Committee Leaders Request Documents from Drug Compounding Industry Association
House Energy and Commerce Committee leaders sent a letter today 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. Henry A. Waxman, Fred Upton, Diana DeGette, Cliff Stearns, Frank Pallone, Jr., Joseph Pitts, John D. Dingell, Joe Barton, Edward Markey, and Michael C. Burgess, M.D.
The full text of the letter is below and is also available online here.
December 7, 2012
Mr. Scott Karolchyk
President
Board of Directors
International Academy of Compounding Pharmacists
4638 Riverstone Blvd.
Missouri City, TX 77459
Dear Mr. Karolchyk:
Pursuant to Rules X and XI of the U.S. House of Representatives, the Committee on Energy and Commerce is investigating the facts surrounding the recent outbreak of fungal meningitis linked to contaminated steroids made and distributed by the New England Compounding Center (NECC).
According to an October 2012 New York Times report, the International Academy of Compounding Pharmacists “tutored pharmacists on how to sidestep [U.S. Ford and Drug Administration] requests” for samples related to FDA’s assessment of the quality of compounded drugs. Specifically, the Times stated that your association told its members: “We do not compound or distribute ‘samples’ of any of our prescription medications to anyone. And if a compounded drug was on the premises…a pharmacist should say it was awaiting pickup by a patient.” 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.
To assist the Committee in understanding your role in assisting compounding pharmacists in their interactions with Federal and State authorities, please provide the following documents and information, from January 1, 2002, to the present, by no later than December 20, 2012:
1. All documents, including internal communications and communications to your members, 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.
2. All documents containing communications with any owners, pharmacists, or employees of the New England Compounding Center (NECC), Ameridose, LLC; or Alaunus, LLC, including, but not limited to, Barry J. Cadden.
An attachment to this letter provides additional information about how to respond to the Committee’s request. Should you have any question, please contact John Stone or Brian Cohen with the Committee staff at (202) 225-2927.
Sincerely,
Fred Upton
Chairman
Henry A. Waxman
Ranking Member
Cliff Stearns
Chairman
Subcommittee on Oversight and Investigations
Diane DeGette
Ranking Member
Subcommittee on Oversight and Investigations
Joseph Pitts
Chairman
Subcommittee on Health
Frank Pallone, Jr.
Ranking Member
Subcommittee on Health
Joe Barton
Chairman Emeritus
John D. Dingell
Chairman Emeritus
Michael C. Burgess
Vice Chairman
Subcommittee on Health
Edward Markey
Member
Subcommittee on Oversight and Investigations
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