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  • 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....
  • FDA Gets Permanent Director for Reorganized Surveillance 'Super Office'

    The US Food and Drug Administration (FDA) has announced the promotion of Gerald Dal Pan, MD to the position of permanent director of FDA's Office of Surveillance and Epidemiology (OSE), where Dal Pan had been serving as acting director. OSE had recently undergone a reorganization that transformed it from a relatively minor office within the Center for Drug Evaluation and Research (CDER) and into a so-called "super office." Dal Pan has served as the head of OSE since 2005...
  • Post-FDAAA, Regulators Move to Adapt to Changing Risk Models

    With all the attention given to the US Food and Drug Administration's (FDA) approval process, it can sometimes be easy to forget an equal amount of its time is spent on postmarketing issues related, in part, to product safety. Two components of assuring a product's safety involve adverse event reporting (AER) and risk management plans, both of which were the focus of a presentation given at Harvard Medical School in early May 2012. In his presentation, Dr. Gerald Dal Pan...
  • Bill Would Address Medical Device Safety By Giving FDA Additional Authority

    A new bill introduced in the Senate would address medical device safety by giving the US Food and Drug Administration (FDA) additional authority to conduct postmarketing surveillance. "Strong post-marketing surveillance of medical devices will ensure that those that are defective or cause harm can be quickly identified, patients and their physicians can be notified, and dangerous products can be removed from the market," said Senator Jeff Merkley, the bill's chief sponso...