Committee Leaders Request Documents from Drug Compounding Industry Association
WASHINGTON, DC –House Energy and Commerce Committee leaders sent a letter to the International Academy of Compounding Pharmacists seeking information on the role of this industry association in assisting compounding pharmacies in their interactions with federal and state authorities. A bipartisan group of committee leaders wrote, “Allegations that your association may have encouraged compounding pharmacists to attempt to impede FDA from evaluating the efficacy and safety of their products, if true, raise serious concerns about your actions.”
The committee, conducting an ongoing bipartisan investigation of the deadly meningitis outbreak caused by contaminated compounded drugs from the New England Compounding Center (NECC), asked for documents directly related to NECC, and for materials “referring or relating to the provision of samples to FDA officials; responding to FDA requests for records or other materials or information; or FDA inspections of compounding pharmacies.”
The letter was signed by Reps. Fred Upton, Henry A. Waxman, Cliff Stearns, Diana DeGette, Joseph Pitts, Frank Pallone, Jr., Joe Barton, John D. Dingell, Michael C. Burgess, M.D., and Edward Markey.
The full text of the letter is available here.