Excerpt: HHS has failed to issue even one of these annual reports required by law during the nearly four years you have been Secretary. It also means that the 2009 annual report is now more than 1,000 days overdue. To read the letter, click here.
Excerpt: While we are disappointed that neither you nor anyone else from the NECC could make themselves available to brief committee staff, the committee must proceed with the investigation. We expect that you will cooperate in this matter. To read the letter to Barry Cadden, click here.
Excerpt: 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.
Excerpt: The committee is investigating whether any remedial measures were taken after this inspection and why the NECC was able to continue operating in this manner more than six years after the fact... To assist the committee in better understanding the NECC’s operations, as well any actions taken by the Board of Pharmacy to address potential violations, we ask that you make arrangements with Committee staff to schedule a briefing on these matters to occur no later than October 19, 2012
Letter to the New England Compounding Center Requesting Bipartisan Briefing on Fungal Meningitis OutbreakOctober 11, 2012 | Letter
Excerpt: We will be meeting with FDA, CDC and others that may provide insight into the details surrounding this outbreak and the prevention of future outbreaks. Given this continued interest, we ask that you preserve all documents and communications that may be relevant to understanding how the product was contaminated and distributed as well as the business practices of the NECC in general.
Excerpt: Lawmakers in both chambers of Congress and on both sides of the aisle agree that cybersecurity is of critical importance to America’s safety and prosperity in the 21st century. The House of Representatives has already passed the Cyber Intelligence Sharing and Protection Act (CISPA) to bring the nation’s considerable wealth of public and private sector intelligence to bear on the challenge of securing America’s vital communications networks.