Apr 11, 2013
Today Reps. Henry A. Waxman, Diana DeGette, John
D. Dingell, and Edward J. Markey sent a letter to Oversight and
Investigations Subcommittee Chairman Tim Murphy urging him to invite the
head of the International Academy of Compounding Pharmacists (IACP) to
testify at the Committee’s April 16 hearing on the recent meningitis
outbreak.
The members write that “the information contained in IACP’s documents helps explain why FDA would have had difficulty acting to regulate compounding pharmacies. Most importantly, the documents show why legislation that gives FDA clear authority to regulate compounding pharmacies is now necessary.”
The Committee will be holding its second hearing into the deadly meningitis outbreak caused by contaminated injectable drugs on Tuesday, April 16, 2013.
The full text of the letter and supporting documents are available below.
April 11, 2013
The Honorable Tim Murphy
Chairman
Subcommittee on Oversight and Investigations
Committee on Energy and Commerce
2125 Rayburn House Office Building
Washington, D.C. 20515
Dear Chairman Murphy:
Next week, the Subcommittee will be holding our second hearing into the deadly meningitis outbreak caused by contaminated injectable drugs from the New England Compounding Center (NECC). You have invited Margaret Hamburg, the Food and Drug Administration (FDA) Commissioner to testify at this hearing. We think you should also invite the head of the International Academy of Compounding Pharmacists (IACP), the national organization representing compounding pharmacists.
A key question for this hearing is why FDA has not acted more forcefully to protect the public from the risks of improperly compounded drugs. At our November hearing, Commissioner Hamburg indicated that weak legislative authority, combined with a series of conflicting court decisions that caused uncertainty as to the validity of the authorizing statute itself, left the agency without adequate authority to act against drug compounders.[1]
Documents provided to the Committee by IACP substantiate Commissioner Hamburg’s testimony. These documents reveal that for almost two decades, IACP lobbied aggressively and successfully to restrict FDA authority over compounding pharmacies. Even when individuals at the organization’s highest levels were aware of significant public health risks from compounding, IACP acted to prevent effective FDA oversight.
IACP’s past efforts and statements stand in sharp contrast to the organization’s recent statements that FDA’s authority in this area is “clear, direct, and certain.”[2] The information contained in IACP’s documents helps explain why FDA would have had difficulty acting to regulate compounding pharmacies. Most importantly, the documents show why legislation that gives FDA clear authority to regulate compounding pharmacies is now necessary.
We are thus requesting that you invite a representative from IACP to the April 16 hearing so we can understand the organization’s past actions and current views on FDA authority over compounding pharmacies.
Introduction
In September 2012, officials in Tennessee identified the
first of hundreds of cases of fungal meningitis in patients who had
received contaminated injectable products made and distributed by a
Massachusetts based drug compounder. To date, 733 individuals have
contracted fungal meningitis, and 53 have died from injections of
preservative-free methylprednisolone acetate compounded by the New
England Compounding Center.[3]
Prior to this incident, both the Massachusetts State Board of Pharmacy
and FDA had inspected the facility and identified numerous issues with
its procedures and practices. Despite this history, the drug
compounding company was allowed to continue to distribute products
without significant disruption.On November 14, 2012, the Committee on Energy and Commerce’s Subcommittee on Oversight and Investigations held a hearing on the fungal meningitis outbreak.[4] During the hearing, FDA Commissioner Dr. Margaret Hamburg stated that FDA’s ability to regulate and oversee compounding facilities, like NECC, was often limited because legal decisions had created “enormous lack of clarity” regarding FDA’s authority over drug compounding.
On December 7, 2012, members of the Committee sent a letter to IACP requesting information on allegations that IACP “tutored pharmacists on how to sidestep [FDA] requests” for samples related to the agency’s assessment of the quality of compounded drugs.[5] In response, IACP briefed Committee staff on these allegations and provided over 3,000 pages of documents relating to their work on behalf of their member pharmacies. Committee investigators reviewed the documents provided to the Committee by IACP. They also reviewed public statements by IACP and its member drug compounding companies and legal and regulatory filings submitted by these organizations. These documents reveal that for almost two decades, IACP has aggressively acted to limit FDA authority over compounding pharmacies.
IACP’s Efforts to Block FDA Regulation of Compounding Pharmacies
One IACP document, an undated internal history entitled
“Compounders on Capitol Hill,” describes efforts beginning in 1995 to
“enact legislation to protect our right to compound.”[6]
This legislation ultimately was incorporated into the Food and Drug
Administration Modernization Act of 1997 (FDAMA), which FDA has
identified as a key reason the agency’s authority is uncertain. The
same IACP internal history reveals that in 1999, almost immediately
after FDA commenced implementing this new law, IACP began to lobby
Congress to further rein in the agency, citing FDA “overreach” in
efforts to address limits on drug compounders.[7]Source found here