• FDA Lays out Plan for National Medical Device Surveillance System

    On the eve of several public meetings aimed at reworking the US Food and Drug Administration's (FDA) medical device postmarket surveillance system, the agency has released a new plan it says offers its own roadmap on how to improve safety monitoring of potentially dangerous devices. The report, entitled, " Strengthening our National System for Medical Device Postmarket Surveillance ," proposes four changes to be made to the current system of postmarket surveillance: th...
  • Proposed Medical Device Postmarketing Surveillance System Moves Forward

    Regulators with the US Food and Drug Administration (FDA) want to bolster the surveillance of already-approved medical devices, and are calling for public feedback on what the ideal system for conducting such surveillance might look like. In a 30 August Federal Register posting, FDA noted that, "Several high-profile device performance concerns have led some to question whether the Center for Devices and Radiological Health's (CDRH) current postmarket surveillance ...
  • Bill Proposes National Tracking System for Drug Overdoses

    • 21 August 2012
    The Centers for Disease Control and Prevention (CDC) would be tasked with compiling, analyzing and publishing data on drug overdoses if a new piece of proposed legislation is signed into law. The bill, the Stop Overdose Stat Act (S.O.S. Act) , is more broadly intended to reduce the number of drug overdoses occurring in the US. The bill notes more than 36,000 Americans died from drug overdoses in 2008, with approximately three-in-four of these deaths resulting from a...
  • Senators Call on FDA to Strengthen Antibiotic Monitoring

    A group of 13 senators is calling on the US Food and Drug Administration (FDA) to tighten the requirements of recently-released antibiotics guidance documents . The guidance documents, released in April 2012, called for manufacturers to voluntarily limit the "injudicious" use of their antibiotic products in food-producing animals. At the time, FDA said it had received voluntary assurances from Pfizer, Eli Lilly and Merck that they would implement the changes. Definitio...
  • EMA Releases EU-Wide Pharmacovigilance Monitoring Plan

    The European Medicines Agency (EMA) has released an updated management plan to deal with the introduction and proliferation of unsafe medicines into the EU's pharmaceutical supply chain. In its 13 August 2012 posting, EMA explained its plan, dubbed the " regulatory network incident management plan for medicines for human use " has been in operation for nearly three years and applies to all medicines approved within the EU, including those approved by the decentralized an...
  • Report: Monitoring Scandal Involves Top FDA Officials

    Top officials in the US Food and Drug Administration (FDA) were personally involved in reviewing and approving a surveillance program which targeted group of whistleblowers within the agency, reports The Wall Street Journal . The Journal's 7 August report highlights for the first time the involvement of FDA Commissioner Margaret Hamburg, the top official at the US regulatory agency, who was reportedly briefed on the surveillance program shortly after the initiat...
  • Senator Calls on Agencies to Investigate FDA Surveillance Activities

    Senator Charles Grassley (R-IA) has called on two federal agencies open independent investigations into the US Food and Drug Administration (FDA) regarding its surveillance of several employees involved in whistleblowing against the agency and potential violations of both whistleblowing and data protection laws. Both the Department of Health and Human Services (DHHS), FDA's parent organization within the federal bureaucracy, and the Office of Special Counsel , an agen...
  • Regulators, Contractor in Spat Over Accidental Release of Documents

    US regulators and health officials are currently engaged in a 'he-said, she-said' argument with a federal contractor over how nearly 80,000 documents related to a surreptitious surveillance program and potentially confidential industry information were published to an unsecured website, reports The Washington Post . The matter stems from a July 2012 report from The New York Times , who, along with lawyers from the National Whistleblowers Foundation, had discovered...
  • Court Orders FDA to Release Thousands of Documents on Surveillance Program

    The US Food and Drug Administration (FDA) has been ordered by a federal judge to release thousands of documents to an attorney representing former employees of the agency who now allege they were the subject of an illegal surveillance program. Judge James Boasberg of the District Court of DC sided with the National Whistleblowers Center (NWC) at the 23 July hearing, and has ordered the agency to turn over more than 4,000 pages of documents related to the case to NWC by...
  • Prominent Senator Slams FDA over Surveillance Program

    It's safe to say that Senator Charles Grassley (R-IA) is less than enamored with the US Food and Drug Administration (FDA) as of late. The Senator, who has been investigating the agency's alleged treatment of nine whistleblowers and a related surveillance program, took to the Senate floor on Tuesday, 17 July to lambaste the agency's actions . FDA has "forgotten that it works for the American public," said Grassley at the top of his remarks. "This is an agency that has ...
  • Pressure Mounts on FDA Over Surveillance Scandal

    The US Food and Drug Administration (FDA) is facing mounting pressure from both Congress and outside groups after The New York Times published an exposé on a clandestine monitoring program at the agency. The entire case stems from a report in January 2012 by The Washington Post , which revealed that a group of former FDA medical reviewers had filed a lawsuit against the agency for allegedly intercepting communications between them and outside oversight entities...
  • Study: FDA's Risk Communications and Warnings Not as Effective as Hoped

    A new meta-analysis in the journal Medical Care looking at the effect of risk communications sent out by the US Food and Drug Administration (FDA) finds an inconsistent response to FDA's attempts to warn the public about the potential harms associated with some medications. The study looked at 49 studies published between 1990 and 2010 which evaluated the impact of FDA risk communications, including safety alerts, letters to healthcare providers and black box warnings....