• After Numerous Delays, Legislation to Curb Drug Shortages to Advance in Congress

    • 11 May 2012
    In early 2011, several bills aiming to curb drug shortages were introduced in the US House of Representatives and the US Senate. Despite the bills' bipartisan nature and widespread support, they've languished in Congressional committees ever since. Now, reports CBS , there are signs that both bills could see passage before the end of the year. The bills, House and Senate versions of the Preserving Access to Life-Saving Medications Act (H.R. 2245 & S. 296) , would r...
  • Hamburg Touts Agency's Efforts to Curb Drug Shortages

    • 04 May 2012
    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg said her agency has been remarkably successful in curbing drug shortages and working with industry to provide advanced warning when the agency is unable to prevent a shortage. In a posting on the agency's FDA Voice blog, Hamburg said she is "both amazed and delighted to see the progress that's been made." Hamburg noted advanced warning of shortages-thanks in part to an FDA rule asking manufacturers to...
  • Hamburg Touts FDA's Promotion of a 'Robust Field of Regulatory Science' in Speech

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg touted her agency's efforts to advance and promote a 'robust field of regulatory science' in a speech before a NEHI Conference. Calling regulatory science "important," Hamburg laid out some of what FDA has managed to accomplish in the last few years, including the establishment of three Centers of Excellence in Regulatory Science, working to get the Reagan-Udall Foundation up and running and the format...
  • FDA Employees Shed Insight on Agency's Activities, Goals

    Employees of the US Food and Drug Administration (FDA) have had a busy week (23-27 April), speaking at a wide range of events and venues. Regulatory Focus is happy to bring you a brief recap of their remarks in one centralized location. Margaret Hamburg, Commissioner, FDA : Hamburg said at a conference this week she experts this year to be "a landmark year" for legislative improvements to FDA's authority, but said it remains "difficult to predict" what form l...
  • Report: 'Track and Trace' Anti-Counterfeiting Provisions Likely Casualty of User Fee Markup

    • 25 April 2012
    A long-awaited and much-called-for plan to introduce a 'track and trace' plan to cut down on pharmaceutical counterfeiting may be cast by the wayside in the legislative markup process for new legislation, reports Reuters ' AlertNet . Track and trace programs, used by regulatory authorities to keep track of authentic drugs and trace their transmission through the supply chain, have been receiving increased attention in recent years. The US Food and Drug Administrati...
  • FDA Report: Agency Moving to Engage Globally to Meet Realities of Supply Chain

    The US Food and Drug Administration (FDA) Commissioner Margaret Hamburg released a new report that aims to show how the regulatory agency is revamping itself from a domestic agency to one with a "global public health focus". "As our world transforms and becomes increasingly globalized, we must come together in new, unprecedented, even unexpected, ways to build a public health safety net for consumers around the world," said Hamburg in a statement. FDA's Global Engageme...
  • Hamburg: Nanotechnology Regulation Likely to Become 'More Nuanced,' Outlines Regulatory Approach

    • 23 April 2012
    After releasing new nanotechnology standards for food and cosmetic products, US Food and Drug Administration (FDA) Commissioner Margaret Hamburg says the agency's approach to the regulation of nanotechnology products is likely to become "more nuanced" over time. Writing in the journal Science , Hamburg writes the agency has "long encountered the combination of promise, risk, and uncertainty that accompanies emerging technologies." "Nanotechnology is not unique in thi...
  • After Counterfeit Avastin Infiltrates Supply Chain, FDA Goes After Doctors

    The US Food and Drug Administration (FDA) is going after doctors in an attempt to protect the pharmaceutical supply chain from more instances of counterfeit medicines, reports Medscape News . There have been two instances of fake Avastin being found in the US in 2012-one in early April and another in mid-February . Both cases involved doctors deviating from approved suppliers to purchase Avastin from unauthorized wholesalers. While FDA Commissioner Margaret Hamburg ...
  • Hamburg: 'I Understand the Frustration' With Inefficient Regulations

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg spoke at the International Conference on Emerging Infectious Diseases, saying the agency is aware of the "dearth of new products" in the development pipeline to fight infectious diseases, and is doing everything it can to open up new and innovative regulatory pathways to speed products to market. The 11 March keynote speech by Hamburg-herself a former commissioner of health and physician-focused primaril...
  • FDA Seeks to Limit Antibiotics in Animal Feed

    The Food and Drug Administration has released guidance asking drug companies to voluntarily limit the use of certain antibiotics in animal feed in response to concerns that their overuse in livestock contributes to the development of drug-resistant bacteria.  "It is critical that we take action to protect public health," said FDA Commissioner Margaret A. Hamburg, MD. The agency has published three documents to address the issue: (1) A final guidance that...
  • FDA Gets New COO

    Biocentury reports US Food and Drug Administration (FDA) Commissioner Margaret Hamburg has tapped Walter Harris, currently at the Centers for Disease Control and Prevention (CDC), to be FDA's new Chief Operating Officer (COO). At CDC, Harris served as both the Chief Human Capital and Resources Officer and the Deputy Director of the Office of Surveillance, Epidemiology and Laboratory Services (OSELS). Before arriving at CDC, Harris served as Acting Chief Information Off...
  • Congressmen Pressure FDA, FCC Over Wireless Health Regulation

    A group of six Republican Representatives sent the Commissioners of the US Food and Drug Administration (FDA) and the Federal Communications Commission (FCC) a letter cautioning the agencies against issuing "slow and inconsistent regulations," reports Mobi Health News . "These new technologies increasingly cross two regulatory structures," the Congressmen state in the letter. "It is critical that the two agencies act in concert to provide regulatory predictability, cons...