the Times article “has diverted attention away from the cooperative efforts of the Academy in working to prevent a future tragedy” as that caused by the NECC facility linked to the fungal meningitis outbreak, and “the failure of swift and decisive action” by the Massachusetts state board of pharmacy and FDA.
The submitted documents, the IACP statement said, “will not only refute the conclusions conveyed in the Times story but will also include correspondence with their reporters that clearly state the facts of the situation in question.”