Subcommittee on Oversight and Investigations Committee on Energy and Commerce Letter to Chairman Tim Murphy from Henry Waxman With Numerous Supporting Documents Attached and Linked

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]