• Modified Senate Legislation Emerges, Would Reform Compounding Regulation, Track and Trace

    The US Senate's Health, Education, Labor and Pensions (HELP) Committee has released an updated version of legislation meant to enact a track and trace system for pharmaceuticals, as well as new regulations to crack down on deficient pharmaceutical compounding practices that resulted in a massive outbreak of fungal meningitis in late 2012. Background Both the Senate and House of Representatives have been working independently of one another to push forward measures on bo...
  • Senate Advances Compounding, Track and Trace Legislation with an Eye on July Passage

    The US Senate's Health, Education, Labor and Pensions (HELP) Committee has advanced two long-sought-after proposals that would overhaul the framework by which the US Food and Drug Administration (FDA) regulates the compounding, tracking and tracing of pharmaceutical products. Pharmaceutical Compounding Both the House and Senate are concurrently working on two sets of proposals: one to change how pharmaceutical compounders are regulated, and one to shore up the pharma...
  • Woodcock: FDA Isn't Fully Aware of Compounding Problem's Scope

    When it comes to pharmaceutical compounding, the US Food and Drug Administration (FDA) knows it has a significant problem on its hands. But as Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), explained to a Senate committee on 9 May 2013, the biggest problem of all may be that FDA has no idea as to the extent of the problem it faces because companies aren't required to report safety problems to it. Background The 9 May hearing was being ...
  • Veterinary User Fee Bills Move Forward in Congress as Approval Appears Likely

    Congressional legislators have nearly cleared a new piece of legislation that would reauthorize the US Food and Drug Administration (FDA) to collect and spend user fees to facilitate and expedite the approval of innovative and generic veterinary pharmaceuticals. Background The bills, the  Animal Drug User Fee Act (ADUFA)  and the  Animal Generic Drug User Fee Act (AGDUFA) , are, like their human prescription drug and medical device counterparts, a me...
  • Legislation Looks to Overhaul Requirements for Presentation, Content of Drug Information

    A new piece of legislation introduced in both the US Senate and House of Representatives last week seeks to make changes to the statutory requirements surrounding the authorship, content, format and dissemination of information about pharmaceuticals. Background: General Drug labeling has been mostly standardized in the US since 1979, when measures to introduce uniformity were first passed. But since that time, the US Food and Drug Administration (FDA) has noted that dru...
  • New Funding Required to Allow FDA to Face 'Brave New World' of Global Supply Chains, Says Hamburg

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg has found herself in front of a congressional hearing for the second time this week, this time under far more favorable circumstances explaining why the agency deserves the funding it receives and-hopefully-more of it. Globalization In prepared testimony delivered on 18 April 2013 to the Senate Committee on Appropriations, the congressional panel with principal authority over FDA's budget, Hamburg obser...
  • FDA Authorized to Spend New User Fees Under Just-Passed Senate Bill

    The US Senate has approved  a measure that would both continue funding government agencies at their currently-appropriated levels and grant the US Food and Drug Administration (FDA) access to user fees it is already authorized to collect, raising the possibility that US regulators will soon be given access to much-needed funding. The bill, known as the continuing resolution (CR), is needed to prevent a potential government shutdown that will otherwise occur at the ...
  • Proposed Senate Bill would Increase FDA Funding by $24 Million, Restore User Fee Funding

    The Senate version of a Continuing Resolution bill that recently passed the US House of Representatives would, like the House version, allow the US Food and Drug Administration (FDA) full access to user fees it now collects from generic pharmaceutical and medical device companies under the 2012 FDA Safety and Innovation Act , as well as some additional appropriated funding. The fees are responsible for partially funding the regulatory agency, which relies on them to be ...
  • Senators Press State Regulators on Compounding Oversight

    • 20 November 2012
    Federal officials may have received the bulk of legislators' ire during two separate hearings on the safety of pharmaceutical compounding products in recent hearings, but now Senate legislators are taking aim at state regulators, asking whether those authorities have adequate resources in place to protect public health. In a letter sent to all 50 state boards of pharmacy on 19 November 2012, bipartisan members of the Senate's Health, Education, Labor and Pensions (HELP...
  • Senate Investigation Claims Medtronic Edited, Influenced Studies

    • 25 October 2012
    A new report released by the Senate Finance Committee slams medical device manufacturer Medtronic for allegedly ghostwriting studies used to support its Infuse Bone Graft system and paying hundreds of millions of dollars to experts who authored company-sponsored studies. The 2,300-page report (PDF, 150 MB) was triggered in part by a 2009 investigation conducted by Med Page Today and the Milwaukee Journal-Sentinel that found the company to have engaged in ghostwri...
  • President Obama Signs into Law Three Bills Affecting FDA

    US President Barack Obama has signed into law three pieces of legislation that affect-directly or indirectly-the activities of the US Food and Drug Administration. User Fees Front and Center The first, and perhaps the most important, bill  was House Joint Resolution 117, the Continuing Appropriations Resolution of 2013 . The bill would maintain funding for US government agencies at fiscal year 2012 levels. While not specifically aimed at FDA, without the legis...
  • Bill to Enhance Fines, Penalties for Falsifying Medical Products Passes Congress

    • 24 September 2012
    A piece of legislation set to increase the amount of fines and severity of penalties for counterfeiters and thieves of medical products has passed both the US House of Representatives and Senate by unanimous consent. The legislation, known at the Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act of 2010 (SAFE DOSES Act ) , was first introduced in March 2012 by Rep. James Sensenbrenner (R-WI). As reported by Regulatory Foc...