• Woodcock: FDA Strongly Supports Pharmaceutical Track and Trace

    US regulators strongly support plans to introduce a pharmaceutical track and trace plan, the US Food and Drug Administration's (FDA) top drug regulatory official told legislators in testimony on Thursday. Speaking before the House Energy and Commerce Committee's Subcommittee on Health on 25 April 2013, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), sought to answer legislators' questions regarding a long-standing question: What should the...
  • Senate Track and Trace Legislative Draft Includes Lot-Level Requirements and New Penalties

    • 22 April 2013
    A long-delayed and once-abandoned legislative provision that would overhaul the manner in which drug products are overseen in the US is in the process of being reintroduced in the US Senate, legislators announced on 19 April 2013. Background The measure, known as pharmaceutical track and trace, is a collection of tools employed to make sure regulators and companies can determine the authenticity, identity and whereabouts of a particular drug product. It is so named be...
  • PhRMA, GPhA Call for Revival of Pharmaceutical Track and Trace Measures

    The 2012 passage of the Food and Drug Administration Safety and Innovation Act (FDASIA) was remarkable for both the number of reform provisions contained within it and the overwhelming support it received in the US Congress. But that support was not earned without some hard negotiating, and several prominent but controversial provisions were dropped from the final iterations of the bill. Now some of the industry's most prominent voices are taking to the Washington press...
  • Senate Releases Draft Proposal of National Track and Trace System

    • 25 October 2012
    The Senate has released a draft proposal to develop a so-called "track and trace" provision legislators say will increase the security of the US' pharmaceutical supply chain. The system, so named because it would allow regulators to track the movement of a product throughout the supply chain and trace the path of any product found later, is intended to reduce the supply chain's susceptibility to the introduction of counterfeit products without detection. The provision...
  • Groups, FDA Announce Launch of New Clinical Data Standards Harmonization Partnership

    The US Food and Drug Administration (FDA), the Clinical Data Interchange Standards Consortium (CDISC) and the Critical Path Institute (C-Path) have announced the formal launch of a new clinical data standards consortium known as the Coalition for Accelerating Standards and Therapies (C-FAST). Both CDISC and C-Path are data organizations which set many of the global standards used to report data from clinical trials. The partnership between all three organizations w...
  • Report: FDA Considering New Approval Paradigm for Socially Beneficial Drugs

    • 12 October 2012
    The US Food and Drug Administration (FDA) is considering allowing sponsors of select therapies to conduct smaller, faster clinical trials in return for a more restrictive labeling convention that would initially limit its use to a narrower group of patients, FDA Commissioner Margaret Hamburg told a group of scientific advisors. The remarks, reported by Bloomberg , potentially mark a paradigm shift for FDA, which has historically granted marketing licenses for new pr...
  • Study: Priority Review-Approved Drugs Show Significantly More Problems Post-Approval

    More than 34% of drugs approved by Health Canada through its fast-track accelerated review framework ultimately require the addition of serious safety warnings or removal from the market, claims a new research letter published in the Archives of Internal Medicine on 8 October. The study, by Dr. Joel Lexchin, a professor at York University, looked at 434 new active substances (NASs) approved by Health Canada between 1995 and 2010 and assessed whether they later required...
  • Study: Are FDA's Expedited Approval Pathways Worth the Risk?

    The US Food and Drug Administration (FDA) has long been at the center of a passionate debate between industry and patient safety advocates: Is the agency too slow at approving new products, leaving patients to go without needed medications, or is it going too fast, placing those same patients at risk of injury from potentially dangerous products? A new research piece in the Journal of the American Medical Association (JAMA) weighs in on the latter side of the above q...
  • Report: Track and Trace Negotiations Resume in Congress

    • 10 August 2012
    Track-and-trace is dead; long live track-and-trace. Politico reports staff members associated with the House Energy and Commerce (E&C) Subcommittee on Health and the Senate Health, Education, Labor and Pensions (HELP) Committee are meeting over the August congressional recess to restart stalled negotiations over pharmaceutical track-and-trace provisions. Track-and-trace refers to a system by which regulators and pharmaceutical companies can track the movement of...
  • Bill Looks to Establish Provisional Approval Framework for Some Products

    A new piece of legislation proposed in the House of Representatives would amend the Federal Food, Drug and Cosmetic Act (FDCA) to allow for the US Food and Drug Administration (FDA) to issue tentative approvals for products given fast track designation. The bill, H.R. 6288 - The Patient Choice Act of 2012 , is sponsored by Rep. Brian Bilbray (R-CA) and currently is co-sponsored by Reps. Dan Boren (R-OK), Morgan Griffith (R-VA), Duncan Hunter (R-CA) and Jean Schmidt ...
  • Report: Track and Trace Provisions Removed from User Fee Bill

    • 18 June 2012
    Provisions aimed at establishing a system in which drug products would be given unique identifying numbers-a so-called ' track and trace ' system-has been removed from a draft user fee bill intended to fund the US Food and Drug Administration, reports Politico . Negotiators, currently attempting to resolve differences between the House and Senate versions of the user fee bill, have reportedly reached an impasse in their attempt to get track and trace provisions into the...
  • Legislators: To Help Alleviate Drug Shortages, Establish Track and Trace Provisions

    • 13 June 2012
    Two Democratic legislators this week sent a letter to members of the Senate's and House of Representatives' healthcare oversight committees detailing the findings of the legislators' investigation into the effects of the so-called "gray market" on prescription drug shortages. In their 11 June letter, Senator Jay Rockefeller (D-WV) and Representative Elijah Cummings (D-MD) said their investigation had "identified significant risks in the US pharmaceutical distribution cha...