Energy and Commerce Leaders Seek All Documents Related to FDA’s Oversight of the NECC Dating Back to 2004

October 17, 2012

WASHINGTON, DC – House Energy and Commerce Committee leaders today requested additional information from the Food and Drug Administration regarding its oversight of the New England Compounding Center in Framingham, Massachusetts, which has been linked to the recent outbreak of fungal meningitis. In December 2006, the FDA sent a warning letter detailing a list of significant violations of the Food, Drug, and Cosmetic Act. Included in the list of violations was the NECC’s manipulation of a sterile injectable product. Members have requested a full history of the FDA’s oversight of the NECC to better understand its knowledge of the operations and whether subsequent inspections were conducted after the initial warning letter.

The members wrote, “FDA’s warning letter informed NECC that ‘[f]ailure to promptly correct these deviations may result in additional regulatory action without further notice, including seizure and injunction against you and your firm.’ During initial discussions with committee staff on October 12, 2012, FDA officials said that the NECC responded about a month after the warning letter assuring regulators that the firm was in compliance with good compounding practices. At the time of this briefing, FDA officials could not confirm whether any subsequent inspections were conducted to validate that the FDCA violations were corrected. During the briefing, FDA committed to providing the committee with additional details regarding past interactions with the NECC.”

Last week, the bipartisan committee leaders requested documents from the Massachusetts Board of Registration in Pharmacy and also requested a briefing from the NECC.