Dingell Questions FDA’s Authority to Oversee Compounding Pharmacies

Washington, D.C.  –  Today Congressman John D. Dingell (D-MI15) participated in a House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations hearing on the recent fungal meningitis outbreak plaguing our country.   Appearing before the Subcommittee was Ms. Joyce Lovelace, the wife of a meningitis victim; Mr. Barry Cadden, President, Co-Owner, and Director of Pharmacy at the New England Compounding Center (NECC); the Honorable Margaret A. Hamburg, M.D., Commissioner of the U.S. Food and Drug Administration (FDA); and, Dr. Lauren Smith, Interim Commissioner of the Massachusetts Department of Public Health.  This morning’s questioning came on the heels of Congressman Dingell’s urging that the Committee hold a hearing in order to examine current policy issues surrounding this crisis.

“It is clear that the New England Compounding Center, which has had a long history of sterility issues, was not properly regulated by federal or state authorities.  It is further clear that NECC blatantly chose not to address deficiencies and violations found by FDA and the Massachusetts Board of Pharmacy, and additionally compounded these steroids without patient-specific prescriptions as required by Massachusetts state law.  The individuals who have been infected and their families deserve answers as to how this was able to happen,” Dingell stated.

“While I recognize that compounding serves an important public health purpose, I am concerned that NECC was operating at such a volume to be outside of what may be considered traditional pharmacy compounding and may instead be classified as drug manufacturing.  I hope, and I intend, to work with my colleagues on both sides of the aisle to find out how FDA can address the issue before us with existing regulatory authority and what additional statutory authority may be needed to prevent a future outbreak like the one we are suffering now.”

Congressman Dingell sent two letters to the FDA last month; the first calling for further investigation of NECC and the second regarding the Congressman’s concern that additional contaminated drugs were being used in hospital and clinics.  The State of Michigan leads the country in number of cases related to this fungal meningitis outbreak with 148 patients infected and eight deaths.  The victims of fungal meningitis are being treated in Congressman Dingell’s district at St. Joseph Mercy Ann Arbor hospital.  Nationally, there have been 438 patients infected and 32 deaths in 19 states.  Mr. Dingell will continue to remain vigilant and work with authorities at the FDA to ensure no more lives will be lost due to this preventable outbreak. 

Further information about the hearing, including written testimony, can be found here.

To watch Congressman Dingell’s questions of Commissioner Hamburg, please click here.

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