• User Fee Bill Advances to Vote in Senate

    The Food and Drug Administration Safety and Innovation Act (FDASIA) , the Senate's iteration of a package of user fee legislation and other regulatory reforms, advanced in the Senate on 21 May, moving the legislation one step closer to passage. On 21 May, a " motion to proceed to consideration of measure ," was passed, allowing the bill to advance for final debate and markup. A final vote on FDASIA is expected to occur between 23-25 May. The legislation was delayed ...
  • With EDQM Absent, EFPIA Launching Own Anti-Counterfeit Strategy

    • 03 May 2012
    The European Federation of Pharmaceutical Industries and Associations (EFPIA) announced it has signed on to a Memorandum of Understanding (MoU) that it says will help to set up a harmonized system of international standards to prevent counterfeit products from entering or proliferating within the pharmaceutical supply chain. EFPIA said the MoU, reportedly developed jointly between groups representing pharmacists, wholesalers and distributors, adopts what is known at the ...
  • 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...
  • EDQM Continuing Development of New, Comprehensive Anti-Counterfeiting Strategy

    • 18 April 2012
    The European Directorate for Quality in Medicines and Healthcare ( EDQM ), the Council of Europe's (EC) pharmaceutical standards body, announced it is continuing to develop and expand a new anti-counterfeiting strategy it says will reduce pharmaceutical-related crime. In its 18 April announcement, EDQM said the multi-layer legislative strategy aims to increase, among other things, training for inspection officials from EC member states, increased inspection and testing a...
  • Hamburg Calls for New Authority, Strengthened Anti-Counterfeit Laws

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg said in a statement she believes existing pharmaceutical anti-counterfeiting laws are grossly inadequate to deter illicit activity, saying counterfeiters deserve "more severe consequences." Hamburg's 10 April statement on FDA Voice , FDA's blog, made clear she believes the Federal Food, Drug and Cosmetic Act (FD&C Act) is outdated. "[The FD&C Act ] was enacted in 1938, long before there was a...
  • Hamburg: FDA Needs More Anti-counterfeit Authority, International Track and Trace Cooperation

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg said the agency needs more authority to deal with counterfeit drug products like the fake Avastin that found its way into the supply chain last month. Speaking with CNN , Hamburg noted the fake Avastin has "focused new attention and concern on counterfeit drugs," which she hopes will make it easier to work with Congress. "They're considering some legislation that would give the FDA stronger authority...
  • PDUFA Draft Makes Changes to FDA Mission, Regulatory Pathways

    A new draft of the Prescription Drug User Fee Act ( PDUFA ) legislation that provides nearly half of the US Food and Drug Administration's (FDA) funding makes several significant changes to the agency, reports BioCentury . A discussion draft circulating among House Republicans "includes an updated FDA mission, language intended to expand accelerated approval and incentives for antibiotic drug development." The accelerated approval language is reportedly similar to l...
  • New Bipartisan Bill to Expand Accelerated Approval Pathway

    [Updated 6 March to Include Link to FAST Act.] An upcoming piece of legislation advanced by Reps. Cliff Stearns (R-FL) and Edolphus Towns (D-NY) would expand the US Food and Drug Administration's (FDA) use of the accelerated approval pathway , reports BioCentury . The Faster Access to Specialized Treatments (FAST) Act is reportedly similar to Sen. Kay Hagan's (R-NC) bill, the Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act ,...
  • Spotlight on Counterfeiting After Fake Avastin Found in US

    Counterfeit copies of Avastin-an oncology drug with numerous indications-is casting a harsh spotlight on the safety of the pharmaceutical supply chain and causing experts to ask how it can be strengthened. Perhaps the most prominent idea put forth by experts is a so-called 'track and trace' system for verifying pharmaceutical integrity. The US Food and Drug Administration (FDA) is expected to release a proposal for such a system within the coming year, notes the Associ...