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  • US Congress Takes Interest in Regulatory Process with Flurry of Laws not Seen Since Early 2000s

    Have pity on the regulatory professional. Even under normal circumstances, the job of a regulatory professional-both those in government and in industry-is notoriously difficult, with long hours and highly complex and regulated material to work through. But even as pipelines have dried up and the stakes of regulatory approval have increased, regulators are dealing with one other challenge that has mostly flown under the radar: a parade of new legislative requirements. ...
  • House Legislators Set to Grill FDA on FDASIA Progress

    It's been more than a year since legislators passed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law, and now those same legislators want to know: How is the law doing? Background: FDASIA's User Fee Provisions FDASIA , passed in July 2012, contains provisions that can generally be lumped into two broad categories: user fee programs and reforms. To the former (Titles I-IV), FDASIA reauthorized two major user fee programs, the Prescripti...
  • House Version of Compounding Legislation Emerges, Contrasting Sharply With Senate Approach

    Several prominent members of the House of Representatives' Energy and Commerce (E&C) Committee have released the text of new legislation intended to better regulate the pharmaceutical compounding industry in the wake of a deadly outbreak of fungal meningitis in 2012. Background: Compounding In the waning months of 2012, a massive outbreak of fungal meningitis was linked to supposedly sterile versions of methylprednisone acetate manufactured by the New England Compou...
  • Legislators Move to Close Loophole Affecting Sanofi's New Influenza Vaccine

    When the US Food and Drug Administration (FDA) approved a new four-strain flu vaccine manufactured by French life sciences manufacturer Sanofi in early June 2013, it didn't just mark a momentous occasion for regulatory officials within Sanofi - it also exposed a potential loophole in how US officials accommodate the safety of vaccine products, one legislators are now eager to fix. Background The problem uncovered doesn't have to do with the safety of Sanofi's quadrivale...
  • FDA Funding Set to Increase in 2014 after Year of Cutbacks

    US healthcare product regulators stand to get a sizable boost in their funding during the next fiscal year if the House Appropriations Committee gets its way. The Committee's Agriculture Appropriations Subcommittee, which has budget authority over the US Food and Drug Administration, met on 5 June 2013 to mark-up the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations bill, which would set FDA's funding for the 2014 fiscal ...
  • Brazilian House Holds Hearing on Anvisa Regulatory Authority

    The Committee on Social Security and Family of Brazil's House of Representatives held a hearing on 9 May 2013 on the scope of regulatory authority of Brazil's National Health Surveillance Agency (Anvisa) with one question in mind: Does Anvisa have too much regulatory authority? The deputy director of Anvisa, Neilton Araújo, argued that several bills introduced in the Brazilian Congress to cut back the agency's regulatory authority would in fact be a setback for ...
  • Legislators Fire off Letters to FDA, Industry Seeking Information about 'Illegal' Supplement

    The US Food and Drug Administration (FDA) often finds itself in the firing line of US legislators. The reasons vary-unsafe drugs, a deficient supply chain, too much regulatory activity, too little regulatory activity, and seemingly everything in between. But one area has been relatively free from congressional interference in recent years: Dietary supplements. That is, until now. In a series of letters sent to FDA regulators and several companies on 8 May 2013, Republica...
  • 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...
  • Legislators, FDA Outline Cases in Advance of Major Hearing on Pharmaceutical Compounding

    Legislators and regulators alike have released previews of the arguments they intend to make at an upcoming hearing regarding a massive outbreak of fungal meningitis caused by deficient compounding practices at a Massachusetts facility, indicating that Tuesday's hearing could-once again-be a contentious one. Background Pharmaceutical compounding pharmacies enjoy a relatively unusual regulatory exemption in the US whereby they can compound products without having first s...
  • Hamburg to be Hauled before House Committee again to Address Agency's Compounding Culpability

    Top officials with the US Food and Drug Administration (FDA) will against find themselves in the firing line of congressional legislators in the coming week as the House Energy and Commerce Committee says it's not finished probing the agency's response to a recent outbreak of fungal meningitis. Background Pharmaceutical compounding pharmacies enjoy a relatively unusual regulatory exemption in the US whereby they can compound products without having first sought regulato...
  • White House Jumps to Defense of FDA, Other Agencies, over Proposed Budget Cuts

    White House officials are backing up a number of allegations made by several industry watchers regarding the effects of budget sequestration on the US Food and Drug Administration (FDA), noting that, among other things, the cuts could negatively impact drug review times and regulatory science. On 1 March 2013, federal agencies are scheduled to run into the effects of budget sequestration, which calls for annualized budget cuts of approximately 8% for all domestic non-def...