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.
Excerpt: The Committee shares the goals of the Commission to ensure the nation’s energy infrastructure is protected from physical and cyber threats and we look forward to learning more about the objectives of the OEIS. To read the letter, click here.
Excerpt: The federal government currently supports energy-related technologies, projects, and companies through various forms of federal assistance, including grants, direct loans, loan guarantees, and a range of available tax credits. Federal dollars also are used to advance programmatic activities, such as implementation of the federal energy mandates.